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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 client 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 Operations 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

Astrum goes live with Flex Databases: phase one complete
November 4, 2026
Astrum goes live with Flex Databases: phase one complete

We’re proud to share a milestone with our partners at Astrum: the first phase of their Flex Databases implementation is now live.Project management and project time tracking now run in one shared system. Here’s what changes:– Operational teams log their time directly in Flex – no more local tools or Excel-based tracking– Project managers plan […]

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TMF Standard Model V1: A Major Change Is Coming to Clinical Research
October 22, 2026
TMF Standard Model V1: A Major Change Is Coming to Clinical Research

CDISC is introducing TMF Standard Model V1, the next evolution of the widely used TMF Reference Model. This is more than a new version – it represents a shift toward standardized, digitally managed clinical trial records. What’s changing? When will it happen? Community review of the draft is scheduled to begin this autumn, with the […]

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The Holy Triangle of TMF:  Is It Really Enough to Measure TMF Health by Tracking Its Completeness? 
October 13, 2026
The Holy Triangle of TMF:  Is It Really Enough to Measure TMF Health by Tracking Its Completeness? 

When vendors build tools to evaluate TMF health, they usually focus on three main KPIs: completeness,  timeliness and quality.  These metrics are obviously important, but are they enough?  A real TMF user will go further and ask the next question:  How long did it take the document to move through each of these stages?  The […]

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EDC Data Solution Specialist (Data Manager)
September 29, 2026
EDC Data Solution Specialist (Data Manager)

As an EDC Data Solution Specialist (Data Manager), you will work at the intersection of data, systems, and clinical research. You will translate clinical study requirements into practical EDC solutions – from understanding study protocols to building and testing electronic forms, configuring validation rules, and supporting clinical data throughout the study lifecycle. We are looking […]

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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.