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Software for Life Sciences
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

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.

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.

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.

Ajay Sadhwani

SVP Operations, Harbor Clinical

Technology plays a critical role in how we manage safety data. A validated, flexible system allows us to stay inspection-ready while supporting both small and growing pharmacovigilance portfolios.

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.

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.

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

How ITS Cut Manual Safety Tracking by 60% and Strengthened PV Oversight Across Clinical Trials
July 15, 2026
How ITS Cut Manual Safety Tracking by 60% and Strengthened PV Oversight Across Clinical Trials

About Integrated Therapeutic Solutions Integrated Therapeutic Solutions (ITS) is a clinical research organization conducting multi-country clinical trials and supporting post-marketing needs across a growing sponsor portfolio. As case volumes increased, so did the complexity of managing pharmacovigilance activities from safety event intake and workflow tracking to regulatory reporting and cross-functional coordination with clinical operations teams. […]

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Is Your EDC Really Modern If Someone Still Has to Re-Enter Every Serious Adverse Event?
July 7, 2026
Is Your EDC Really Modern If Someone Still Has to Re-Enter Every Serious Adverse Event?

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 […]

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Validating AI in GxP Environments: The Flex Databases Approach to eTMF Compliance
June 30, 2026
Validating AI in GxP Environments: The Flex Databases Approach to eTMF Compliance

The pharmaceutical industry faces a familiar paradox: the tools that promise to make regulatory compliance faster and smarter also introduce the most complex new compliance questions. Nowhere is this more visible than in AI-powered Trial Master File (TMF) management. At Flex Databases, we have developed a validation framework rooted in GxP principles, risk-based thinking, and […]

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The Quiet Revolution in TMF: How AI Document Classification Turns Routine into a Background Task
June 25, 2026
The Quiet Revolution in TMF: How AI Document Classification Turns Routine into a Background Task

AI in Trial Master File management has quietly stopped being a someday idea. It’s not a pilot and it’s not a roadmap promise – it’s something clinical teams reach for on an ordinary Tuesday. The interesting part isn’t that AI can file a document; it’s how calmly and predictably it does it now – with […]

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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.