Software for LifeScience to manage all in one – trials, documents, quality & people

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.

Gain complete visibility into all of your trial documentation

  • Get instant safe access to your trial documentation from any place in the world.
  • Ensure constant audit readiness of your TMF.
  • Upload documents in seconds, see missing files, review, and correct everything in real time.

Make the complex financial part of your project easy

  • Plan and allocate resources and workload for an unlimited number of projects.
  • Track and analyze project performance with automated reporting.
  • Manage all project-related expenses in one place.

Ensure robust and compliant pharmacovigilance activities throughout all the trial stages

  • Manage all PV processes within one system.
  • Communicate with partners and regulatory authorities directly via EDI gateways.
  • Make reports in any format, required by regulatory authorities.

Manage all quality-related activities and personnel qualification level

  • Manage SOPs, audits, incidents, CAPA, and all the quality-related activities.
  • Organize easy onboarding of new employees with automatically assigned training.
  • Get a complete view of your employees’ knowledge level with advanced reporting.

Blog

AI in TMF
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 […]

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Speaker announcement at QA Virtual Conference by RQA

On May 21, 12:00 CET, 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 […]

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OCT_Barcelona_2024
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 […]

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eTMF FAQ
eTMF FAQ – 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, […]

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What they say about us

John Douglas Snowden
Senior Vice President of Technology Innovation at NCGS, Inc.
NCGS has partnered with Flex to utilize nearly the entire suite of cloud-based modules Flex has to offer for the industry. NCGS believes in Flex’s vision for their platform as it so closely ties to our own ideals of uniformity and simplicity in operations and the delivery of true quality.
Tameo Kobayashi
Chief Innovation Officer, Director, Business Innovation Dept., CMIC HOLDINGS Co., Ltd.
Flex Databases system is very flexible and user friendly. In addition, most importantly the team have much much flexible ways of thinking! I am very proud that we did choose Flex Databases as our platform in CMIC APAC offices.
Joshua Baisley, H.B.Sc.
VP, Clinical Design and Delivery
As we have begun the installation process for Flex Databases system for use with the Clinical Trial Management group, the team at Flex Databases have made this process efficient and organized along with answering any questions that come up internally and jumping on additional meetings with our team to ensure that everything is understood throughout the set up and training process.

Clients

Stallergenes Greer logo
Stallergenes Greer Chooses Flex Databases eTMF to Enhance Inspection Readiness and Oversight Efforts

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 […]

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how we implenented eTMF
How we implemented eTMF & developed SOPs in 3 weeks for iRenix

And here’s the twist – while iRenix was laser-focused on their operations and study start-up processes, we rolled up our sleeves to deliver a full-on, turn-key eTMF setup from scratch.

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Deloitte and Flex Databases
Deloitte and Flex Databases forge strategic alliance to drive digitalisation in Life Sciences across Europe

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 systems.

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WSG selected Flex Databases eTMF
WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management

WSG selected Flex Databases eTMF & CTMS to centralize and optimize study management.

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What sets Flex Databases apart

Easy implementation

We can deliver a fully functional system in the timeframe from 3 to 10 weeks, depending on the сlient involvement and requirements.

Complete data safety

We have a robust backup & disaster recovery and customer data protection strategy, including distributed data storages around the world.

Full compliance

Flex Databases is compliant with all major international and local regulations such as: ICH GCP E6 R2, FDA 21 CFR Part 11, GDPR, etc.

Flexible solution

Easily configure every part of our proprietary platform. The system is fully managed by end users. No installation required.

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.