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# Flex Databases

## Sitemaps

- [XML Sitemap](https://flexdatabases.com/sitemap.xml): Contains all public & indexable URLs for this website.

## Posts

- [Data Protection Considerations](https://flexdatabases.com/data-protection-considerations/) - version 03 Flex Databases provides software solutions supporting clinical trial conduct across all stages. One of our key priorities is ensuring the confidentiality and integrity of customer data. We are committed to maintaining high standards of data protection and privacy. Flex Databases implements robust security controls to protect customer data, ensure compliance with applicable regulations,
- [Data Protection Statement](https://flexdatabases.com/data-protection-statement/) - Effective as of 17-May-2018 Flex Databases provides software solutions that support clinical trials conduction at all stages and one of our main priorities is confidentiality and integrity of our customers data. Flex Databases is concerned about data protection and privacy issues. This Statement describes basic principles of the data collection, usage, and disclosure. This Statement

## Pages

- [Home](https://flexdatabases.com/) - Software for Life Sciences to manage all in one trials, documents, quality & people. eClinical system for Sponsors, CROs, Academic companies.
- [Pharmacovigilance](https://flexdatabases.com/pharmacovigilance/) - Flex Databases Pharmacovigilance is a comprehensive drug safety database that ensures robust and compliant pharmacovigilance activities both within clinical trials and post-approval stage.
- [eTMF in clinical trials (eTMF)](https://flexdatabases.com/trial-master-file/) - Clinical trial eTMF software by Flex Databases. Manage, organize, and review trial documents with automated filing, metadata control, and full inspection readiness.
- [All-in-One CTMS Software](https://flexdatabases.com/clinical-trial-management-system/) - All-in-One CTMS Software. Clinical Trial Management System for clinical development process and beyond. Evidence-based decisions. More information, less efforts.
- [LMS & QMS](https://flexdatabases.com/learning-management-system/) - Centralized and automated management of trainings and all quality-related activities designed for teams involved in clinical research.
- [Project Management & Budgeting](https://flexdatabases.com/project-management-budgeting/) - Simplify project management and budgeting. Create budgets, convert to project plans in one click, track progress, generate reports, and automate invoicing.
- [DMS (Document Management System)](https://flexdatabases.com/document-management-system/) - A comprehensive system designed to enhance efficiency and compliance throughout your document lifecycle in clinical trials.
- [Electronic Data Capture (EDC)](https://flexdatabases.com/edc-electronic-data-capture/) - Scalable by Design Flex EDC includes powerful modules tailored to each role in the clinical study. Compliance & Security Flex EDC is validated and certified for: Trusted Performance "We reduced study build time by over 40% and launched our trial in 21 days using Flex EDC. The built-in RTSM and real-time dashboards made a real
- [Cookie Policy](https://flexdatabases.com/cookie-policy/) - This page provides comprehensive information about how we use cookies on our website to enhance your browsing experience, improve website performance, and deliver personalized content. Cookies are small text files that are stored on your device when you visit our site. They help us understand how visitors interact with our website, allowing us to offer
- [Open Positions](https://flexdatabases.com/open-positions/) - We develop tools that speed up clinical research and support global health improvements. What you do here matters – for science, for patients, & for the future.
- [Company](https://flexdatabases.com/company/) - Our company was founded in 2011 and to this day remains privately owned by our working managers. Our HQ is in Prague, Czech Republic, with additional offices in Switzerland, the U.S., and Turkey.
- [Our clients](https://flexdatabases.com/our-clients/) - Trusted by the market leaders since 2011. We are in a great company of life science innovators. The best of CROs, Pharma, and Biotech.
- [Why clients choose Flex Databases](https://flexdatabases.com/why-choose-flex-databases/) - See why CROs, sponsors, and research organizations choose Flex Databases for clinical trial management. Real client experiences and partnership stories.
- [Contacts](https://flexdatabases.com/contacts/) - Flex Databases s.r.o., Plynární 1617/10, Holešovice, 17000 Praha 7, Prague, Czech Republic. Phone number +420 296 399 366
- [Pricing](https://flexdatabases.com/pricing/) - Flex Databases provides subscription-based software with a flexible pricing policy. Clients pay SaaS Fee based on the number of users and the number of modules in the contract, monthly or quarterly.
- [Implementation](https://flexdatabases.com/implementation/) - Estimated timeline for implementation is from 3 to 10 weeks, depending on the complexity of client’s requirements and client’s involvement.
- [Compliance](https://flexdatabases.com/compliance/) - We understand the importance of compliance and accuracy in clinical trials and take a risk-based approach to security. 21 CFR Part 11, HIPAA, GDPR compliant.

## Blog

- [Why FluoGuide Chose Flex Databases as eTMF and CTMS Provider](https://flexdatabases.com/blog/why-fluoguide-choose-flex-databases/) - See how FluoGuide improved clinical trial management with Flex Databases, gaining flexible workflows, intuitive TMF, automation, and expert support.
- [Protocol Deviations Start Earlier Than You Think](https://flexdatabases.com/blog/protocol-deviations-start-earlier-than-you-think/) - Most sponsors associate protocol deviations with events that occur later in a clinical trial, like missed visits or incomplete documentation. In reality, one of the earliest and most consequential protocol deviations is happening during patient randomization. Randomization is often perceived as a simple operational step:patient enrolled, button clicked, treatment assigned. But under the pressure of
- [Why Long-Established eClinical Platforms Are Slowing Down Modern Clinical Trials ](https://flexdatabases.com/blog/long-established-eclinical-platforms/) - Not all eClinical platforms are built alike. Learn why modern, connected systems help sponsors streamline trials, reduce manual work, and scale globally.
- [Customize CTMS Dashboards for Every User](https://flexdatabases.com/blog/customize-ctms-dashboards-for-every-user/) - Every clinical trial role requires different information. CRAs need to track upcoming monitoring visits, Project Managers need study performance metrics, and clinical operations teams need enrollment and site activity data. In this video, see how Flex Databases CTMS allows every user to create a personalized dashboard without affecting other users. Learn how to add or
- [How ITS Cut Manual Safety Tracking by 60% and Strengthened PV Oversight Across Clinical Trials](https://flexdatabases.com/blog/its-pharmacovigilance-case-study/) - How ITS reduced manual safety tracking by 60% using Flex Databases Pharmacovigilance, improving workflow efficiency and PV oversight.
- [Is Your EDC Really Modern If Someone Still Has to Re-Enter Every Serious Adverse Event?](https://flexdatabases.com/blog/is-your-edc-really-modern/) - Clinical industry has finally embraced AI, sponsors run decentralized trials and data is now collected in real time. But still one of the most critical workflows in every study - handling adverse events (AEs) - surprisingly depends on copy-paste. Most sponsors assume that if they have an Electronic Data Capture (EDC) system and a Pharmacovigilance
- [Validating AI in GxP Environments: The Flex Databases Approach to eTMF Compliance](https://flexdatabases.com/blog/validating-ai-in-gxp-environments-the-flex-databases/) - How Flex Databases validates AI in eTMF: GAMP 5-aligned risk assessment, testing, and ongoing monitoring for inspection-ready TMF compliance.
- [The Quiet Revolution in TMF: How AI Document Classification Turns Routine into a Background Task](https://flexdatabases.com/blog/the-quiet-revolution-in-tmf-ai/) - AI-assisted TMF classification is already saving clinical teams thousands of hours. See the numbers, the limits, and how human oversight stays in.
- [Investigator Site File Management with Flex Databases](https://flexdatabases.com/blog/investigator-site-file-management-with-flex-databases/) - Manage ISF workflows across sponsors, CRAs and sites with role-based dashboards, structured reviews, and full audit traceability in one platform.
- [Senior Project Manager | eClinical](https://flexdatabases.com/blog/senior-project-manager-eclinical/) - We are looking for seasoned Senior Project Managers who is ready to take full ownership of high-impact projects. At our core, we value delivery over slides and results.
- [Looking for an Enterprise eClinical Solution? There Is More to Consider](https://flexdatabases.com/blog/looking-for-an-enterprise-eclinical-solution/) - Explore what matters most in an enterprise eClinical solution: scalability, compliance, integration, configurability, and long-term clinical trial success.
- [Vendor Oversight Under ICH E6(R3): Why Compliance Expectations Are Higher Than Ever](https://flexdatabases.com/blog/vendor-oversight-under-ich-e6r3/) - Vendor oversight has always been part of clinical trial compliance, but ICH E6(R3) has significantly raised expectations for sponsors and technology vendors alike.
- [Clinical Trials Management Software: Key Features for CROs](https://flexdatabases.com/blog/clinical-trials-management-software-features-for-cros/) - Clinical Trials Management Software for CROs: key features for managing studies, sites, monitoring, finances, reporting, compliance, and scalability.
- [Speaker Announcement Anna Petrovskaya at QA Virtual Conerence](https://flexdatabases.com/blog/anna-petrovskaya-at-qa-virtual-conerence/) - “Risk Management Automation in the GCP R3 Era” will explore why traditional, document-based risk management approaches are no longer enough
- [Electronic Data Capture - Everything You Need To Know](https://flexdatabases.com/blog/electronic-data-capture-everything-you-need-to-know/) - What is Electronic Data Capture? Electronic Data Capture (EDC) is an electronic system applied to clinical trials for capturing, managing, and storing patient data. Instead of paper-based forms, investigators enter clinical trial information directly into a secure, web-based site. EDC systems validate data integrity, reduce errors, and automate the data collection process - accelerating clinical
- [Flex Databases x SOLTI taking the stage at #OCT2026](https://flexdatabases.com/blog/flex-databases-x-solti-at-oct2026/) - We’re heading to Barcelona for OCT 2026. And this time, we’re bringing a real story with us! Our colleague Evgenia will be speaking alongside Jaume Costa from SOLTI, our dear client and long-term partner, about the question many teams still struggle with: Who should own your eClinical systems: sponsor or CRO? There is no “best
- [TMF Blinding: Removing the Complexity of Managing Blinded Studies](https://flexdatabases.com/blog/tmf-blinding-removing-the-complexity-of-managing-blinded-studies/) - TMF Blinding is implemented directly at the project level within the Trial Master File module. It introduces a dedicated blinding layer that operates independently.
- [CTMS for CRO Financial Management: Managing Clinical Trial Budgets and Investigator Payments](https://flexdatabases.com/blog/ctms-for-cro-financial-management/) - Learn how a CTMS helps CROs manage clinical trial budgets, investigator payments, and sponsor invoicing. Improve financial transparency and efficiency.
- [Risk-Based Monitoring (RBM) in Clinical Trials: A Comprehensive Guide to Modern Oversight](https://flexdatabases.com/blog/risk-based-monitoring-rbm-in-clinical-trials/) - Master Risk-Based Monitoring in clinical trials. Learn how RBM in clinical trials improves data quality, ensures ICH E6 (R2) compliance, and cuts costs by 25%.
- [Why MapLight Therapeutics Chose Flex Databases’ CTMS and eTMF](https://flexdatabases.com/blog/maplight-therapeutics-chose-flex-databases-ctms-and-etmf/) - MapLight Therapeutics selected Flex Databases to support its clinical trial operations with an integrated CTMS and eTMF platform.
- [Open Position: ASP.NET Developer](https://flexdatabases.com/blog/asp-net-developer/) - Our clients include biotech and pharmaceutical companies, as well as Contract Research Organizations (CROs) that outsource clinical trial management.
- [Open Position: System Analyst ](https://flexdatabases.com/blog/open-position-system-analyst/) - We are driven by a mission to make a meaningful impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies worldwide. Key Responsibilities Requirement Gathering & Documentation: Elicit requirements through interviews, workshops, and mind mapping. Create, refactor, and maintain up-to-date system documentation: URS (User Requirements Specification): User-level requirements
- [What Will Inspectors Check in Clinical Trials in 2026?](https://flexdatabases.com/blog/clinical-trial-inspections-2026/) - Learn what FDA and EMA inspectors will check in 2026, including data integrity, AI governance, audit trails, and systems used in clinical trials.
- [Immutep Selects Flex Databases eTMF to Improve Oversight and Compliance](https://flexdatabases.com/blog/immutep-selects-flex-databases-etmf/) - Immutep GMBH shares perspective on selecting Flex Databases and the experience of implementing the eTMF system. Read more about eTMF implementation and...
- [Introducing Risk Management in QMS: a modern, structured way to prevent issues before they happen](https://flexdatabases.com/blog/introducing-risk-management-in-qms/) - In clinical research, “quality” is not only about fixing deviations after the fact. It’s about predicting what can go wrong, acting early, and proving control because risks can affect subject safety, data integrity, and the overall conduct of a study. That is exactly why Risk Management exists: it turns uncertainty into a disciplined, repeatable process
- [Business Development Manager](https://flexdatabases.com/blog/business-development-manager-associate/) - We are looking for a Business Development Manager/Associate to join and contribute to the company's business development and sales team in Europe and deliver sales goals. Responsibilities: Deliver on sales goals of eClinical Software as a Service product for pharmaceuticals Actively search for new potential clients Understand the needs of the potential clients, qualify them
- [Open Position: System Analyst](https://flexdatabases.com/blog/open-position-system-analyst__trashed/) - We are driven by our high mission to make an impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies. We work globally with clients all over the world, with our own offices located in the Czech Republic, Switzerland, Turkey, and the US. Key responsibilities:
- [Flex Databases team is looking for a Helpdesk Specialist to join one of our Helpdesk team. ](https://flexdatabases.com/blog/helpdesk-specialist/) - We are driven by our high mission to make an impact on the Life Sciences industry. We provide a flexible e-Clinical software system for Clinical Research Organizations (CROs) and pharmaceutical companies. As a Helpdesk Specialist at Flex Databases, you are going to be at the forefront to support our clients’ clinical operations teams, which means daily work for the benefit of people
- [The Power of Unified eClinical Platforms: How All-in-One Solutions with API Integration Are Transforming Clinical Trials](https://flexdatabases.com/blog/the-power-of-unified-eclinical-platform/) - Inside the Toolbox: eTMF, CTMS, PV, and EDC Running clinical trials today involves more than collecting data or monitoring patient visits. It’s about keeping everything connected, compliant, and on schedule while managing growing complexity. That’s where unified eClinical platforms come in, and at the core of these systems are several essential modules: eTMF, CTMS, PV,
- [Flex Databases Wins Three Awards at the Clinical Trials Arena Excellence Awards 2025](https://flexdatabases.com/blog/clinical-trials-arena-award/) - Flex Databases has been officially recognized as a triple-category winner in the Clinical Trials Arena Excellence Awards 2025, receiving top honors in Innovation, Product Launches, and Business Expansion. This achievement highlights our growing impact on the global clinical research landscape and reinforces our position as one of the most advanced eClinical platforms in the industry.
- [We Are Hiring: Project Manager](https://flexdatabases.com/blog/hiring-project-manager/) - Flex Databases team is looking for a Project Manager to join our Customer Success Management team, based in our Prague office. While this role can be fully remote within Czechia, you must be available to visit the office for occasional client meetings. Preferred location: Prague. Fluency in German is essential for this position, as you
- [We Are Hiring: Associate Project Manager](https://flexdatabases.com/blog/associate-project-manager/) - Applications for this position are now closed and no longer being reviewed. Flex Databases is looking for an Associate Project Manager to join our Customer Success Management team, based in our Prague office. While this role can be fully remote within Czech Republic, you must be available to visit the office for occasional client meetings.
- [We Are Hiring: Marketing Associate ](https://flexdatabases.com/blog/we-are-hiring-marketing-associate/) - Applications for this position are now closed and no longer being reviewed. We are looking for a proactive and organized Marketing Associate to join our Marketing team and contribute to building a strong brand presence, managing outreach activities, and supporting day-to-day marketing operations. This role combines coordination, communication, and creativity. It is ideal for individuals who
- [We Are Hiring: Scrum Master](https://flexdatabases.com/blog/we-are-hiring-scrum-master/) - 📍Remote 💼Full-Time Applications for this position are now closed and no longer being reviewed. Flex Databases is driven by our high mission to make an impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies. We work globally with clients all over the world, with
- [We Are Hiring: System Analyst](https://flexdatabases.com/blog/we-are-hiring-system-analyst/) - Applications for this position are now closed and no longer being reviewed. We are driven by our high mission to make an impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies. We work globally with clients all over the world, with our own offices
- [New Microsoft 365 Collaboration in Flex Databases TMF](https://flexdatabases.com/blog/new-microsoft-365-collaboration-in-flex-databases-tmf/) - Flex Databases Solves One of the Biggest Document Management Headaches Clinical teams have long struggled with one persistent problem: managing TMF documents across multiple systems, versions, and stakeholders. Switching between platforms, downloading files, losing track of versions, and waiting for colleagues to finish editing slows down operations and increases compliance risks. With this update, Flex
- [BIOTRONIK Selects Flex Databases as a Major System to Cover Clinical Trial Related Activities](https://flexdatabases.com/blog/biotronik-selects-flex-databases/) - BIOTRONIK, a leading global medical device company, has selected Flex Databases as its trusted eClinical partner to streamline and enhance the management of its clinical trial operations through Flex Databases’ unified platform. Comprehensive Functionality and Strong ROI Following a rigorous evaluation process, BIOTRONIK chose Flex Databases for its broad functionality, competitive pricing, and exceptional return
- [Flex Databases is fully ready for the transition to the new TMF Standard Model (TMF SM)!](https://flexdatabases.com/blog/the-transition-to-the-new-tmf-standard-model-tmf-sm/) - 📑 The TMF Reference Model, widely used across the industry for more than a decade, is being reintroduced under a new name: TMF Standard Model (TMF SM).🚀 Instead of releasing Version 4 of the TMF Reference Model, the upcoming update will debut as TMF Standard Model Version 1 (v1). This rebranding represents more than just
- [Speaker Announcement | Case Study of Data Migration: A Nightmare or a Real Need in 2025?](https://flexdatabases.com/blog/speech-case-study-of-data-migration-a-nightmare-or-a-real-need-in-2025/) - We are excited to have Marietta Sarkisian, Global Director, Business Development & Marketing at Flex Databases, take the stage with a powerful case study: “Data Migration: A Nightmare or a Real Need in 2025?” She will cover: ✅ Partnering for Transformation – Why SOLTI chose Flex Databases to overcome CTMS limitations✅ Migration Process – Structured
- [Flex Databases Interview with Harbor Clinical](https://flexdatabases.com/blog/flex-databases-interview-with-harbor-clinical/) - Our Head of Business Development and Marketing, Marietta Sarkisian, sat down with Ajay Sadhwani, Senior Vice President at Harbor Clinical, to talk about their experience with Flex Databases Pharmacovigilance module.In this conversation, Ajay shares how smooth implementation, responsive customer support, and the flexibility of our PV system helped Harbor Clinical streamline operations and enhance productivity.Watch
- [Flex Databases team is looking for a Technical Writer to join our team.](https://flexdatabases.com/blog/flex-databases-technical-writer/) - Applications for this position are now closed and no longer being reviewed. We are driven by our high mission to make an impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies. We work globally with clients all over the world, with our own offices
- [Risk-Based Monitoring with Flex Databases ](https://flexdatabases.com/blog/risk-based-monitoring-rbm/) - Flex Databases combines deep clinical expertise with advanced technology to deliver a smarter approach to trial oversight. Our Risk-Based Monitoring (RBM) framework helps sponsors and CROs focus on what matters most, reduce effort and cost, and make faster, data-driven decisions – supported by Flex Databases’ EDC, central/remote monitoring, and AI analytics. Why Risk-Based Monitoring? Focus
- [Alithia Chooses Flex Databases as eTMF provider](https://flexdatabases.com/blog/alithia-choose-flex-databases-etmf/) - Alithia Life Sciences is a full-service Contract Research Organization dedicated to deliver high-quality clinical trial management solutions. With a strong focus on efficiency, compliance, and operational excellence, Alithia partners with pharmaceutical and biotech companies to ensure the seamless execution of clinical trials. To further enhance its document management and trial oversight, the company selected Flex
- [Subject Tracking & Invoicing - Data Import Wizard.](https://flexdatabases.com/blog/data-import-wizard/) - Cross-site budget setup can turn into hours of manual per-subject cost entry, slowing teams down and creating error risks.With Flex Databases’ Subject Tracking & Invoicing, you can now import Per Subject Costs directly from Excel using the Data Import Wizard.✔ Speed up site budget setup✔ Reduce manual entry and errors✔ Import across projects (with the
- [ICSR Reporting](https://flexdatabases.com/blog/icsr-reporting/) - 📑 Tracking regulatory submissions shouldn’t require endless spreadsheets.But for many PV teams, managing ICSR reporting across agencies means manual tracking, external task lists, and risk of missed deadlines.With Flex Databases’ improved Pharmacovigilance Submissions Tracker, everything is now in one place:✔ Define flexible submission rules by drug, project, and conditions✔ Configure statuses to match your internal
- [Query Chat: Smarter Way to Manage Data Issues in Monitoring](https://flexdatabases.com/blog/query-chat-smarter-way-to-manage-data-issues-in-monitoring/) - Managing monitoring activities often means juggling multiple people, documents, and communication channels. Without the right tools, discussions about data discrepancies get lost in emails or chats, review cycles are disrupted, and KPIs are affected by unnecessary report declines. To solve these pains, CRAAM introduces a dedicated Query feature - designed to make handling data issues
- [TMF Quality Review - Video](https://flexdatabases.com/blog/tmf-quality-review-video/) - 📂 Last-minute TMF quality reviews cause stress, missed documents, and higher audit risks.With Flex Databases, you avoid the scramble - reviews are structured, transparent, and always under your control.With Flex Databases, you get:✅ Control over the process✅ Full transparency and traceability✅ Less stress before audits✅ Clear outcomes in one report🎥 See how it works in
- [Duplicate Detection into Flex Databases eTMF](https://flexdatabases.com/blog/duplicate-detection-into-flex-databases-etmf/) - Ever uploaded a document to your Trial Master File only to realize it was already there?You’re not alone! Duplicates waste time, clutter your TMF, and create compliance risks.That’s why we built duplicate detection into Flex Databases eTMF.✅ Real-time scanning as soon as you upload✅ Checks both file name and document content✅ Skip, replace, or link
- [FDA Publishes Final Guidance on Computer Software Assurance (CSA)](https://flexdatabases.com/blog/fda-guidance-on-csa/) - The FDA has just released its final guidance on Computer Software Assurance (CSA) for Production and Quality System Software. This marks a shift from traditional, document-heavy Computer System Validation (CSV) to a risk-based, critical thinking–driven approach. What does this mean? Focus on high-risk features that impact patient safety and product quality Right-sized documentation – evidence
- [Duplicate search in our TMF](https://flexdatabases.com/blog/duplicate-search-in-our-tmf/) - Ever uploaded a document to your Trial Master File only to realize it was already there?You’re not alone! Duplicates waste time, clutter your TMF, and create compliance risks.That’s why we built duplicate detection into Flex Databases eTMF.✅ Real-time scanning as soon as you upload✅ Checks both file name and document content✅ Skip, replace, or link
- [What is CTMS? Frequently Asked Questions](https://flexdatabases.com/blog/what-is-ctms-faq/) - What is CTMS A CTMS – Clinical Trial Management System is a software solution that facilitates more streamlined management and monitoring of clinical trials. Clinical operations teams like project managers, CRAs, and study coordinators in pharmaceutical firms, CROs, and biotech firms use the tool to oversee everything from site selection and subject recruitment to monitoring
- [How to Choose the Right ePRO Software](https://flexdatabases.com/blog/how-to-choose-epro-software/) - ePRO stands for electronic Patient-Reported Outcomes. It is software that allows patients to report how they feel or what symptoms they are experiencing during a clinical trial-using a phone, tablet, or computer. Instead of writing answers on paper, patients use ePRO to enter their responses directly into the system. ePRO software is widely used in
- [Why Sponsors Are Pushing CROs to Adopt Modern CTMS Solutions](https://flexdatabases.com/blog/why-sponsors-are-pushing-cros-to-adopt-modern-ctms-solutions/) - Nowadays the relationship between sponsors and contract research organizations (CROs) has evolved. What once was a simple outsourcing arrangement has become a strategic partnership, where both parties are expected to operate with full transparency, speed, and strict adherence to regulatory standards. Sponsors are no longer satisfied with periodic updates and disconnected spreadsheets. They want real-time
- [Checklist: Migrating from a Legacy TMF to an eTMF](https://flexdatabases.com/blog/checklist-migrating-from-a-legacy-tmf-to-an-etmf/) - Many clinical trial teams still rely on a legacy TMF - whether that means physical binders or outdated digital folders lacking structure and traceability. These systems often fall short in today’s increasingly regulated, fast-paced environment, making oversight and compliance more difficult. That’s why more sponsors and CROs are transitioning to a modern eTMF. A modern
- [Synchronizing safety data from EDC/eCRF with Flex Databases Pharmacovigilance](https://flexdatabases.com/blog/edc-pv-connection/) - Many years since the appearance of different platforms and systems for clinical trial operations, there has been a question about making all the systems work synchronized. For most parts of the platforms and systems, it occasionally became possible, though Drug Safety Specialists still have to lead their pharmacovigilance processes independently. Having the objective to streamline
- [How to Integrate CTMS with EDC](https://flexdatabases.com/blog/how-to-integrate-ctms-with-edc/) - Clinical Trial Management Systems (CTMS) and Electronic Data Capture systems are critical to the effective management of clinical trials. By integrating CTMS and EDC, organizations can streamline processes, enhance data quality, and improve overall efficiency. Here are five key tips to ensure a successful CTMS and EDC integration. Effortless Integration of Flex Databases CTMS with
- [What CROs Should Look for in CTMS and eTMF During a Tender](https://flexdatabases.com/blog/ctms-etmf-tender-guide/) - When preparing a tender for a Clinical Trial Management System (CTMS) and an electronic Trial Master File (eTMF), CROs must choose solutions that meet sponsor expectations and improve operational efficiency while keeping studies inspection-ready. The right choice affects study delivery, compliance, and client satisfaction. Below are the key factors CROs should consider. Regulatory Compliance and
- [Integrations in Clinical Trials: An IT/ETL Perspective](https://flexdatabases.com/blog/integrations-in-clinical-trials-an-it-etl-perspective/) - How Flex Databases connects your study ecosystem - reliably, securely, and at scale. Integration connects software systems so they can share data automatically, eliminating duplicate entry. In clinical trials, the most common pattern is EDC → CTMS, followed by CTMS → ERP/Finance and CTMS → BI/analytics. Flex Databases supports three delivery models: Managed API integration,
- [Configurations under user control](https://flexdatabases.com/blog/configurations-under-control/) - There are many factors to consider when purchasing a clinical trial management software – from regulatory requirements to the sponsor’s wishes. Many of these factors could be summarized to a need. To comply with the need, you create a checklist with major and minor features and flows to implement. But, keeping in mind that every business is
- [Regulatory Binder Checklist for Clinical Trial Documentation](https://flexdatabases.com/blog/regulatory-binder-checklist-for-clinical-trial-documentation/) - A regulatory binder is crucial for managing clinical trial documents, it ensures compliance with regulations, and makes audits easier. It helps keep important documents organized and readily accessible for trial monitors, auditors, and regulatory authorities, and serves as a useful reference for the research team. While it's not legally required, maintaining a regulatory binder is
- [Achieving compliance, streamlined training, and transparency in SOPs management with LMS](https://flexdatabases.com/blog/learning-management-system-benefits/) - Nowadays, Learning Management System (LMS) acts as a virtual hub that helps not only with documentation, administration, reporting, tracking, delivery, and automation of training but mainly with audits and SOPs management. LMS has some crucial business benefits: Cost savings: Moving training online significantly reduces company spending on employee travel, facilities, and instructors. Centralized training delivery: LMS acts
- [How we grow our product but not prices through the years](https://flexdatabases.com/blog/how-we-grow-our-product-but-not-prices/) - When you decide on the eClinical system or any other software provider, there are many questions to ask – compliance, efficiency, security, support, etc. And at the end of the day, it is also how much I pay vs. what I get for it? What about the money? How did SaaS pricing grow in proposals
- [The Flex Databases team is looking for a QA Engineer / Tester. ](https://flexdatabases.com/blog/looking-for-a-qa-engineer-tester/) - 📍Remote 💼Full-Time Applications for this position are now closed and no longer being reviewed. We are driven by our high mission to make an impact in the Life Sciences industry. We provide flexible e-Clinical software systems for Clinical Research Organizations (CROs) and pharmaceutical companies. We work globally with clients all over the world, with our
- [Key Changes to EU Pharmacovigilance Regulation: What You Need to Know](https://flexdatabases.com/blog/eu-pharmacovigilance-regulation-july-2025/) - In July 2025, the European Commission adopted Commission Implementing Regulation (EU) 2025/1466, amending Regulation (EU) No 520/2012. The changes aim to strengthen pharmacovigilance, reduce unnecessary administrative burden, and align EU requirements with global best practices. Most provisions apply from 12 February 2026, with certain Eudravigilance updates taking effect in August 2025. Why the Changes Were
- [How Much ROI Can You Expect from eTMF and CTMS? ](https://flexdatabases.com/blog/etmf-ctms-roi/) - A Comparative Look at Europe vs. US Markets In clinical operations, time is money – but how much money can technology really save you?We analyzed the return on investment (ROI) for implementing electronic Trial Master File (eTMF) and Clinical Trial Management Systems (CTMS) based on real-world benchmarks. By modeling savings from reduced manual effort, error
- [We Are Hiring: ASP.NET Developer](https://flexdatabases.com/blog/we-are-hiring-asp-net-developer/) - Applications for this position are now closed and no longer being reviewed. The Flex Databases team is seeking an ASP.NET Developer to join one of our Software Development teams. Our product is a SaaS eClinical platform designed for managing clinical trials and various business processes in the pharmaceutical industry. Our clients include biotech and pharmaceutical
- [Flex Databases at EUCROF 2025](https://flexdatabases.com/blog/flex-databases-at-eucrof-2025/) - We are thrilled to announce that Flex Databases is a proud sponsor of EUCROF 2025, taking place from February 2-4, 2025! Our team members, Tamara Prekodravac and Evgenia Michalchuk-Vrablik, will represent us at this prestigious event, where industry leaders come together to drive innovation and collaboration in clinical research. This year’s event will cover important
- [Data Hosting with Confidence – Flex SaaS for Clinical Trial Environments ](https://flexdatabases.com/blog/data-hosting-with-confidence-flex-saas-for-clinical-trial-environments/) - At Flex Databases, we deliver a SaaS solution purpose-built for clinical trials – offering global accessibility with full transparency and control over where your data resides. Not a Public Cloud. A Dedicated SaaS Platform You Can Trust. Flex Databases is an EU-based company operating globally and trusted by life sciences organizations for secure, validated SaaS
- [Everest CRO Experience with Flex Databases](https://flexdatabases.com/blog/everest-cro-experience-with-flex-databases/) - Dana Leff Niedzielska, MBA, SVP of Global Clinical Operations at Everest Clinical Research, shares her experience using Flex Databases’ CTMS and eTMF. In this interview, Dana highlights how Flex Databases supports Everest CRO’s clinical operations. Learn why Everest chose Flex Databases as their trusted technology partner and why they continue to rely on and trust
- [ICH GCP E6(R3) is about to go live in the EU](https://flexdatabases.com/blog/ich-gcp-e6r3-is-about-to-go-live-in-the-eu/) - The countdown is on - ICH GCP E6(R3) is about to go live in the EU, and everyone’s getting prepared!As a service provider (you caught that new R3 definition during training, right?), Flex Databases is here to support you through the transition. Let’s highlight a few areas that are especially important for our clients:✅3.6.8 The
- [What’s New This June: Smarter Imports, Cleaner Reports, and More Flexible APIs](https://flexdatabases.com/blog/whats-new-this-june/) - Pre-Validation for CRA Reports The Monitoring Activity report tab now features a validation preview. Users can check for missing fields and review validation messages before generating the final report - enabling more accurate submissions and reducing the need for rework. Bulk Imports for Milestones and Assumptions You can now bulk import project milestones and assumptions
- [Hiring Closed:  eClinical Product Trainer](https://flexdatabases.com/blog/we-are-hiring-eclinical-product-trainer/) - Applications for this position are now closed and no longer being reviewed. At Flex Databases, we’re on a mission to make a real impact in the Life Sciences industry with our CTMS, eTMF, and other systems for Life Sciences. Our platform supports Clinical Research Organizations and pharmaceutical companies across the globe in managing the complex
- [We Are Hiring: Associate Project Manager](https://flexdatabases.com/blog/we-are-hiring-associate-project-manager/) - Applications for this position are now closed and no longer being reviewed. 📍Required location: Prague 💼Associate Project Manager Flex Databases is looking for an Associate Project Manager to join our Customer Success Management team, based in our Prague office. While this role can be fully remote within Czechia, you must be available to visit the
- [How to move to post-Brexit pharmacovigilance effortlessly and efficiently](https://flexdatabases.com/blog/post-brexit-pharmacovigilance/) - In 2021 the United Kingdom is moving to its post-Brexit life with new processes, procedures, and laws everywhere, including clinical trials and pharmacovigilance. This piece we dedicate to a simple question – how to move to post-Brexit pharmacovigilance effortlessly and efficiently. All information in this article is based on Updated guidance on pharmacovigilance procedures published by Medicines
- [How to make sure that an eTMF is compliant to new TMF EMA Guideline?](https://flexdatabases.com/blog/how-to-make-sure-that-an-etmf-is-compliant-to-new-tmf-ema-guideline/) - 18th December 2018 EMA published a long-awaited “Guideline on the content, management and archiving on the clinical trial master file (paper and/or electronics)”. The release acquired many questions regarding the new reality of TMF, that everyone working in the EU will have to deal with after the document’s effective date 18/06/2019. How to make sure that
- [Flex Databases eTMF – easy collaboration with an unlimited number of sites at no added cost](https://flexdatabases.com/blog/easy-collaboration/) - Documenting everything is a burden when running a study, especially a big and international one. Just think about putting all the documents in one place, and, most importantly, keeping this place tidy and structured. One must collect documents from many sites and can’t allow losing anything. It usually costs a fortune to train site personnel
- [Managing multiple-currency studies with Flex Databases](https://flexdatabases.com/blog/multiple-currency/) - International clinical trials, in most cases, mean multiple currencies and exchange rates throughout all financial operations. Be it site or PI payments or transport and meal compensation for the patients; you will face the need to handle currency conversions in contracts and invoicing. Usually, everybody faces a lack of control and transparency when it comes
- [Streamline learning management of any scale with Flex Databases LMS](https://flexdatabases.com/blog/streamline-learning/) - When working in a regulated industry, learning management is a huge concern since the need to follow SOPs & complete training applies to all company employees (at different levels, but still). It’s complicated enough when we think of dozens of people split between dozens of roles, but what if it comes to hundreds or thousands?
- [Gateway to China](https://flexdatabases.com/blog/gateway-to-china/) - The drug regulatory authority of China – National Medical Product Administration (NMPA, formerly CFDA) has recently implemented a possibility to report Adverse Drug Reactions (ADR) through an XML-file submission. Flex Databases Pharmacovigilance system users are already able to do so. There are two general ways of reporting to the regulator – manual submissions through the website and
- [Tranquil Clinical Research selects Flex Databases CTMS and Pharmacovigilance](https://flexdatabases.com/blog/tranquil/) - United States-based Tranquil Clinical Research recently signed Flex Databases as a software provider for Clinical Trial Management System and Pharmacovigilance management solution. Tranquil’s ultimate goal is excellence in the clinical trial process and bringing trustworthy products to patients. Flex Databases CTMS and Pharmacovigilance system are well-known as unified yet flexible eClinical platform for full-cycle clinical trial management. It helps to
- [Metronomia Partners with Flex Databases for TMF Module to Support Biotech Client](https://flexdatabases.com/blog/metronomia-partners-with-flex-databases-for-tmf-module-to-support-biotech-client/) - Metronomia, a leading Data Management and Biostatistics CRO in EU, has selected Flex Databases' eTMF module to support one of its biotech clients. Simon Rückinger, Managing Director at Metronomia Clinical Research GmbH, explained their decision and what they expect from the partnership. "We needed a flexible and simple eTMF solution that could meet the specific
- [SCOPE Summit, 18 – 21 February, Orlando, Florida](https://flexdatabases.com/blog/scope-summit-18-21-february-orlando-florida/) - We’re excited to announce that we will begin our 2019 events with the upcoming 10th annual SCOPE Summit, 18 – 21 February in Orlando, Florida. As usual, we’re participating as exhibitors, so you can find us any day at booth #207! Evgenia Mikhalchuck, Director Business Development & Olga Sokolova, Director System Analysis will be happy to catch up
- [How we implemented eTMF & developed SOPs in 3 weeks for iRenix](https://flexdatabases.com/blog/how-we-implemented-etmf-developed-sops-in-3-weeks-for-irenix/) - Last year, right around this time, we implemented an eTMF for a California-based Medical Device company, iRenix. Our target? A swift 3-week completion, so everything was up and running before their FPI. Now, this is quite the sprint compared to the usual 5-6 weeks! And here’s the twist - while iRenix was laser-focused on their
- [SOLTI academic research group gets full transparency of clinical operations with Flex Databases CTMS and eTMF implementation](https://flexdatabases.com/blog/solti/) - As spring continues to bloom, we’re excited to announce our partnership with SOLTI, Spanish academic research group that performs clinical trials of excellence in oncology. With Flex Databases CTMS & eTMF implementation, SOLTI aims to perform detailed analysis based on the information included in the system, have an operational data repository easy to consult and
- [6 Ways To Improve Clinical Trials Management ](https://flexdatabases.com/blog/6-ways-to-improve-clinical-trials-management/) - Clinical trials play a crucial role in medical progress, yet effective management is essential to maximize their impact. Administrators must craft a thorough strategy to enhance how trials are managed. Here are five strategies to transform clinical trial management, providing administrators with the tools and insights needed to navigate healthcare research challenges effectively. Simplify planning
- [Metronomia selected Flex Databases to gain efficiencies in project management and budget-related activities](https://flexdatabases.com/blog/metronomia/) - This October, Metronomia Clinical Research GmbH chose Flex Databases as Project Management & Budgeting solution provider. Here’s how Metronomia’s team describes the new partnership: “We have been using Excel for many project management and budget-related activities so far. With an increasing number of projects and customers, this approach does not scale well and makes reporting
- [How to migrate data painlessly when switching to a new CTMS and eTMF](https://flexdatabases.com/blog/how-to-migrate-data-painlessly-when-switching-to-a-new-ctms-and-etmf/) - Recently, we discussed questions that might arise when changing your eClinical software provider. Today, we want to take a closer look at one of the most asked questions: How can I migrate data from a legacy CTMS or eTMF? Data migration is a delicate process with many moving parts. Without a well-established process, the CTMS go-live could
- [Flex Databases – your new powerful data house](https://flexdatabases.com/blog/powerful-data-house/) - What was always a problem? Every single person connected to clinical trials has always been dreaming to have one button to click Every person connected to clinical trials has always dreamed of having one button to click that could allow see all the information about the trial at once. Everybody dreamed about the place where
- [How to stop worrying and start working in clinical trials](https://flexdatabases.com/blog/how-to-stop-worrying-and-start-working-in-clinical-trials/) - A few months ago, I left my three years’ marketing job in the automotive industry and started a new exciting journey at Flex Databases, eClinical software developer. Hard start in the clinical research world I knew that clinical research is complicated from my interviews and some research, so I decided to start learning during my
- [Pharmacovigilance automation: components and levels](https://flexdatabases.com/blog/pharmacovigilance-automation/) - Modern pharmacovigilance, like any other process, in 2021 is impossible without technology and automation. The presence of an electronic system is a guarantee of high-quality and fast collection and processing of safety data. But even with an electronic system in place, it’s not possible to 100% avoid manual labor of collecting and entering data. But
- [Difference Between CDMS and CTMS](https://flexdatabases.com/blog/difference-between-cdms-and-ctms/) - Clinical Data Management Systems (CDMS) and Clinical Trial Management Systems (CTMS) are two key tools that play crucial roles in this process. While they might sound similar, they serve distinct purposes and offer different functionalities. What is a Clinical Data Management System (CDMS)? A Clinical Data Management System (CDMS) is a specialised tool designed to
- [Anything you can do, with DMS would be better – manager & user perspective](https://flexdatabases.com/blog/better-with-dms/) - Document management & storage is rarely considered as something complicated, however, it’s a backbone for everything. When it’s done wrong, you’ll experience process delays, incomplete or missing documents, and other data integrity & completeness issues. Flex Databases DMS is done exactly right – and here’s a quick overview of manager & user processes, that get
- [Client Spotlight: FGK Clinical Research GmbH CRO's Experience with Flex Database](https://flexdatabases.com/blog/client-spotlight-fgk-clinical-research-gmbh-cros-experience-with-flex-database/) - We had the pleasure of sitting down with Martin Krauss, Co-Founder and Managing Director of FGK CRO, to discuss how Flex Databases has supported their clinical research operations over the past 3.5 years.In this interview, Martin shares:• Why FGK CRO initially chose to partner with Flex Databases.• How our CTMS, TMF, and LMS solutions have transformed their
- [How Flex Databases Report Tool helps to get 100% of your data work](https://flexdatabases.com/blog/get-all-your-data-work/) - So, here’s the deal: with any data point in our system, you can make a report and visualize your data. And it’s free. And it takes just a few clicks to create. How it works: Step 1: Select data sources Any field in our system is a source You can pick as many as you
- [Top eTMF Features](https://flexdatabases.com/blog/top-etmf-features/) - Trial master files (TMFs) are essential for completing clinical studies, but managing TMF content can be very complex. Electronic trial master file (eTMF) systems represent the next step in clinical trial document management and are becoming an integral part of future clinical research. What is an eTMF? An electronic trial master file (eTMF) is a
- [AI validation for life sciences – a unique challenge of dynamic nature](https://flexdatabases.com/blog/ai-validation-basis/) - Let’s agree that in our regulated industry we take EXTRA cautious approach towards adopting new technologies. A standard validation approach of again standard computerized systems already includes the requirement for Installation Qualification (IQ) Design Qualification (DQ) Operational Qualification (OQ) and Performance Qualification (PQ) This is for standard all-time favorites – EDC, eTMF, CTMS, etc. But
- [How Novo Nordisk sped up payment process and cut costs with Flex Databases CTMS](https://flexdatabases.com/blog/novo-nordisk-flex-databases/) - About Novo Nordisk Novo Nordisk is a global healthcare company, founded in 1923 and headquartered just outside Copenhagen, Denmark. Their purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity, and rare blood and rare endocrine diseases. Project background Most trial sites are working with no more than a
- [Gouya Insights selected Flex Databases eTMF](https://flexdatabases.com/blog/gouya-insights/) - At the very beginning of March 2021, Flex Databases signed a contract for eTMF implementation with Austrian clinical industry experts’ company Gouya Insights. We’ve asked Gouya Insights CEO, Ghazaleh Gouya a couple of questions about the new partnership: Why Gouya Insights decided to pick Flex Databases as a provider for TMF module? Flex Databases was recommended by our
- [How to move from a paper TMF to Flex Databases eTMF in three steps](https://flexdatabases.com/blog/move-to-etmf-from-paper/) - One of the main factors stopping companies from moving to an eTMF is the actual moving process. When you think about transferring a ton of documents from paper to electronic, it usually seems to be just an impossible work. With Flex Databases eTMF all you need to move from paper to electronic Trial Master File is three
- [10 best clinical trial memes](https://flexdatabases.com/blog/10-best-clinical-trial-memes/) - We’ve selected our top-10 favorite memes about clinical trials industry – even though we all work in a serious environment, it never hurts to have fun once in a while. Also a hint for those, who want to know places to share a laugh with industry colleagues – check out Clinical Research Memes community on Facebook, we
- [eTMF FAQ - Frequently Asked Questions](https://flexdatabases.com/blog/etmf-frequently-asked-questions/) - What is an eTMF? An eTMF, or electronic Trial Master File, is a secure system used to manage all the essential documents and data for a clinical trial. It acts like a central library for everything related to the trial, from study protocols to investigator brochures. eTMF helps ensure everything is organized, easy to find,
- [CTMS 2022 – intelligence insights, not tools for automation](https://flexdatabases.com/blog/ctms-2022/) - Insights on what makes the most impact on the project. Instant full picture in one interface. Sense of full control. Clinical Trial Management System (CTMS) is one of the most popular and widely used eClinical software applications. It’s been on the market for decades, and from simple process management, the concept grew in many different directions.
- [Ultimate Guide to eTMF](https://flexdatabases.com/blog/ultimate-guide-to-electronic-trial-master-file/) - Even though electronic Trial Master File seems to be almost essential nowadays, there are still many questions on its value and benefits that it could bring to a company. We’ve decided to answer the most common and most important of them and walk you through the entire process – from Why select eTMF through Legacy data migration to Smart eTMF, which works
- [How to Implement Clinical Trial Management System?](https://flexdatabases.com/blog/how-to-implement-clinical-trial-management-system/) - A Clinical Trial Management System (CTMS) is software designed for the Life Science industry. It helps manage processes and handle substantial amounts of data related to clinical trial management and clinical study management. CTMS typically handles the planning, preparation, execution, and reporting of clinical trials. It focuses on maintaining updated contact information for participants and
- [Challenges in the Implementation of CTMS](https://flexdatabases.com/blog/challenges-in-the-implementation-of-ctms/) - Implementation of a Clinical Trial Management System (CTMS) can streamline operations, improve data management, and enhance trial oversight. However, the process also brings a range of challenges that must be addressed to achieve a successful implementation. These challenges often stem from technical and human factors, including data quality, system integration, and regulatory demands. Identifying these
- [How to Choose the Right eTMF System and Vendor](https://flexdatabases.com/blog/how-to-choose-the-right-etmf-system-and-vendor/) - Handling a Trial Master File (TMF) can be tough for clinical teams, but it doesn’t have to be. Old systems with outdated file sharing methods or homemade systems with spreadsheets or paper can make managing sensitive trial data risky. Over the past decade, electronic Trial Master File (eTMF) systems have helped many biopharma companies and
- [Flex Databases Product Updates: Enhanced TMF, PV, and More](https://flexdatabases.com/blog/flex-databases-product-updates-enhanced-tmf-pv-and-more/) - We’re excited to announce a series of updates across several modules of Flex Databases. From enhanced UI navigation to smarter automation and configuration options, these improvements are designed to streamline workflows and boost productivity across clinical operations. Trial Master File (TMF) Redesigned Project Configuration InterfaceWe’ve introduced a UX/UI enhancement to the Project Configuration section (Trial
- [Clinical Trials Trends and Insights in 2025](https://flexdatabases.com/blog/clinical-trials-trends-and-insights-in-2025/) - Clinical trials are evolving fast. In 2025, technology and smarter processes are reshaping how studies are run – making them faster, more efficient, and more patient-friendly. In this article, we’ll explore the trends you can’t afford to ignore: from the growing use of AI to stronger patient engagement, remote trial management, and a renewed focus
- [Product Updates: Smarter Planning, Cleaner Data, and Seamless Integration Across Modules](https://flexdatabases.com/blog/product-updates-may/) - We're excited to share the latest enhancements across multiple Flex Databases modules, all designed to improve your efficiency, reduce duplication, and support better data consistency throughout your clinical operations. CRA Activity Management: SDV Log Tracker To improve source data verification (SDV) oversight, we’ve introduced a new SDV Log Tracker. This tracker pulls data from Subject
- [Clinical trial memes](https://flexdatabases.com/blog/clinical-trial-memes/) - Clinical research is serious - but a little humor goes a long way. To celebrate International Clinical Trials Day, we’ve created a few memes that only researchers will truly appreciate. Because sometimes, laughter is the best medicine (after rigorous testing, of course).
- [How to Choose the Right eTMF Model](https://flexdatabases.com/blog/how-to-choose-the-right-etmf-model/) - An electronic Trial Master File plays a central role in maintaining oversight, ensuring regulatory compliance, and supporting successful inspections by health authorities. An efficient eTMF is no longer optional – it’s essential. Choosing the right eTMF model for your clinical studies directly impacts how effectively your teams can manage documentation, maintain version control, and collaborate
- [Flex Databases Product Updates - April](https://flexdatabases.com/blog/flex-databases-product-updates-april/) - Smarter, Safer, and More Automated – Feature Enhancements Across Project Catalogue, CRA Activity Management, Pharmacovigilance, ST&I, and API. Project Catalogue: Smarter Subject Tracking with Randomization Logic We’ve added a new toggle to project settings: “Randomization of the Project”. You can now define whether a project is Randomized or Non-Randomized, helping the system adapt how it
- [Case Study: SOLTI Streamlines Clinical Research with Flex Databases](https://flexdatabases.com/blog/case-study-solti-streamlines-clinical-research-with-flex-databases/) - About SOLTI SOLTI is a non-profit academic research group specializing in breast cancer clinical and translational research. Based in Barcelona, the group unites over 510 professionals across 113 hospitals, including oncologists, pathologists, radiologists, and study nurses. With 42 ongoing studies and a team of 60+ staff members, SOLTI supports clinical trials throughout their entire lifecycle
- [User Groups at Flex Databases: Where Feedback Meets Innovation](https://flexdatabases.com/blog/user-groups-at-flex-databases/) - At Flex Databases, we believe the best solutions are built together. That’s why we created Flex Databases User Groups - a unique meetings where our clients and their end-users come together to: Share real-world feedback and insights Discuss challenges and opportunities in clinical trials management Learn best practices from each other Preview upcoming product updates
- [We’re hiring: experienced eClinical Product Trainer at Flex Databases](https://flexdatabases.com/blog/were-hiring-eclinical-product-trainer/) - At Flex Databases, we’re on a mission to make a real impact in the Life Sciences industry with our CTMS, eTMF, and other systems for Life Sciences. Our platform supports Clinical Research Organizations and pharmaceutical companies across the globe in managing the complex world of clinical trials with greater clarity and efficiency. Now, we’re looking
- [Use Case: Saving Time and Cost with AI in TMF Document Management](https://flexdatabases.com/blog/use-case-ai-in-tmf-document-management/) - A mid-sized CRO managing 9,500 TMF documents annually faced increasing challenges with filing and metadata assignment. Each document required an average of 5–6 minutes to process manually. The Problem Manual document upload and metadata entry amounted to: 950 hours annually (based on 6 minutes per document) €47,500 in labor cost per year (at €50/hour average
- [Advancing Trial Master File Technology: Trends, Challenges, and Practical Applications in a Quality-Driven Era – Poster Session at CDISC TMF Europe Interchange!](https://flexdatabases.com/blog/advancing-trial-master-file-technology-presentation/) - Flex Databases is heading to Geneva on May 15–16! Visit our poster session presented by Marietta Sarkisian, Global Director of Business Development & Marketing, to explore how TMF technology is evolving to meet rising quality expectations in clinical trials. Let’s connect at #CDISCInterchange! Contact us at contact@flexdatabases.com
- [What Should You Look For in a CTMS?](https://flexdatabases.com/blog/what-should-you-look-for-in-a-ctms/) - Clinical trials are essential for developing new medical treatments, yet they often face challenges like complex protocols, regulatory compliance, and data management issues. Implementation of a Clinical Trial Management System (CTMS) can address these challenges by centralizing data, automating workflows, and ensuring compliance, thereby enhancing efficiency and reducing errors. The adoption of CTMS solutions is
- [Webinar recording - Digitalizing Clinical Trials: The Smarter Way to Run the Studies](https://flexdatabases.com/blog/webinar-recording-digitalizing-clinical-trials-the-smarter-way-to-run-the-studies/) - 📢 Missed our webinar?🎥 Watch the recording to see how SOLTI #cancerresearch streamlined trial management with Flex Databases! Our expert panel shares insights on CTMS selection, implementation, and daily use - plus a live mini-demo!In this session, we cover:🚀 Key triggers for adopting a CTMS📊 Lessons learned from the selection and migration process🔗 Real-world benefits
- [Webinar: Digitalizing Clinical Trials – The Smarter Way to Run the Studies](https://flexdatabases.com/blog/webinar-digitalizing-clinical-trials/) - 📅 Date: 20 March, 2025 ⏰ Time: 16:00 CET 🔗 Register now with just two clicks Join SOLTI and Flex Databases to discover how SOLTI transformed trial management, overcame challenges, and unlocked the full potential of digitalization. Our expert panel includes:🔹 Marietta Sarkisian - Global Director, Business Development, Flex Databases🔹 Lídice Vidal - Chief Clinical
- [How FGK CRO automated their clinical trials in 5 weeks](https://flexdatabases.com/blog/fgk-cro/) - At the very beginning of 2021 Flex Databases and German FGK CRO signed a contract for CTMS and eTMF implementation. About FGK FGK CRO is a full service contract research organization offering a complete range of clinical development and consulting services to pharmaceutical, biotechnology and medical device companies. FGK approaches each project, whether large or small, with dedicated, highly motivated, small
- [Clinical Research Glossary: Key Terms and Definitions](https://flexdatabases.com/blog/clinical-research-glossary/) - A Additive Effect - The combined effect when two or more things are used together. Adherence - Following the study directions and requirements. Adverse Event - A negative change or medical occurrence that happens during a clinical trial or within a certain time period after the trial has ended. An adverse event may or may
- [Flex Databases 2025 Conference Calendar: Meet Us Around the Globe](https://flexdatabases.com/blog/2025-conference-calendar/) - Join Flex Databases at key industry conferences throughout 2025! Our team will be attending major clinical research and life sciences events worldwide, ready to connect, share insights, and discuss how our platform can streamline your clinical trial management. Check out our event schedule and book a meeting with us at contact@flexdatabases.com. See you there!
- [How to Set Up an Effective QMS](https://flexdatabases.com/blog/how-to-set-up-an-effective-qms/) - Clinical trials provide essential information on the safety and effectiveness of drugs. Sponsors ensure that investigators follow protocols and collect and report quality data. Quality in clinical trials means that the product or service meets applicable regulations and customer requirements. A Quality Management System (QMS) in clinical research ensures compliance with ethical, regulatory, and GxP
- [Cloud-based CTMS vs. On-premises CTMS: Which is Right for Your Clinical Trial Management?](https://flexdatabases.com/blog/cloud-based-ctms-vs-on-premises-ctms-which-is-right-for-your-clinical-trial-management/) - Two popular models dominate the Clinical Trial management System landscape: Cloud-based and On-premises CTMS. Both have their merits, but choosing the right option depends on several factors, including cost, scalability, security, and operational requirements. This article will explore the differences between Cloud-based Clinical Trial Management System and on-premises CTMS, helping you determine which solution best
- [Exciting Updates: Enhancements to Our Platform!](https://flexdatabases.com/blog/updates-to-our-platform/) - We are thrilled to share several key enhancements that will streamline your workflows and improve data management. Enhanced Duplicates Search Our Duplicates Search feature has received a significant upgrade! The system now identifies 100% duplicate files from your Inbox by checksum, ensuring cleaner data management. When files are moved from the Inbox to any folder
- [FDA Releases Guidance on Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers](https://flexdatabases.com/blog/fda-guidance-september-2024/) - In October 2024, the U.S. Food and Drug Administration issued a final guidance titled Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers. https://www.fda.gov/media/166215/download This guidance provides recommendations on the use of electronic systems, electronic records and electronic signatures in food, medical product, tobacco product, and new animal drug clinical investigations.
- [Why Agenus Chose Flex Databases: A Client's Perspective](https://flexdatabases.com/blog/why-agenus-chose-flex-databases/) - October, 2024 – Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a strong pipeline of immune modulating antibodies, together with Flex Databases announce the successful implementation of Flex Databases' Clinical Trial Management System (CTMS) and electronic Trial Master File (eTMF) solutions, including a new AI-driven feature for automated document filing and metadata assignment. This partnership
- [Webinar Recording: Quality Digitalization with Deloitte](https://flexdatabases.com/blog/webinar-recording-quality-digitalization-with-deloitte/) - Did you miss our recent webinar on Quality Digitalization? The recording is now available! In this insightful session, Anna Petrovskaya, QA Director at Flex Databases, and Vera Valesova, PhD, Senior Manager at Deloitte, explore the critical aspects of transforming your QMS into a digital solution. Key topics covered: How to successfully digitalize your QMS Achieving
- [Meet us at BIO-Europe!](https://flexdatabases.com/blog/meet-us-at-bio-europe/) - We’re excited to announce that Flex Databases will be participating in this prestigious event from November 4–6, 2024. Join us to explore our innovative solutions!Connect with Kristina Kojoushko at the event to learn more about our services, including eTMF, CTMS, Pharmacovigilance Software and more.📅 Schedule a meeting with Kristina at kristina.kojoushko@flexdatabases.com or reach out to
- [October User Group Meeting Recap: New eTMF Features, Client Feedback, and Future Plans](https://flexdatabases.com/blog/october-user-group-meeting-recap-new-etmf-features-client-feedback-and-future-plans/) - A new round of our traditional meetings took place in October. This time, we gathered our beloved users to discuss the use of eTMF - from everyday activities to audit preparation. We reviewed how newly released features, such as duplicate search, quality review, and metadata notifications, influence TMF workflows. It appeared not everyone was using
- [How to Choose Pharmacovigilance (PV) Software for Clinical Trial Management](https://flexdatabases.com/blog/how-to-choose-pharmacovigilance-software/) - Pharmacovigilance (PV) is a critical aspect of drug safety, focusing on detecting, assessing, understanding, and preventing adverse drug reactions or other drug-related problems. As global regulatory requirements for drug safety evolve, adopting reliable pharmacovigilance software has become essential for ensuring compliance and improving operational efficiency. Selecting the right PV software can significantly impact your organization's
- [The Future of AI in TMF](https://flexdatabases.com/blog/the-future-of-ai-in-tmf/) - The Trial Master File (TMF) is the cornerstone of clinical trial documentation, serving as the definitive record of compliance with regulatory standards and ethical guidelines. Yet, the management of TMFs has grown increasingly complex with the rise in document volume, diversity, and stringent compliance requirements. Artificial intelligence (AI) is poised to address these challenges, introducing
- [Flex Databases Achieves ISO 27001 Certification](https://flexdatabases.com/blog/flex-databases-achieves-iso-27001-certification/) - We’re pleased to announce that Flex Databases’ IT security measures are now formally certified under ISO 27001. This certification, earned after a thorough audit, demonstrates that our systems meet internationally recognized standards for information security. ISO 27001 sets requirements for managing sensitive company and customer data securely. By achieving this milestone, we assure our clients
- [Enhancements to Investigators & Sites Management and Trial Master File](https://flexdatabases.com/blog/enhancements-to-ism-and-tmf/) - At Flex Databases, we are committed to delivering cutting-edge solutions that streamline clinical trial management. Our latest updates bring powerful enhancements to the Investigators & Sites Management module and Trial Master File, helping users gain better insights, improve workflows, and ensure seamless compliance. Investigators & Sites Management: Stay Ahead with a Powerful Dashboard Our newly
- [Maximize Efficiency with the Data Deletion Tool](https://flexdatabases.com/blog/data-deletion-tool/) - The Data Deletion Application is an advanced tool that helps organizations manage storage, meet regulations, and improve data security. It allows secure removal of entire studies from Trial Master File storage, giving businesses full control over sensitive information. Key Benefits Free Up Storage Space: to remove outdated or unnecessary data, ensuring your system remains optimized
- [eTMF to arrange your Quality Review of Folder Completeness ](https://flexdatabases.com/blog/quality-review-folder-completeness/) - It’s been out for some time now - Quality Review in eTMF of Flex Databases. But though we started with document review initially we expended this feature to folder completeness review capabilities. Key Benefits of the Folder Completeness Review Track Folder Completeness: Monitor the status of folders throughout the review process. Assess Document Quality: Ensure
- [Palobiofarma Chooses Flex Databases for Pharmacovigilance Management ](https://flexdatabases.com/blog/palo-biofarma-chooses-flex-databases-for-pharmacovigilance-management/) - Palobiofarma is a leading clinical-stage biotech company dedicated to developing innovative medicines. Our focus on adenosine signaling drives our commitment to scientific excellence, with six drug candidates currently in different phases of development. Among them, PBF-999 for Prader-Willi Syndrome stands out as a key project. Our mission is to advance patient care by leveraging cutting-edge
- [Enhancing TMF Efficiency with the New Duplicates Search Feature](https://flexdatabases.com/blog/enhancing-tmf-efficiency-with-the-new-duplicates-search-feature/) - At Flex Databases, we continuously improve our Trial Master File system to enhance compliance, efficiency, and user experience. Our latest update introduces an advanced Duplicates Search Feature, streamlining document management and ensuring data integrity. Introducing the Duplicates Search Feature The Duplicates Search Feature helps users identify and manage duplicate files within the TMF. It prevents
- [Streamlined Document Management with Linked Files](https://flexdatabases.com/blog/streamlined-document-management-with-linked-files/) - To simplify this process of documents efficiently management across multiple clinical projects Flex Databases introduces the Linked File feature, a powerful solution that centralizes document storage, streamlines updates, and enhances compliance. Key Features Flex Databases' Linked Files feature centralizes key documents, connecting them to multiple projects. This eliminates the problems of managing document copies. It
- [How Flex Databases’ QMS Aligns with ICH E6(R3) GCP Guidelines](https://flexdatabases.com/blog/how-flex-databases-qms-aligns-with-ich-e6r3-gcp-guidelines/) - On January 14, 2025, the International Council for Harmonisation (ICH) took a major step forward in clinical trials management with the release of the updated E6(R3) Good Clinical Practice (GCP) guidelines. This milestone reflects the industry's commitment to enhancing the quality, reliability, and compliance of clinical research. At Flex Databases, we’re proud to offer a
- [Flex Databases Certified to ISO 9001:2015](https://flexdatabases.com/blog/flex-databases-certified-to-iso-90012015/) - We've always been proud of our Quality Management System, which has been recognized by our clients during numerous audits and has helped us become a trusted vendor to regulated companies all over the world. Now, we have documented evidence - the ISO 9001:2015 certificate. Flex Databases' ISO 9001:2015 certification demonstrates its dedication to providing a
- [CRA Activity Management – your processes, but digital](https://flexdatabases.com/blog/your-processes-digital/) - Digitalization, or moving to a new software provider for whatever reasons usually comes together with resistance. You don’t want to change your processes, since there are a lot of employees to get on board with the change. However, you still want transparency, performance analysis, and all those benefits of having an electronic system in place
- [User-centric CTMS. C-level, Manager or a CRA? Have we guessed your needs?](https://flexdatabases.com/blog/user-centric-ctms/) - When we build a product, we base its core on the challenges our customers may face and how to solve them. We step in your shoes to see things from your point of view – what you need. Here’s the list of challenges that you have, and we solve – and how exactly we solve
- [6 main concerns about changing your eClinical software provider](https://flexdatabases.com/blog/6-concerns/) - Changing your software provider is a massive burden since there were already many resources invested into picking your current one, implementation, etc. We talk to potential clients nearly 24/7 and 365, and we’ve heard all the concerns and troubles that exist. So, here is a six-step checklist of the most prevalent concerns before changing a software provider
- [Flex Databases Recognized as a Top Clinical Trial Management Provider for 2024](https://flexdatabases.com/blog/flex-databases-recognized-as-a-top-clinical-trial-management-provider-for-2024/) - We are excited to share that Flex Databases has been named a Top Clinical Management Provider for 2024 by Life Science Review. This prestigious recognition highlights our strong reputation and the trust placed in us by both customers and industry peers, reflected in numerous nominations from Life Science Review subscribers. Flex-Databases_CertificateDownload This award comes at
- [Why customers value Flex Databases?](https://flexdatabases.com/blog/value/) - We solve problems We don’t show you cookie-cutter presentations, we solve your problems with our flexible platform. We bring transparency Systems provide you a real complete picture of what is going on with your trials at any given moment. Flex Reporting tool allows you to track any KPIs across departments, projects, countries, etc. We have a full-stack
- [The Use of AI in eTMF](https://flexdatabases.com/blog/the-use-of-ai-in-etmf/) - While AI might sound futuristic, its role in document management is simply the next step in automation. Imagine a system that automatically files the documents and assigns relevant metadata. This is now possible with Flex Databases’ AI-powered solution. But before we delve deeper, let's address a key point: AI is not a magic bullet. It's
- [Product Updates: December, 2024](https://flexdatabases.com/blog/product-updates-december-2024/) - We are excited to announce several new features and improvements to Flex Databases’ modules. These updates aim to streamline workflows, enhance usability, and improve overall efficiency for our users. Here's an overview of the latest developments and their benefits. Trial Master File (TMF) Duplicates Search: Files Content Comparison Path: Trial Master File → (open project)
- [How Clinical Trial Sites Can Meet Sponsor Expectations in 2025](https://flexdatabases.com/blog/how-clinical-trial-sites-can-meet-sponsor-expectations-in-2025/) - Clinical trials are becoming more complex every year, and sponsors are raising the bar for what they expect from sites. They want faster processes, more accurate data, and better ways to keep patients engaged - all while staying compliant with ever-evolving regulations. As we look ahead to 2025, these demands will only grow. New technologies
- [2019 Round-up](https://flexdatabases.com/blog/2019-roundup/)
- [Clinical trials software vendor selection process](https://flexdatabases.com/blog/vendor-selection/) - At DIA 2019 Yvonne Lungershausen, CEO Avance Clinical, and Evgenia Mikhalchuk, Director, Business Development & Marketing Flex Databases discussed with PharmaVoice how Avance Clinical performed vendor selection for CTMS and TMF and why they chose Flex Databases. Watch the full interview (5 min.) to know more!
- [A2 Healthcare Taiwan Corporation chose Flex Databases CTMS & TMF](https://flexdatabases.com/blog/a2tw-flexdbs/) - A2 Healthcare Taiwan Corporation (A2TW) has recently adopted Flex Databases CTMS and TMF solutions. A2TW team comments that they decided to implement the system to improve clinical trial quality, compete with global CROs and simplify cross-countries studies processes. Via Flex Databases, A2TW can manage clinical trials with less time and human resource to get more accuracy, real-time controlled and visual reports.
- [Sourcia selects Flex Databases as eTMF provider](https://flexdatabases.com/blog/sourcia/) - Sourcia, a full-service European CRO, has recently signed a contract for electronic Trial Master File implementation with Flex Databases. We’ve asked Claudia Gruber, Director Clinical Operations a couple of questions about the upcoming partnership: Why has Sourcia decided to pick Flex Databases as an eTMF provider? CG: To foster and allow for our continued growth,
- [Recording: AI in eTMF - Auto-Classification and Metadata: Efficiency and Compliance](https://flexdatabases.com/blog/recording-ai-in-etmf-joint-with-deloitte/) - Have questions about AI in eTMF? This is the perfect opportunity to get them answered. You can now take a picture of a document with your phone, email it to eTMF, or drag and drop a document into eTMF, and it will be automatically filed in the correct place with automatically added metadata. Embracing innovation,
- [Strategies for Effective Site Selection and Management in Clinical Trials](https://flexdatabases.com/blog/strategies-for-effective-site-selection-and-management-in-clinical-trials/) - Effective site selection and management are critical components of successful clinical trials. Choosing the right locations and overseeing their operations can significantly impact the trial's timeline, budget, and ultimately, its success in delivering reliable data. This article explores essential strategies for optimizing site selection and management, highlighting key considerations, practical tips, and the role of
- [Top 10 Benefits of Modern CTMS for CRO’s](https://flexdatabases.com/blog/top-10-benefits-of-modern-ctms-for-cros/) - Clinical Research Organizations (CROs) operate in a dynamic industry where efficiency and adaptability are critical. As the global clinical trials market expands significantly, with forecasts predicting substantial growth, CROs face increasing demands to manage multiple trials efficiently across diverse projects and stakeholders. Legacy systems, still prevalent among CROs according to recent surveys, often fall short
- [Revolutionizing Document Management: How AI Transforms Trial Master Files](https://flexdatabases.com/blog/revolutionizing-document-management-how-ai-transforms-trial-master-files/) - In today's busy world of clinical research, managing documents efficiently is crucial. Imagine being able to organize hundreds of documents in just minutes. Here’s how Flex Databases’ AI-powered Trial Master File (TMF) system makes this possible. From Chaos to Order in a Few Clicks The process is remarkably simple. Users can drag and drop a
- [Join us at the 11th Annual OCT UK and Ireland 2024](https://flexdatabases.com/blog/join-us-at-the-11th-annual-oct-uk-and-ireland-2024/) - Attending the 11th Annual Outsourcing in Clinical Trials UK and Ireland 2024? We’ll be there too! We’re thrilled to announce that Flex Databases will be participating in this prestigious event. Join us at the London Hilton on Park Lane, UK, from June 11-12. Connect with Evgenia Michalchuk-Vrablik at the event to explore our comprehensive solutions,
- [Quality Over Quantity: Optimizing Clinical Research with an Effective QMS Strategy Databases](https://flexdatabases.com/blog/optimizing-clinical-research-with-an-effective-qms-strategy-databases/) - Quality management in clinical research is crucial to ensure the integrity, reliability, and validity of the data collected. This process encompasses all activities that ensure the study is conducted in compliance with regulatory requirements, guidelines, and best practices. Adding QMS strategy databases in your organization can help your processes by miles. For one, implementing a
- [Why Calian chooses Flex Databases as eClinical Provider](https://flexdatabases.com/blog/why-calian-chooses-flex-databases-as-eclinical-provider/) - Calian expects Flex Databases to streamline their clinical trials by centralizing data, reducing manual work, and improving overall efficiency. This will lead to faster trials and better-quality information. The implementation of Flex Databases will improve Calian’s oversight capabilities and provide a single source of truth for their studies. This forward-looking approach ensures their ability to
- [BIO US 2024](https://flexdatabases.com/blog/bio-us-2024/) - Planning to attend BIO US? We are, too!We're excited to share that Flex Databases will be participating in BIO US 2024, a premier event for the biopharma industry. Join us at the San Diego Convention Center, California, from June 3-6 📅.Connect with Matija Sokic at the event to explore our comprehensive solutions, including eTMF, CTMS,
- [Meet us at QA Virtual Conference hosted by RQA](https://flexdatabases.com/blog/meet-us-at-qa-virtual-conference-hosted-by-rqa/) - On May 21, Anna Petrovskaya, our QA Director, will be delivering a speech titled "AI-supported TMF: Validation and other Challenges" at the International QA Virtual Conference hosted by RQA. This annual event, which we eagerly attend every year, is taking place on May 21st and 22nd, 2024, under the theme 'Back to the Future of
- [14th Annual Outsourcing in Clinical Trials Europe 2024](https://flexdatabases.com/blog/14th-annual-outsourcing-in-clinical-trials-europe-2024/) - We are excited to announce Flex Databases' participation at the 14th Annual Outsourcing in Clinical Trials Europe 2024, taking place on May 7-8 in Barcelona, Spain. We invite you to meet our team members and watch Evgenia Michalčuk-Vráblík, Global Director of Growth, giving a talk on "AI in eTMF – Auto-Classification and Metadata | Efficiency
- [Stallergenes Greer Chooses Flex Databases eTMF to Enhance Inspection Readiness and Oversight Efforts](https://flexdatabases.com/blog/stallergenes-greer-chooses-flex-databases-etmf/) - Stallergenes Greer, a global healthcare company specializing in allergy diagnosis and treatment through allergy immunotherapy (AIT) products, has chosen Flex Databases as its eTMF vendor. The answers were provided by Virginie Lobrégat-Duriez, Director of Clinical Operations, and Dominique Jouny, Senior Clinical Project Manager. Q1. What did Stallergenes Greer have to start looking for an eTMF
- [Webinar with Deloitte | AI in eTMF – Auto-Classification and Metadata: Efficiency and Compliance](https://flexdatabases.com/blog/webinar-with-deloitte-ai-in-etmf-auto-classification-and-metadata-efficiency-and-compliance/) - Join us for an exclusive insightful webinar as we explore Artificial Intelligence (AI) within the Electronic Trial Master File (eTMF) system. Explore how AI can transform document management, simplify processes, and maintain compliance with regulatory standards. What to Expect? First-hand experience: Demo of automated filing of documents and metadata assignment in the eTMF system by
- [Deloitte and Flex Databases forge strategic alliance to drive digitalisation in Life Sciences across Europe](https://flexdatabases.com/blog/alliance-deloitte/) - Deloitte, a renowned leader in professional consulting, and Flex Databases, a trailblazer in flexible electronic systems, have officially announced their strategic alliance, signed at the end of year 2023. This collaboration is set to transform the Life Sciences sector by leveraging Deloitte’s expertise in process management, validation, onboarding, and consulting, alongside Flex Databases’ state-of-the-art electronic
- [TMF Quality Review 2.0 ](https://flexdatabases.com/blog/etmf-quality-review/) - Periodic TMF reviews automatically documented. Quality and completeness under control! Let's address an intriguing issue in the clinical trial landscape. It appears that while one third of sponsors are less than satisfied with the quality of clinical trials, an overwhelming 90% of CROs are confident in their high-quality delivery. The solution might lie in implementing
- [Archiving eTMF for 25 years? Secure, accessible, and compliant with Flex Databases ](https://flexdatabases.com/blog/25-years-tmf-archiving/) - Good Clinical Practice guidelines require clinical trial documents to be kept for at least two years after the last marketing application approval in an ICH region. These documents may need to be stored longer if regulations or the sponsor require it. The EU Clinical Trial Regulation (CTR) 536/2014 demands that the content of the clinical
- [Webinar recording: Digitalizing Quality Management System: How and Why? with Deloitte](https://flexdatabases.com/blog/deloitte-webinar-recording/) - Late November we've hosted a joint webinar with Deloitte on how you can and why you should consider digitalizing Quality Management System. A joint webinar on quality digitalization with Vera Valesova, PhD, Senior Manager at Deloitte Risk Advisory/Life Science&Healthcare unit. Vera joins the stage together with our QA Director, Anna Petrovskaya, a well-recognized quality professional
- [Webinar with Deloitte: Digitalizing Quality Management System: How and Why?](https://flexdatabases.com/blog/qms-webinar-deloitte/) - November 21st, 17.00 CET we'll have a joint webinar on quality digitalization with Vera Valesova, PhD, Senior Manager at Deloitte Risk Advisory/Life Science&Healthcare unit. Vera will join the stage with our QA Director, Anna Petrovskaya, a well-recognized quality professional and RQA speaker. Here are the main questions that Anna and Vera are going to cover
- [11th Annual OCT Nordics 2023](https://flexdatabases.com/blog/oct-nordics/) - We're excited to announce our participation in 11th Annual Outsourcing In Clinical Trials Nordics 2023, October 24 – 25, Copenhagen, Denmark. Not only can you meet our brilliant team members during the event, but also encounter a chance to hear Evgenia Michalčuk-Vráblík, Global Director of Growth, give a talk titled "Seamless Digital Collaboration: Uniting Vendors
- [KPI reports – get a complete overview of what's essential at a glance](https://flexdatabases.com/blog/kpi-reports/) - Nowadays, there's no such thing as too much optimization in team or process management. That's why we decided to get you another step ahead with our KPI reports – multi-component reports that'll help you focus everything essential on one screen. We'll look at Site Initiation and Enrollment reports for today's exercise. In one report, you
- [WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management](https://flexdatabases.com/blog/wsg/) - Earlier this summer, WSG - Westdeutsche Studiengruppe GmbH selected Flex Databases as a CTMS and eTMF provider. We’ve asked Michael Städele, Director, Business Development & Operations a couple of questions about the new partnership: Why WSG decided to implement eTMF and Investigators & Sites Management modules? What was the starting point for digitalization? Over the
- [DIA 2023: key takeaways of the event](https://flexdatabases.com/blog/dia-2023-key-takeaways/) - As always, DIA 2023 was mostly about the people we meet & talk to, but there is a big second value to it – the talks, the ideas and insights that we get during the conference. Let's take a look at what's hot in Boston! Embracing Technology: The conference highlighted the use of technology in
- [Flex Databases is a member of CRISI initiative](https://flexdatabases.com/blog/crisi/) - We always say that integration of the systems is one of the keys to success. That’s why we pay a lot of attention to API at Flex Databases. Flex Databases has become a member of CRISI – The Clinical Research Interoperability Standards Initiative, developing a comprehensive library of standard APIs. We are proud to be
- [The No-Code approach to clinical trial management: LifeScience Review interview](https://flexdatabases.com/blog/the-no-code-approach-to-clinical-trial-management/) - Our BD&Marketing Director Evgenia Michalčuk-Vráblík has recently set down with LifeScience Review reporter to talk about the No-Code approach that Flex Databases is leading in CTMS world and how it benefits our client's business operations. The interview followed the reward that Flex Databases received as one of Top-10 CTMS providers in 2023. While maintaining compliance,
- [RWE-ready eTMF for 24/7 transparency in your documents](https://flexdatabases.com/blog/rwe-ready-etmf/) - As we all know, the eTMF structure for RWE studies differs from a general TMF Reference Model. Here's the list of main differences: To make everyone's lives easier, we added a template for RWS to our eTMF – you can select it when you create an eTMF structure for the project from the list of
- [How to stay a 100% compliant in a changing regulatory landscape, validation POV](https://flexdatabases.com/blog/how-to-stay-complian/) - There are some eternal values in regulated companies' lives: GCP, 21 CFR Part 11, and computerized systems validation. However, even these are subject to change. Recently the most important of them have been updated: And we can add the well-acknowledged guidance to this list: GAMP®5: 2021 Good Practice Guide: Enabling Innovation. The changed regulations do
- [Webinar recording: Speed-up patient recruitment by the means of automated site payments](https://flexdatabases.com/blog/speed-up-patient-recruitment/) - On the first day of June we've hosted a joint webinar with our client, Confidence Pharmaceutical Research. Agenda: – Why site payments are an essential part of study management– How the site payment process works at Confidence Pharmaceutical Research/ Lifehacks of Confidence Pharmaceutical Research: how to speed up site payments in real life– More case studies:
- [5 examples of data sets that are shared between Flex Databases CTMS & eTMF](https://flexdatabases.com/blog/5-examples-data-share-ctms-etmf/) - A study published in the Journal of Medical Systems found that integrating eTMF and CTMS systems resulted in a 50% reduction in the time required to identify missing documents and a 75% reduction in the time required to resolve missing document issues. Flex Databases CTMS & eTMF are interconnected to deliver you the highest possible
- [Move from a legacy system to Flex Databases in 6 simple steps](https://flexdatabases.com/blog/from-legacy-to-flex-6-steps/) - Digitalization is complicated not only the first time you go for it, but also when the moment for change comes. When we are a bit too dependant on a software provider, it may seem like there's no way out, or data migration too much to handle – and it could be a blocker to consider
- [A simple way to speed up site payments & grow site engagement](https://flexdatabases.com/blog/speed-up-site-payments/) - How long does paying to the sites while running a clinical trial take you? Average figures usually range from 4 to 6 months, even though in the contract, the payment period would typically be a month. Will you get frustrated if you are paid with a half-year delay? Yeah! Will that motivate you to work
- [Five ways in which clinical study can benefit from having CTMS in place](https://flexdatabases.com/blog/5-ctms-benefits-clinical-study/) - “Why did you decide to implement CTMS?” is one of the first questions our CTMS clients get during a presale. We’ve collected top-5 answers for you to check and see if something hits close to home, and it’s time to start thinking about your own CTMS implementation. Here they are: Efficient study start-up: CTMS helps
- [Webinar recording: Digitalizing Quality Management System: how and why?](https://flexdatabases.com/blog/qms-webinar-recording/) - In early April 2023 we've hosted a webinar about why and how you can digitalize your Quality Management System with our brilliant QA Director Anna Petrovskaya as a host. To learn more about Flex Databases QMS, please visit our product page or request a demo via form on top of the page or a request
- [SocraTec R&D selected Flex Databases eTMF to make essential documents available in real-time globally and tighten co-operations](https://flexdatabases.com/blog/socratec/) - Earlier this year SocraTec R&D, a CRO from Germany, selected Flex Databases as an eTMF vendor. We asked CEO André Warnke a couple of questions about the upcoming partnership: Why SocraTec R&D decided to implement Flex Databases eTMF? As full service CRO with all kind of clients from small/mid-sized companies to globally operating corporations, SocraTec
- [Flex Databases compliance checklist for EMA Guideline on computerised systems and electronic data in clinical trials](https://flexdatabases.com/blog/flex-databases-compliance-checklist-for-ema-guideline/) - Early March 2023, EMA has finalised and published the updated Guideline on computerised systems and electronic data in clinical trials. Here's how we approach compliance to Guideline requirements: To read the full guideline, click
- [Manage multi-lingual cases within a single instance with Flex Databases Pharmacovigilance](https://flexdatabases.com/blog/multi-lingual-pv/) - If you operate globally, you must comply with local language requirements, which also apply to pharmacovigilance reporting. Imagine that you must manage cases & report in English, Spanish, and French. How would you do that? The apparent answer many providers usually offer is multiple inputs of the same cases. Drop that! With Flex Databases Pharmacovigilance,
- [Challenges of bringing an international team together: an employee point of view](https://flexdatabases.com/blog/bring-international-team-together/) - As we grow not only by numbers but also by the number of different nationalities in our company, we focus more on our internal cross-cultural communication processes. Sometimes we are all very different, and it is true, but we are all the same when it comes to delivering the best result and fostering eco-communication at
- [Three big questions AI helps to answer in drug development process](https://flexdatabases.com/blog/ai-drug-development/) - There are three big questions in any industry, including pharmaceuticals & clinical trials: How to save time? How to save money? How to improve the quality? Artificial intelligence is one of the new answers to all of them. Here are a few examples: When it comes to saving time, AI is here to take over
- [Configurable QMS to stay on top of your quality processes](https://flexdatabases.com/blog/configurable-qms/) - Implementing Quality Management System might be a struggle. You have it perfect on paper, but you must comply with the harsh reality of your software vendor’s system logic. Well, it’s not a problem anymore with Flex Databases QMS. In our most recent update, we’ve made every process within QMS fully configurable. You get the LEGO blocks
- [iRenix Medical implements Flex Databases eTMF to achieve compliance with key regulations & support multi-center clinical trials](https://flexdatabases.com/blog/irenix/) - We’re excited to announce a new client – a US-based biotech iRenix Medical. Earlier this year, iRenix team selected Flex Databases as an eTMF provider. We’ve asked Stephen J. Smith, MD, Founder and CEO at iRenix Medical a couple of questions about the upcoming partnership: Why iRenix Medical decided to implement eTMF module? What was the
- [Meet us at SCOPE 2023](https://flexdatabases.com/blog/scope-2023/) - We're excited to kick-off events of 2023 by visiting SCOPE 2023 in Orlando, the US. To meet with our one and only Business Development Director Evgenia Michalčuk-Vráblík and Product Director Vlad Kolbatov, simply step by our booth #728. Can't wait to meet you all!
- [Anima Research Center selects Flex Databases LMS & QMS to maintain & improve high level of quality](https://flexdatabases.com/blog/anima-research/) - We’re starting our 2023 with some great news about a new client – Belgian Anima Research Center selected Flex Databases as a LMS & QMS provider. We have asked Linde Buntinx, Chief Development Officer at Anima, a couple of questions about the upcoming partnership: Why ANIMA Research Center decided to implement LMS & QMS? What
- [Flex Databases launches Innovation Unit at Teknokent Antalya](https://flexdatabases.com/blog/innovation-unit/) - Flex Databases launches Innovation Unit within Teknokent Antalya to further develop advanced solution for data-informed decisions in drug development. We’ve ended 2022 on a high note – by being accepted into Teknokent Antalya as residents with our Innovation Unit. Flex Databases Innovation Unit aims to further develop our Powerful Datahouse to address the needs of
- [Five criteria to consider when looking for an EDC](https://flexdatabases.com/blog/5-criteria-edc/) - Software selection and assessment is a complicated and sometimes confusing process, especially if you have to pick a provider in a hurry or if it's your first time doing so. We've gathered a short list of mandatory criteria for you to check out – and have an excellent start to your EDC selection journey. Functionality
- [Clinergy Health Research selects Flex Databases Pharmacovigilance as cost-effective and easy to integrate solution](https://flexdatabases.com/blog/clinergy/) - Clinergy Health Research recently selected Flex Databases as Pharmacovigilance software provider. We’ve asked Suyh Lin, Clinical Project Manager at Clinergy Health Research a couple of questions about the upcoming partnership: Why Clinergy Health Research decided to implement PV? What was the starting point for digitalization? PV system and digitalization was implemented due to one of our client's
- [Move from spending on FTE to saving with routine automation with Flex Databases CTMS](https://flexdatabases.com/blog/save-with-flex-databases-ctms/) - Clinical trials, as everything else in the world, is undergoing a heavy shift to process digitalization and automation. It has its ups and downs, but the future looks bright – we can minimize human error, optimize, and automate our processes and save money. Today we’ll talk about how exactly you can move from spending money
- [Answering top-6 questions about milestones](https://flexdatabases.com/blog/6-questions-milestones/) - We kept six main questions in mind during the development of milestones. Do you want to know the answers? Milestones – why bother? Milestones help us to: meet the deadlines, allocate time to each specific task of the trial, raise the visibility of the study in general. Plus, milestones demonstrate the trial's success and completion
- [Webinar: Actionable milestones to connect & control project performance throughout CTMS & eTMF](https://flexdatabases.com/blog/webinar-milestones/) - November 17th, 2022 at 17.00 CET we’ll be hosting a webinar about actionable milestones that you can use to connect & control project performance throughout the Flex Databases system, including CTMS & eTMF. Connected milestones simplify control & assessment of project performance and provide you with a full transparent picture of it. Webinar host: Mountacer Benyahya, Customer
- [How to adjust eTMF to your processes in 4 simple steps using flexible workflow](https://flexdatabases.com/blog/etmf-flexible-workfl/) - New software implementation is an imminent part of any digitalisation, but it does not come easy: out-of-the-box solutions are usually built with an average consumer in mind. It would tick the necessary and important boxes, but other than that you usually must adjust and shift your processes and procedures to it. At Flex Databases, we
- [Flex Databases recognised as one of top-10 Pharmacovigilance providers in the UK & Europe](https://flexdatabases.com/blog/flex-databases-top-pharmacovigilance-uk-europe/) - This September, Pharma Tech Outlook included Flex Databases in Top-10 Pharmacovigilance solutions providers in the UK & Europe. Our Business Development & Marketing Director Evgenia Mikhalchuk took part in a cover story for Pharma Tech Outlook September'22 issue, supporting our nomination: Clinical trials have always been about data. But, prior to automation, data input was
- [We're excited to share the schedule of events that our brilliant Business Development Managers will be attending this Autumn:](https://flexdatabases.com/blog/autumn-2022-events/) - BIO Europe, Leipzig, October 24 – 26 CHPI Worldwide, Frankfurt, November 1 – 3 Clinical Trials Europe, Amsterdam, November 7 – 9 Send a meeting request to bd@flexdatabases.com and seh dich später!
- [How to set up eTMF quality checks in three simple steps](https://flexdatabases.com/blog/etmf-quality-checks/) - The difference between a paper Trial Master File and an electronic one is not only the storage and availability of documents. eTMF allows you to stay on top of your documentation in terms of quality – and here’s an instruction on how to set up Quality Checks in Flex Databases eTMF. In Flex Databased eTMF,
- [SPARC chose Flex Databases as one solution with an increased possibilities of integration after vetting 11 vendors](https://flexdatabases.com/blog/sparc/) - Earlier this year Sun Pharma Advanced Research Company (SPARC) selected Flex Databases to be a full-scale eClinical vendor, purchasing eTMF, CTMS and Project Management & Budgeting solutions. We've asked Maya Bhattacharya, Manager-I Business Continuity (Implementation Lead) a couple of questions about the upcoming partnership: Why SPARC decided to implement eTMF, CTMS and PM&B? What was
- [A land before time: how LMS enables your QA and Training teams to save time and be ready for any audit](https://flexdatabases.com/blog/save-time-qa-routine-lms/) - Do you remember when each new SOP or an update of an SOP required your QA and Training Teams to send out the emails to the employees? The days when everybody had to print and sign the acknowledgment forms? And then, the poor QA and Training Teams were to file the forms manually. It seems
- [Minimising human error in clinical study with Flex Databases CRA Activity Management](https://flexdatabases.com/blog/minimise-human-error/) - In clinical trials, any mistake can cost you a whole study. That's why one of the essential things in the studies is processes and procedures. But what's the first emotion you get about these words? Let me guess: disappointment, fear, irritation? It is probably connected to the fact that processes and procedures almost never work
- [AXIS Clinicals selected Flex Databases CTMS & eTMF to streamline service areas](https://flexdatabases.com/blog/axis-clinicals/) - This summer AXIS Clinicals chose Flex Databases as a CTMS & eTMF software provider. We’ve asked Melissa Burgard, MSW, CCRC, Director, Clinical Research and Dinkar Sindhu, Chief Executive Officer at AXIS Clinicals a few questions about the upcoming collaboration: Why Axis decided to implement CTMS and eTMF? AXIS is implementing CTMS as we see this
- [Five things we've loved about DIA Annual Meeting 2022](https://flexdatabases.com/blog/five-things-about-dia2022/) - We celebrated an important date this year – 10 years since our first DIA Annual Meeting exhibition. Many things have changed, but the important thing has stayed the same – DIA Annual Meeting is a fantastic place to meet like-minded people, make new connections, and reconnect with old friends. We'd love to thank the event's
- [Site Health Assessment as a part of Risk-Based Monitoring](https://flexdatabases.com/blog/sha-flex-ctms/) - Risk-Based Monitoring (RBM) has become one of the trends in clinical trials of the last decade. Sponsors and regulatory authorities recognize RBM as an efficient approach to ensuring patient safety and data quality. We always keep track of market trends and develop features that facilitate our clients' needs in implementing RBM techniques. What is Site
- [What makes Flex Databases truly flexible?](https://flexdatabases.com/blog/flexible-flex/) - Flexibility is the signature quality of Flex Databases. To showcase it, we've put together four cornerstones of What makes Flex Databases truly flexible. Request a demo through the form or message us to bd@flexdatabases.com to learn more
- [Report Tool 2.0 – creating reports is as easy as making your morning coffee](https://flexdatabases.com/blog/report-tool-2-0/) - Every user of eClinical solutions faces the need for a fast and effective assessment of different kinds of information. Flex Databases Report Tool 2.0 is the best way to get that. Get the answers you need without asking too many questions – simply pick the source data you need, and the system will take care
- [Video: The way we save time on case intake in Flex Databases Pharmacovigilance module](https://flexdatabases.com/blog/pv-case-intake/) - In this video we talk about the way Flex Databases Pharmacovigilance module helps to save time on case intake. Video Duration: 03:28
- [Meet us at DIA Annual Meeting 2022](https://flexdatabases.com/blog/dia-2022/) - The travel season for 2022 is on – and this time we meet in Chicago, our kind of town. Our best of the best will be attending DIA Annual Meeting 2022 – Evgenia Mikhalchuk, Director, Business Development & Marketing, Vlad Kolbatov, Product Director & Natalia Blagodarova, Director, Operations. To meet those fine people you could
- [Data integrity assessment according to ALCOA++: Flex Databases eTMF is fully compliant](https://flexdatabases.com/blog/alcoa-compliance/) - Data integrity has always been a critical point during the development of eTMF systems. One of the industry's latest standards is ALCOA++, and our eTMF module is 100% compliant with ALCOA++. Let's see what advantages it brings to our clients. A – Attributable In our eTMF module, all actions conducted with each item are caught,
- [eClinical solutions as a major means of inter companies' communication in Clinical Trials](https://flexdatabases.com/blog/eclinical-communications/) - Are you the only one who needs access to the system? In clinical trials, we often need to collaborate with a lot of partners for each trial or sometimes even to execute different tasks. And the more partners we have – the more difficult it appears to manage all the processes. Moreover, many people think
- [QA Director of Flex Databases to speak at Virtual European QA Congress 2022](https://flexdatabases.com/blog/virtual-european-qa-2022/) - Our QA Director Anna Petrovskaya will attend Virtual European QA Congress 2022, organised by the RQA, as a speaker. Date: 11.05.2015 Topic: What is the Audit Trail for the Auditor? Time: 14:00 You can find more detail and book your ticket here.
- [Answering 6 most frequently asked questions about Flex Databases Pharmacovigilance module](https://flexdatabases.com/blog/6-faq-pv/) - Each step of Flex Databases is always done with one thought in mind – to save time and money for our clients. That's why to save your time and give you a deeper understanding of how our Pharmacovigilance module work, we are happy to answer the six most frequently asked questions about the system. How
- [Ultimate guide to CTMS](https://flexdatabases.com/blog/ctms-guide/) - Clinical Trial Management System (CTMS) is an essential tool for any modern company, engaged in clinical trial process somehow. We've decided to compile an Ultimate Guide about Flex Databases CTMS and answer the biggest questions a person could have on the subject: from what is CTMS to what's coming next. Table of contents: Chapter 1:
- [Simplify data migration with our new tool – Data Import Wizard](https://flexdatabases.com/blog/data-import-wizard__trashed/) - We have constantly been developing our eClinical solutions keeping simplicity as one of our products' core values. At the same time, we strive to implement new tools that make our clients' lives easier and the processes faster. It is a significant issue when migrating to a new system, and this fact pushed our developers to
- [Nutrasource selects Flex Databases to cover the entire clinical trial lifecycle with a single solution](https://flexdatabases.com/blog/nutrasource/) - At the very beginning of 2022, Canadian CRO Nutrasource selected Flex Databases as an eClinical provider to cover the entire clinical trial lifecycle with a single solution. “‘We are looking forward to the efficiencies that will be gained across our team with the implementation of Flex Databases allowing us to move to an single solution where we
- [Meet us at SCOPE 2022: 7-10 February 2022, Orlando](https://flexdatabases.com/blog/scope-2022/) - We are extremely excited to announce that we start off 2022 with an offline event – SCOPE 2022! Evgenia Mikhalchuk, Director, Business Development & Marketing, and Vladimir Kolbatov, Product Director, will be there for you at booth #215. To schedule a demo or any other meeting prior to the event, please, message us at bd@flexdatabases.com After all
- [How to never miss a thing about your eTMF documents](https://flexdatabases.com/blog/etmf-chat/) - Have you ever missed a last-minute change in the file you’re working with? Do you lose track of thousands of messaging apps and emails? Do document review bugs you by being distributed into many channels, that you must align together? It’s not a problem anymore! With eTMF chat in Flex Databases eTMF everything, that you
- [Software validation in clinical trials industry](https://flexdatabases.com/blog/eclinical-software-validation/) - Here’s the plan for the video: • What’s validation and why it is needed • Validation flow • What documents should a regulated company have after validation? • What Flex Databases provides and covers • What is left for a client to cover and how we can help • Clients’ feedback about Flex Databases validation
- [System Owner – a key to successful system implementation](https://flexdatabases.com/blog/system-owner/) - The system owner is the client’s employee responsible for the overall implementation and operation of a clinical trial management system on the client’s side. It is a primary contact for us as a vendor and a driver of change in the company. In this video, we discuss the role of the system owner, necessary skills and background,
- [BioClever selected Flex Databases eTMF and PM & Budgeting ](https://flexdatabases.com/blog/bioclever/) - This fall BioClever, Spanish full-service CRO, and Flex Databases signed a contract for eTMF, Project Management & Budgeting and Time Sheets & Utilization implementation. We’ve asked Jordi Cantoni, Director at BioClever a couple of questions about the new partnership: Why BioClever decided to implement eTMF, Project Management & Budgeting, Time Sheets & Utilization? The main reason to decide
- [eClinical software implementation – Flex Databases way](https://flexdatabases.com/blog/implementation-video/) - We can deliver a fully functional system in the timeframe from 3 to 10 (typically around 5) weeks, depending on the Client’s involvement and the complexity of the Client’s requirements. This video is an overview of how the implementation process goes. Timecodes: 00:09 About Flex Databases 00:20 Plan for this video 00:26 Typical implementation scope 00:41 Flex Databases implementation
- [eClinical software pricing – common way vs. Flex Databases way](https://flexdatabases.com/blog/eclinical-software-pricing/) - What are the components of a typical eClinical software pricing and how do we at Flex Databases approach it? Here’s an answer. Timecodes: 00:14 About Flex Databases 00:26 Plan for this video 00:36 Typical budget structure for SaaS eClinical system 01:37 Flex Databases cost structure 02:39 What if I need a new function or customization? 03:01 Ideas Lab 03:38 How we grow
- [Managing resources of your clinical trial projects the right way](https://flexdatabases.com/blog/managing-resources-of-your-clinical-trial-projects-the-right-way/) - As the business grows, it becomes critical to learn how to manage resources efficiently. Using Excel spreadsheets to track the utilization of available resources is no longer an option, especially if your company expands globally or conducts sophisticated projects with a lot of data points. Resource utilization allows you to monitor resources at your disposal and
- [Flex Databases Quality Management System – 1 system for 100% compliance](https://flexdatabases.com/blog/qms/) - Quality Assurance is an essential part of any clinical research-related business. We built Flex Databases QMS module based on industry standards, latest trends, AND personal experience. A significant share of our employees is from QA departments of global CROs and have previous quality-related work experience. Audit calendar & reporting There’s a massive amount of internal and external
- [CTMS & eTMF implementation – Flex Databases & FGK CRO case study](https://flexdatabases.com/blog/fgk-video/) - In this video, we’ll tell you about Flex Databases CTMS & eTMF implementation for FGK CRO. We’ve reviewed the case study before, you can find the text version here. Timecodes:00:19 About Flex Databases00:46 VIdeo plan01:00 About FGK CRO01:44 Project Scope02:00 Project timeline: Preparation stage02:30 QA environment02:54 Production delivery03:15 Feedback from the client03:54 Contact us
- [QA Director of Flex Databases to speak at 2021 international QA Conference](https://flexdatabases.com/blog/rqa2021/) - Our QA Director, Anna Petrovskaya, will attend #RQA2021 as a speaker. Date: 03.11.2021 Time: 19:30 Theme: Vendors Input into Computer System Validation Due to travel complications during the pandemic, Anna will be a part of the Virtual Meet the Exhibitors event. You can find out more detail and book your ticket at the RQA website. The Research Quality Association
- [Challenges of pharmacovigilance automation](https://flexdatabases.com/blog/https-flexdatabases-com-blog-challenges-of-pharmacovigilance-automation/) - The development of information technology is significantly ahead of the development of regulatory and other legislation. Despite the obvious benefits of introducing new technologies in electronic systems for pharmacovigilance, it is necessary to consider the difficulties that a company will face: Validation and audits completion New approaches need to be developed to ensure quality, pass
- [Using Artificial Intelligence in Pharmacovigilance](https://flexdatabases.com/blog/using-artificial-intelligence-in-pharmacovigilance/) - As we briefly discussed in the previous chapter, Artificial Intelligence (AI) is used to simulate the processes of a human brain with the help of computer systems. It encompasses various technologies, including rule-following, reasoning – using rules to reach rough or specific conclusions, learning, and self-correction. Implementation areas of AI In the area of pharmacovigilance
- [Solving site payments problem with Flex Databases Subject Tracking & Invoicing](https://flexdatabases.com/blog/site-payments-problem/) - st trial sites work with no more than a 3-month operating budget. With an estimated two-thirds of trial sites falling into this category, software companies have sought to close this gap in effective financial operations with process automation and payment schedule. So CROs, pharma companies, and biotech can finally get transparency in site payments. Likewise, effective
- [Faron selected Flex Databases eTMF to have better oversight for Faron sponsored studies](https://flexdatabases.com/blog/faron/) - This summer Flex Databases and Faron, a Finnish biopharmaceutical company, signed a contract for eTMF implementation. We’ve asked Maria Lahtinen, Director, Supplier Management at Faron, a couple of questions about the new partnership: Why Faron decided to implement eTMF? What was the starting point for digitalization? Faron had two aims for the project – to have
- [Flex Databases Platform: Interface Overview](https://flexdatabases.com/blog/platform-interface-overview/) - Clinical Trial Management System (CTMS) Manage all your CRA activities, patients’ data, sites, and invoicing in real time. Schedule monitor visits, assess CRA performance, and generate any type of visit reports. Set up online invoicing, payment rules, and different site budgets. Organize all the information on investigators, sites, vendors, therapeutic areas in one place. Project
- [10 years of Flex Databases](https://flexdatabases.com/blog/10-years-of-flex-databases/) - It all started with a big bang small team of professionals aiming to build a masterpiece of a product and a company. Now we are almost a hundred, and it couldn’t have been better. Product 10 years of Flex Databases System development in six steps: We went from 6 to 12 modules in 10 years, and it’s
- [ABX-CRO selects Flex Databases CTMS and eTMF](https://flexdatabases.com/blog/abx-cro-ctms-and-etmf/) - This summer ABX-CRO and Flex Databases signed a contract for a CTMS & eTMF implementation. We asked Dr. Ulrike Schorr-Neufing, Director, Qualification & Training, ABX-CRO, a couple of questions about the upcoming partnership. Why ABX-CRO decided to pick Flex Databases as a provider? After an intensive selection and evaluation process comparing different service providers ABX-CRO
- [How do we make validation simple and speed up implementation up to 2 times](https://flexdatabases.com/blog/simple-validation/) - Software validation is tricky, especially for those who’s never met it before. Still, it Is required, and it can affect implementation timelines in the worst way if handled poorly. That’s why we at Flex Databases developed a simple workflow to make validation almost effortless and as simple as possible: Step 1: We provide the happy new
- [What’s new: Flex Databases Release 12](https://flexdatabases.com/blog/release-12/) - We constantly update and develop our system to meet clients’ expectations and provide the most advanced and user-friendly system for their needs. Here’s what’s new in Flex Databases Application Release 12. Common functionality Mass assignment for Project catalogue: Assigning process becomes faster – just select employees and add them to projects and sites in bulk,
- [Exom Group implements Flex Databases CTMS and Pharmacovigilance](https://flexdatabases.com/blog/exom-group/) - At the very end of winter, Flex Databases signed a contract for CTMS and Pharmacovigilance module implementation with Italian Human & Digital CRO Exom Group. We’ve asked Luigi Visani, MD, President & CEO at Exom Group a couple of questions about the upcoming partnership: Why did Exom Group decide to pick Flex Databases as a provider? “Since its inception,
- [Why Australia and Flex Databases are perfect for early phase clinical trials](https://flexdatabases.com/blog/australia-early-phase-trials/) - When industry experts talk about the role of Australia in worldwide clinical trials, many mention its perfect fit for early phase trials conduction. Despite the noticeable remoteness, the country has many advantages to offer for clinical trial sponsors all over the world. Let’s outline the biggest of them and see, why Flex Databases is a
- [What’s next for Flex Databases Learning Management System?](https://flexdatabases.com/blog/whatsnext-lms/) - It’s been two years since our How to stop worrying and start working in clinical trials material dropped. Content-wise, it was the highest point for our Learning Management System so far. I have to admit, since then, we kind of abandoned its storytelling activities and just sometimes briefly mentioned new developments for LMS in our release notes.
- [TCD chose Flex Databases eTMF](https://flexdatabases.com/blog/tcd-chose-flex-databases-etmf/) - At the end of 2020 TCD, an African-focused CRO with a full-service offering, signed a contract for eTMF implementation with Flex Databases. We’ve asked Bianca Oelschig, Clinical Data Sciences Manager/Project Manager at TCD, a couple of questions about the upcoming partnership: Why TCD decided to pick Flex Databases as a provider for eTMF? After spending many months researching
- [Flex Databases CTMS – Subject Tracking & Invoicing](https://flexdatabases.com/blog/sti-video/) - Subject Tracking & Invoicing – Flex Databases CTMS module. Use Subject Tracking & Invoicing Module to track all patients’ data and manage invoicing online. Plan and schedule patient visits efficiently. Video duration: 08:50
- [Happy Holidays!](https://flexdatabases.com/blog/2020holidays/) - Thank you for being with us 2020,We wish you a happy and healthy 2021. Some of you (well, considering that it’s the 29th of December and most of us are on holidays, most of you) will read this text in 2021 and know a little bit more about a year ahead, but there’s one thing
- [Flex Scan App](https://flexdatabases.com/blog/flex-scan-app/) - We keep making users’ lives easier! At least for early adopters. Don’t you have your mobile phone on you all the time? It’s the only thing you need to upload scanned documents into our eTMF. No more broken scanners or bad connection – just take pictures on the go and spend your time on more important tasks.
- [Flex Databases Project Management & Budgeting](https://flexdatabases.com/blog/full-cycle-solution/) - When we think about project management & budgeting systems, we usually imagine something with a bad interface, no clear user logic, and an overloaded price. Well, there is something on the market that’s easy to understand and use yet still powerful, flexible, and doesn’t cost like a new jet. Since 2011 we develop and improve
- [Introducing Ideas Lab: a place where your ideas become our goals](https://flexdatabases.com/blog/ideas-lab/) - Flex Databases system is well-known for its flexibility (you get it right from our name). We continuously develop our system and add new functionality. To create a roadmap, we follow clients’ requests to stay flexible, customer-driven, and relevant. But where our clients’ ideas go? How do we make sure that nothing important is lost and
- [PureCDM selects Flex Databases](https://flexdatabases.com/blog/purecdm/) - Australian data management service provider PureCDM has recently signed a contract with Flex Databases to implement our Project Management & Budgeting and Time Sheets & Utilization solutions. We’ve asked Helen Poliviou, Managing Director a couple of questions about the upcoming partnership: Why did PureCDM decide to pick Flex Databases as a Project Management & Budgeting, Time Sheets & Utilization provider? With
- [Bionical Emas selects Flex Databases baseline CTMS](https://flexdatabases.com/blog/bionical-emas/) - Bionical Emas is the only CRO to combine Clinical Development, Early Access Programs and Clinical Trial Supply, to deliver a unique, seamless approach supporting our clients to bring new medicines to patients faster. “Our partnership relationships are paramount to everything that we do, and we work closely with our clients to become an extended part of their team. We
- [API or not-API: integration capabilities of Flex Databases system](https://flexdatabases.com/blog/integration/) - Even though Flex Databases system allows our clients to cover all software needs within one platform, there are cases when the company needs to integrate existing providers with the new ones. We understand the need entirely, and that is why we offer several ways to integrate with basically any system or solution that supports integration.
- [Meet us at BioPharm America 21-24 September 2020](https://flexdatabases.com/blog/biopharm-2020/) - It’s been a while since we last announced participation in an event! Flex Databases will participate in BioPharm America on 21-24 September 2020. This year the event will be delivered digitally. You can schedule a meeting or a live system demo with Evgenia Mikhalchuk, Business Development & Marketing Director, through the partnering system or simply send a
- [What’s next for eTMF](https://flexdatabases.com/blog/whats-next-etmf/) - Electronic Trial Master file (eTMF) – one of the must-have software solutions for a pharmaceutical company or a CRO nowadays. Almost any company either already has one implemented or thinking about it (and if you are – check out our how-to article on moving from paper to eTMF!) As everything, eTMF concept develops with time, moving
- [Assign DMB implements Flex Databases CTMS, eTMF & PV](https://flexdatabases.com/blog/assign-dmb/) - This June Assign Data Management and Biostatistics – Assign DMB chose Flex Databases as a provider for CTMS, eTMF, and Pharmacovigilance management systems. We’ve asked Dr. Anton Klingler, CEO Assign DMB and Mag. Sabine Haid, Lead Project Manager, a few questions about the upcoming partnership: Why Assign DMB decided to pick Flex Databases as a provider for
- [Flex Databases CTMS – Investigators & Sites Management](https://flexdatabases.com/blog/ism-video/) - Investigators & Sites Management – Flex Databases CTMS module. Investigators & Sites Management Module helps to organize all information on investigators, sites, vendors, therapeutic areas, IRB/LECs, etc. It provides easy search capability for feasibility assessments and other needs. Video duration: 06:25
- [Happy Clinical Trials Day!](https://flexdatabases.com/blog/clinicaltrialsday20/) - Today is the day, dedicated to all of us who work in clinical trials – International Clinical Trials Day. Even though we are parted physically, for now, we are all together grateful for being a part of the industry. We praise the braveness and tirelessness of everyone, who is investing their precious time into finding
- [How eTMF saves money](https://flexdatabases.com/blog/etmf-saves-money/) - When we ask our clients why they’ve decided to implement one or another system, among many reasons, we always have something budget-related – it might be financial transparency, cost-effectiveness, and other variations. Financial transparency is a big subject that we will cover soon in a separate article, but today is for cost-effectiveness. Four ways how Flex
- [How we’ve moved to remote: challenges, solutions and findings](https://flexdatabases.com/blog/move-to-remote/) - Over a month ago, we at Flex Databases moved our employees to work from home due to a pandemic outbreak. We have met challenges, part of which are solved, and some are still ongoing. The situation is going to develop further, but the time has come to take a deep breath and review where we
- [What’s new in Flex Databases Application Release 11](https://flexdatabases.com/blog/release-11/) - Trial Master File 6.0 OCR recognition: Upload scanned documents and pictures in TMF and make them searchable. System supports automatic text recognition on upload or single file recognition in more than 8 languages Digital sign-off function for documents: assign authors, reviewers, and approvers, upload documents for digital sign-off. The system creates a document with a
- [Trial Master File: paper vs eTMF](https://flexdatabases.com/blog/paper-vs-etmf/) - Electronic Trial Master File or eTMF is not a new thing on the market, yet there are still companies working with paper solutions. Of course, every single eTMF provider now has a “Now it’s time to change to eTMF because it’s online” kind of article, but we at Flex Databases believe, that eTMF is more than just
- [FDA has released the Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 pandemic](https://flexdatabases.com/blog/fda-covid-19/) - Yesterday morning FDA has released the Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 pandemic. Here are the parts of Guideline recommendations that may be successfully followed with Flex Databases system: Protocol deviations and IRBs/IEC submissions tracking The Guideline states, that “FDA recognizes that protocol modifications may be required and that there may
- [How CRA Activity Management impacts daily life of a CRA](https://flexdatabases.com/blog/how-cra-activity-management-impacts-daily-life-of-a-cra/) - If we imagine clinical trials as a human body, Clinical Research Associates would be the blood cells. They travel a lot across the whole organism, delivering data oxygen to all organs and body parts. If something stops the proper functioning, it may result in global failure. That’s the reason why we developed CRA Activity Management module –
- [Signal management is now free](https://flexdatabases.com/blog/signal-management-is-now-free/) - Flex Databases Signal Management tool in Pharmacovigilance module utilizes modern qualitative and quantitative (statistical, machine learning, neural network) methods to detect signals more precisely. And, from now on, it is provided for free for all Pharmacovigilance module buyers. Request a demo via the button on top of the page to know more!
- [How Flex Databases CTMS and TMF help optimize clinical trials processes](https://flexdatabases.com/blog/how-ctms-tmf-optimize-processes/) - Clinical trials are known for being extremely expensive and complicated, yet some right tools can make things easier – a tool like Flex Databases system, for example. Here’s how: CTMS: Flex Databases CTMS is a single point for management of all clinical trial components, including project management, monitoring activities, sites management, and payments. There’s no
- [Flex Databases Application Release 10: What’s new](https://flexdatabases.com/blog/release10-whatsnew/) - HR Database Ability to set up external users access and hide/unhide whole modules for different classes of users. Investigators and Sites Management System Ability to use free text format in site number. CRA Activity Management Offline capability: user now can fill in questionnaire offline and then upload it into the System Connection to the Trial
- [Flex Databases Events – November 2019](https://flexdatabases.com/blog/november19-events/) - November 2019 is going to be a busy events month for us at Flex Databases as we are going to visit three conferences: Evgenia Mikhalchuk, Director, Business Development & Marketing, and Ekaterina Borisenko, Business Development Associate will attend CPhI Europe November 5-7 in Frankfurt, Germany Kristina Kozhushko, Business Development Manager, will visit BIO Europe November 11-13 in Hamburg, Germany
- [Flex Databases at ESMO congress – Barcelona, September 27 – October 1](https://flexdatabases.com/blog/esmo-2019/) - We are excited to announce our participation in the upcoming ESMO congress, September 27 – October 1 in Barcelona, Spain. Meet with Evgenia Mikhalchuk, Director, Business Development & Marketing, she will be happy to catch up and tell you about our system. To plan a meeting drop us a line at bd@flexdatabases.com
- [Where will be my Data Center?](https://flexdatabases.com/blog/where-will-be-my-data-center/) - We have a list of prequalified Data Centers according to our SOPs as we have clients all over the world, location of servers and backups are agreed and reflected in the Service Level Agreement. Due to many territory and regulations-specific requirements, there’s one question we always get from our new customers: Where will be my
- [Flex Databases CTMS – CRA Activity Management](https://flexdatabases.com/blog/craam-video/) - CRA Activity Management – Flex Databases CTMS system module. Effective Management of all CRA activities. Let the system manage timelines and support you in your daily performance. Schedule monitor visits, track action items, assess CRA performance based on various KPIs, and generate any type of monitoring visit reports (PSV, SIV, IMV, COV) within CRA Activity Management
- [How Technology is Revolutionizing eClinical Platforms](https://flexdatabases.com/blog/how-technology-is-revolutionizing-eclinical-platforms/) - An academic article published on npj Digital Medicine shows that mobile technologies like smartphones, smartwatches, implantables, and similar are becoming more ubiquitous in clinical research. Sixty-seven percent of these technologies were categorized as wearable sensors. This can only mean that technological adoption in the healthcare sector is high because they make it easier for researchers
- [Flex Databases at DIA 2019 Global Annual Meeting in San Diego, June 23 – 27](https://flexdatabases.com/blog/dia-2019/) - We’re so excited (we just can’t hide it) to announce our participation in DIA 2019 Global Annual Meeting in San Diego! Step by booth #1037 to learn more about our system. Evgenia Mikhalchuk, Director, Business Development & Marketing, and Kristina Kozhushko, Business Development Manager, will be happy to catch up and show you a quick demo.
- [TOP-5 things to do in Philadelphia](https://flexdatabases.com/blog/top-5-things-to-do-in-philadelphia/) - BIO 2019 is approaching at Philadelphia, PA. If you are planning to visit – here’s our little guide! Since most of us are clinical trials professionals, and we have some deep feelings for medicine-related things, the first place we recommend is The Mütter Museum. Medical history tells itself from a different perspective of medical abnormalities,
- [Game of Clinical Trials](https://flexdatabases.com/blog/game-of-clinical-trials/) - Pick up your emblem and motto and join us in the never-ending process of making new safe and efficient drugs to save the world!
- [DIA China 2019 – May 20-23, Beijing](https://flexdatabases.com/blog/diachina-2019/) - We are excited to announce our participation in the upcoming 2019 DIA China Annual Meeting, 20-23 May 2019 in Beijing, China. Meet with Evgenia Mikhalchuk, Director, Business Development & Marketing, and Vladimir Kolbatov, Product Manager, they will be happy to catch up and tell you about our system. To plan a meeting drop us a
- [World Backup Day – March 31st!](https://flexdatabases.com/blog/world-backup-day-march-31st/) - March 31st is important for every data related human – World Backup Day. World Backup Day was established by enthusiasts to remind everyone about the importance of keeping personal data safe. enters at a geographically different location within the same region as the primary data center, with the same level of physical and infrastructure security described above, to
- [Shared vendor audit to save resources? Why not?](https://flexdatabases.com/blog/shared-vendor-audit-to-save-resources-why-not-2/) - e clinical trials are extraordinarily expensive and addendum to ICH GCP E6 R2 recommends to “encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording and reporting”, as well as to use risk-based approach when planning the activities in clinical trials, industry must move forward and utilize efficient procedures in any possible
- [The scope of the #SCOPE2019](https://flexdatabases.com/blog/the-scope-of-the-scope2019/) - 10th Annual SCOPE Summit was held on 18 – 21 February in Orlando, Florida. If you have missed it for any reason, we are here to fill you in! Usually, all the insights we gather through an event are of two kinds: current industry problems and upcoming trends. This time we begin with Problems. Main
- [Essentials of ICH GCP E6 R2: infographic](https://flexdatabases.com/blog/essentials-of-ich-gcp-e6-r2-infographic/) - Good Clinical Practice is not only an industry standard – it is one of the core documents of our company, all of our modules are made in accordance with GCP. Interested? Request a demo via form on top of the page or drop us an e-mail to bd@flexdatabases.com
- [SCOPE Summit Europe, October 16-17, Barcelona](https://flexdatabases.com/blog/scope-summit-europe-october-16-17-barcelona/) - We are excited to announce our participation as exhibitors in the upcoming SCOPE Summit Europe, 16-17 October 2018 in Barcelona, Spain. Evgenia Mikhalchuk, Director Business Development, will be happy to catch up and show you the system. Step by our booth #4 to see our platform in action and learn more about Flex Databases! To plan a meeting drop
- [GDPR is here and Flex Databases got your back!](https://flexdatabases.com/blog/gdpr-is-here-and-flex-databases-got-your-back/) - Flex Databases is always ready to support you in any challenging situation. And today, when GDPR came into effect, we are here to demonstrate that with us you are fully prepared to it in terms of our partnership. Here are some key GDPR requirements with explanation on how Flex Databases meet them: GDPR: Article 28.2 ‘The processor
- [10th DIA China Annual Meeting, May 23-25, Beijing](https://flexdatabases.com/blog/10th-dia-china-annual-meeting-may-23-25-beijing/) - We are excited to announce our participation in the upcoming 10th DIA China Annual Meeting, 23-25 May 2018 in Beijing, China. Meet with Olga Loginovskaya, MD, Chief Quality & Corporate Officer, and Timur Galimov, Chief Technology Officer, they will be happy to catch up and show you the system. To plan a meeting drop us
- [Site Payment Problems and Solution](https://flexdatabases.com/blog/site-payment-problems-and-solution/) - Clinical Trials are notoriously expensive to operate, with the majority of trial sites working with no more than a 3-month operating budget. That means that maintaining up-to-date financial records, and responsibly using what funds do exist is more essential than ever before. With an estimated two-thirds of trial sites falling into this category, software companies
- [DIA 2018, June 24-28, Boston](https://flexdatabases.com/blog/dia-2018-june-24-28-boston/) - The DIA 2018 Annual Meeting is one of the largest and longest running events in the life sciences industry. Step by our booth #1438 to see our platform in action and learn more about Flex Databases! To plan a meeting drop us a line at bd@flexdatabases.com
- [Top eTMF Audit Expectations and Preparation Strategies that Matter](https://flexdatabases.com/blog/top-etmf-audit-expectations-and-preparation-strategies-that-matter/) - With so many CROs switching to an entirely digital format for their Trial Master Files, the legislators in charge of the regulations which govern compliance with international GCP standards are being forced to adapt as well. The nature of these changes has been conducive to simplifying and fortifying the entire auditing process, not only making
- [4th European Conference on Clinical Research, February 26-27 2018, Vienna](https://flexdatabases.com/blog/4th-european-conference-on-clinical-research-february-26-27-2018-vienna/) - We are excited to announce our participation in the upcoming 4th European Conference on Clinical Research, February 26-27 2018, Vienna. Meet with Evgenia Mikhalchuk, Director Business Development, she will be happy to catch up and show you around the system. To plan a meeting drop us a line at bd@flexdatabases.com
- [SCOPE Summit, 12-15 February, Orlando, Florida](https://flexdatabases.com/blog/scope-summit-12-15-february-orlando-florida/) - We are excited to announce our participation as exhibitors in the upcoming SCOPE Summit, 12-15 February 2018 in Orlando, Florida. Meet with Olga Loginovskaya, MD, Chief Quality & Corporate Officer, and Evgenia Mikhalchuk, Director Business Development, they will be happy to catch up and show you around the system. To plan a meeting drop us a
- [Keeping Critical Data Safe and Accessible Using eTMF Technology](https://flexdatabases.com/blog/keeping-critical-data-safe-and-accessible-using-etmf-technology/) - In an age where nearly a hundred percent of your clinical research organization’s data can be stored using paperless resources and the number of cloud based solutions on the market has become significantly larger, the electronic trial master file has emerged as one of the most relevant new developments in the world of clinical research
- [CROWN Congress, Philadelphia, January 23-25](https://flexdatabases.com/blog/crown-congress-philadelphia-january-23-25/) - Flex Databases is the official sponsor of the CROWN Congress, January 23-25, 2018, an elite gathering of clinical decision-makers challenge the status quo and discuss innovative approaches and strategies to optimize clinical operations as the industry evolves. Evgenia Mikhalchuk, Director of Business Development and Natalia Blagodarova, QA Department Director, will be happy to catch up and show
- [Flex Databases training for Novo Nordisk](https://flexdatabases.com/blog/flex-databases-training-for-novo-nordisk/) - Last week Timur Galimov, our Chief Technology Officer, and Olga Sokolova, System Analysis Director, conducted a 2-day training for our client Novo Nordisk, a global healthcare company with more than 90 years history of innovation and leadership in diabetes care. Flex Databases team walked Novo Nordisk team through the system, demonstrated functionality peculiarities. The system
- [Flex Databases Simplifies Access to Clinical Trial Software with Single Sign-On Function](https://flexdatabases.com/blog/flex-databases-simplifies-access-to-clinical-trial-software-with-single-sign-on-function/) - Nowadays site teams and project teams are required to quickly access, gain proficiency in and use different online software applications to execute their roles in clinical trials studies. It takes some real efforts to memorize or document many web addresses, usernames and passwords along with the growth of automation, efficiency and quality. Furthermore, system administrators
- [Partnerships in Clinical Trials Europe, 28-29 November, Amsterdam](https://flexdatabases.com/blog/partnerships-in-clinical-trials-europe-28-29-november-amsterdam/) - We are excited to announce our participation in the upcoming Partnerships in Clinical Trials Europe, 28-29 November 2017, Amsterdam. Meet with Olga Loginovskaya, MD, Chief Quality & Corporate Officer, and Evgenia Mikhalchuk, Director Business Development, they will be happy to catch up and show you around the system. To plan a meeting drop us a line
- [DIA Annual Meeting, Chicago, IL, 18-22 June, Booth #2044](https://flexdatabases.com/blog/dia-annual-meeting-chicago-il-18-22-june-booth-2044/) - The DIA 2017 Annual Meeting is one of the largest and longestrunning event in the life sciences industry. Step by our booth 2044 to see our platform in action and learn more about Flex Databases! Step by our booth #2044 to see our platform in action! To plan a meeting drop us a line at bd@flexdatabases.com
- [Clinical Trials Innovation Summit, Boston, MA, 24-26 April](https://flexdatabases.com/blog/clinical-trials-innovation-summit-boston-ma-24-26-april/) - We are excited to announce our participation in the upcoming Clinical Trials Innovation Summit, 24-26 April, Boston, MA. Step by our booth #12 and join ‘Contracting Strategies for Today’s Clinical Trials’ panel discussion. Natalia Romashkina, Head of Project Management Office at Flex Databases, will perform as a speaker and share her expert opinion on trends in ‘Pharma-CRO-Sites’contract development,
- [CROWN Congress, Philadelphia, 7-9 March](https://flexdatabases.com/blog/crown-congress-philadelphia-7-9-march/) - Meet Flex Databases at the CROWN Congress, 7-9 March 2017, one of the most important networking and educational events in clinical trials industry. Natalia Blagodarova, QA Department Director, and Olga Sokolova, Associate Head PMO, will be happy to catch up and show you our platform. To plan a meeting drop us a line at bd@flexdatabases.com
- [SCOPE Summit, Miami, 24-26 January](https://flexdatabases.com/blog/scope-summit-miami-24-26-january/) - We are excited to announce our participation in the upcoming SCOPE Summit, 24-26 January 2017, Miami. To plan a meet with Evgenia Mikhalchuk, BD manager, drop us a line to evgenia.mikhalchuk@flexdatabases.com
- [PCT Europe. 16-17 November 2016, Vienna](https://flexdatabases.com/blog/pct-europe-16-17-november-2016-vienna/) - We are excited to announce our participation in the upcoming Partnerships in Clinical Trials Europe, 16-17 November 2016, Vienna. Meet with Evgenia Mikhalchuk, our BD Manager, she will be happy to catch up and show you around the system. To plan a meeting with Evgenia drop a line to her email evgenia.mikhalchuk@flexdatabases.com or give her a quick
- [PCT US. Boston, 05-07 October 2016. Meet us at booth #318](https://flexdatabases.com/blog/pct-us-boston-05-07-october-2016-meet-us-at-booth-318/) - We are excited to announce our participation in the upcoming Partnerships in Clinical Trials US, 05-07 October 2016, Boston, MA. Visit us at booth #318 to discuss e-Systems for clinical trials management and implementation possibilities. To plan a meeting, please drop us a line at bd@flexdatabases.com
- [Practical Risk-Based Monitoring implementation tips](https://flexdatabases.com/blog/practical-risk-based-monitoring-implementation-tips/) - Risk-based monitoring is a hot topic right now. It is burning through lots of US and European events. So, the world is changing, is your company ready to embrace it? We can remind ourselfs about the times of numerous papers, faxes, Excel tracking, manual tracking, blue ink signatures, etc. It wasn’t that long ago. Looking
- [DIA 28th Annual EuroMeeting. Hamburg, 6-8 April 2016. Meet us at booth #i7](https://flexdatabases.com/blog/dia-28th-annual-euromeeting-hamburg-6-8-april-2016-meet-us-at-booth-i7/) - We are excited to announce our participation in the upcoming DIA 28th Annual EuroMeeting, 6-8 April 2016, Hamburg, Germany. Be sure to plan and visit us at booth #i7. To plan a meeting, please drop a line to Evgenia Mikhalchuk our BD manager at evgenia.mikhalchuk@flexdatabases.com
- [5 Tips for Viewing Demos of Clinical Trial Management Systems](https://flexdatabases.com/blog/5-tips-for-viewing-demos-of-clinical-trial-management-systems/) - If you are looking for CTMS, here are some tips to get the max out of each live demo session. Live demos are very effective to determine whether this system will speed up your business processes and work for your company, how flexible the system and its provider can be. It helps evaluating the system just as
- [DIA 51th Annual Meeting, Washington, 14-18 June 2015](https://flexdatabases.com/blog/https-flexdatabases-com-blog-dia-51th-annual-meeting-washington-14-18-june-2015/) - Flex Databases will attend DIA 51th Annual Meeting in Washington. You are very welcome to our booth #1312. To arrange a meeting please contact us at contactus@flexdatabases.com
- [BIO Convention in San Diego, USA, 23-26 June 2014](https://flexdatabases.com/blog/bio-convention-in-san-diego-usa-23-26-june-2014/) - Flex Databases will attend BIO Convention in San Diego. Please contact us at contactus@flexdatabases.com to arrange a prescheduled meeting with Flex Databases! BIO International Convention is the largest venue for private company-to-company meetings in the world.
- [DIA 26th Annual EuroMeeting in Vienna, Austria, 25-27 March 2014](https://flexdatabases.com/blog/dia-26th-annual-euromeeting-in-vienna-austria-25-27-march-2014/) - Flex Databases attends DIA 26th Annual EuroMeeting in Vienna. At this meeting we are going to share our client experince together with R-Pharm. To arrange a meeting please contact us at contactus@flexdatabases.com
- [PCT in Vienna, Austria, 19-21 November 2013](https://flexdatabases.com/blog/pct-in-vienna-austria-19-21-november-2013/) - Flex Databases will attend Partnership in Clinical Trials 2013 in Vienna, Austria. To arrange a meeting please contact us at contactus@flexdatabases.com
- [DIA 49th Annual Meeting in Boston, USA, 23-27 June 2013](https://flexdatabases.com/blog/dia-49th-annual-meeting-in-boston-usa-23-27-june-2013/) - Flex Databases will attend DIA 49th Annual Meeting. Meet us at booth #2022! To arrange a meeting please contact us at contactus@flexdatabases.com
- [BIO-Europe in Barcelona, Spain, 11-13 March 2013](https://flexdatabases.com/blog/bio-europe-in-barcelona-spain-11-13-march-2013/) - Flex Databases will attend BIO-Europe 2013 in Barcelona, Spain. To arrange a meeting please contact us at contactus@flexdatabases.com
- [DIA 25th Annual EuroMeeting in Amsterdam, the Netherlands, 4-6 March 2013](https://flexdatabases.com/blog/dia-25th-annual-euromeeting-in-amsterdam-the-netherlands-4-6-march-2013/) - Flex Databases will attend DIA 25th Annual EuroMeeting in Amsterdam. To arrange a meeting please contact us at contactus@flexdatabases.com
- [DIA 48th Annual Meeting in Philadelphia, USA, 24-28 June 2012](https://flexdatabases.com/blog/dia-48th-annual-meeting-in-philadelphia-usa-24-28-june-2012/) - Flex Databases will attend DIA 48th Annual Meeting. Meet us at booth #3209. To arrange a meeting please contact us at contactus@flexdatabases.com
- [Flex Databases offers a discount for contracts signed in 2020](https://flexdatabases.com/blog/2020-discount/) - Request a demo via the button on top of the page or send us an e-mail to bd@flexdatabases.com to know more.
- [SCOPE Summit, February 18-21, 2020](https://flexdatabases.com/blog/scope2020/) - It seems that we created a new tradition – for 3rd year in a row, we start the year of events with SCOPE. Meet us in Orlando, Florida, on February 18-21. As usual, we’re participating as exhibitors so you can find us any day at booth #713! Evgenia Mikhalchuk, Global Director, Business Development & Marketing, Alexander
- [What are the main concerns of choosing CTMS and TMF during Brexit and how Flex Databases fixes them?](https://flexdatabases.com/blog/brexit-concerns/) - Many questions arise about Brexit, and whoever works in the clinical trials industry in the UK or with the UK are having many concerns now – nothing is clear about the final conditions. Here is a clarification of the most frequent concerns and how Flex Databases fixes them: Regulatory alignment In any Brexit case, we,

## Tag

- [Clients](https://flexdatabases.com/tag/clients/)
- [Clinical](https://flexdatabases.com/tag/clinical/)
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