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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.
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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.
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Smarter Trials. Faster Outcomes. All-in-one Electronic Data Capture with built-in RTSM, ePRO, and full compliance.

  • Build and deploy studies in record time
  • A clean, intuitive interface for sites and investigators
  • Randomization and trial supply management – fully integrated
  • Real-time patient-reported outcomes
  • Built for Every Stakeholder
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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.
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Ensure robust and compliant pharmacovigilance activities throughout all the trial stages

  • Manage all PV processes within one system.
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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.
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compliant with FDA
ISO 9001-2015 label certification new version
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ISO 27001_2022

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.

100+

Clients

20 000+

Daily users

10M+

Documents

2 000+

Clinical trials

30+

Countries

Trusted by the market leaders since 2011

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What They Say About Us

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.

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.

Craig Winter

CIO, Agenus Inc.

I have been with Agenus for over 26 years. Over those 26 years, our Flex CTMS and TMF implementation is the smoothest and fastest implementation of a validated IT system we have done.

Cheryl Marron

Manager Clinical Operations

We were searching for a flexible yet straightforward eTMF solution for one of our biotech clients. We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time.

Ulrike Schorr-Neufing

Director Personnel & Qualification

We have been using Flex Databases software for about 2.5 years now. One major advantage of Flex Databases CTMS is the ability to create specific reports ourselves. Additionally, we value that our feature requests are taken seriously by Flex Databases and added to their development roadmap. We also benefit from their customer-specific configuration service.

Martin Krauss

Director of FGK Clinical Research

FGK selected Flex Databases for CTMS and TMF due to clear structure, intuitive interface, flexible investigator payment module, offline access for CRAs, and positive cooperation with the Flex Databases’ team.

Simon Rückinger

Managing Director at Metronomia Clinical Research GmbH

We were searching for a flexible yet straightforward eTMF solution for one of our biotech clients. We have been working with Flex Databases for our internal project management and budgeting and their eTMF solution also convinced us. The Flex Databases team was incredibly helpful with setting the system up in no time.

Lídice Vidal

Chief Clinical Օperations Officer

We have made a journey of almost two years now, since we were exploring new vendors to change our CTMS system in May 2022, until the deployment of the system last March 2024. It would not be possible without the kind and patient support of Flex team! All the team we have encountered during this time have listened attentively to our needs and doubts, have perfectly understood them, and have always provided us with new options and possible solutions.

Blog

What CROs Should Look for in CTMS and eTMF During a Tender
September 2, 2025
What CROs Should Look for in CTMS and eTMF During a Tender

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 […]

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Integrations in Clinical Trials: An IT/ETL Perspective
August 28, 2025
Integrations in Clinical Trials: An IT/ETL Perspective

How Flex Databases connects your study ecosystem – reliably, securely, and at scale.  Why integrations matter to sponsors and CROs  Integration means that data entered once in a system of record is propagated automatically wherever it is needed. For clinical operations teams this translates into:  Core integration patterns we see most often  1) EDC → […]

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Key Changes to EU Pharmacovigilance Regulation: What You Need to Know
August 14, 2025
Key Changes to EU Pharmacovigilance Regulation: What You Need to Know

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 […]

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How Much ROI Can You Expect from eTMF and CTMS? 
July 31, 2025
How Much ROI Can You Expect from eTMF and CTMS? 

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, […]

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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.