One Platform for Clinical Trials. Where Everything Actually Connects.
Validated and interconnected eClinical system with all the necessary parts under the same control and access: CTMS, eTMF, EDC, Pharmacovigilance, LMS, QMS and Project Management. A signed visit report in CTMS files itself to eTMF. An SAE entered once in EDC reaches the safety report submitted from the Pharmacovigilance system. Built by people who know clinical trials from the inside.
100+
Clients
30+
Countries
3-10 wks
to Go Live
Since 2011
Building clinical trials software
Life on Flex, before vs. after
Five separate systems, five vendors, five contracts to manageOne platform, one vendor, one contract
The same data re-typed between tools, drifting apartEntered once, used everywhere it's needed
An IT integration project per system pairConnected by default, from day one
Hours spent filing documents and coding terms by handValidated AI does the repetitive part — your team reviews
Compliance: Designed to Support Regulated Clinical Operations
Core controls such as audit trails, electronic signatures, role-based access, backup and disaster recovery are included as standard. The platform is designed to support 21 CFR Part 11, HIPAA, GDPR and ICH GCP requirements, with a validation approach aligned with GAMP 5.
All-in-One Platform, One Data Model
Use one module or the whole platform — everything you add later lands on the same data model, and new products join the platform regularly.
CTMS
Monitoring activities, subjects’ statuses, sites and invoicing in real time – visit scheduling, payment rules and site budgets in one place.
eTMF
Completeness visibility through trial documentation, expected documents, and quality review results – continuous insight into inspection readiness, AI-assisted filing, review and e-signature in place.
EDC
Zero-code eCRF build, integrated RTSM and ePRO, risk-based monitoring, AI-assisted coding and CDISC exports – with go-live starting from 3 weeks.
Pharmacovigilance
Case processing, E2B(R3) gateway submissions and built-in signal detection — drugs, devices and vaccines in one validated system.
LMS & QMS
SOPs, audits, vendor management, incidents and CAPA connected to training – one closed loop from finding to completed, e-signed training.
PM & Budgeting
Turn approved budgets into project plans and invoicing rules – with earned value, FTE utilization, timesheets and expenses considered.
AI in Clinical Trials
AI-assisted workflows across the platform – TMF filing, medical coding and signal detection – let AI handle repetitive work while your team keeps oversight.
"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."
Craig Winter
CIO, Agenus Inc.
"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."
Ajay Sadhwani
SVP Operations, Harbor Clinical
"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."
Martin Krauss
Director of FGK Clinical Research
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.
Ulrike Schorr-Neufing
Director Personnel & Qualification
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.
Tameo Kobayashi
Chief Innovation Officer, Director, Business Innovation Dept., CMIC HOLDINGS Co., Ltd.
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.
Simon Rückinger
Managing Director at Metronomia Clinical Research GmbH
Entered Once. Spread across the whole system.
The most cost-consuming thing in clinical operations is manual data input of the same data performed multiple times. At Flex Databases all the modules share one single source of truth transferring it across all the parts of the system automatically.
EDC → Pharmacovigilance
A serious adverse event entered at the site reaches the safety team without anyone re-typing it – no export, no email, no version drift.
How Flex PV worksCTMS → eTMF
A visit report signed in CTMS files itself into the correct TMF folder automatically – the moment it’s signed, not when someone is looking for it.
How Flex eTMF worksQMS → LMS
An updated SOP is automatically reassigned as a training to the dedicated team, completed with a 21 CFR Part 11 compliant e-signature and a training certificate – no manual training creation, email blasts, no printed forms.
How LMS & QMS worksTimesheets → PM & Budgeting
Actual hours captured in project performance, earned value and invoicing automatically – percent-complete calculated from real data, not typed into a tracker.
PM & BudgetingBuilt for Your Perspective of the Study
One configurable platform suits for different models across clinical research.
CROs
Run every sponsor account on one platform, configured per study — margins visible per client, onboarding in weeks, not months.
Sponsors
Sponsors can own the instance, preserving oversight and audit history across while providing CROs with specific access to assigned studies or even only folders in TMF.
Academic & research institutions
Validated audit trail and site oversight for investigator-initiated trials – even without commercial budgets or an IT department in place.
Why Flex Databases?
Our products are built by people with experience in clinical operations, data management and pharmacovigilance. Since 2011, more than 100 CROs, sponsors and research teams in over 30 countries have run their studies on Flex Databases, supported by teams located in multiple time zones.
Live in 3–10 weeks
A fully functional, validated system delivered in weeks, with a named implementation lead guiding the process from kickoff through training and go-live.
Enterprise capability, sensible cost
The features of the big enterprise systems offered at a price that doesn’t require board approval – users × modules, unlimited projects and sites.
Intuitive from day one, with people behind it
Teams are productive in days, not weeks – and our customer care stays in touch from the kickoff and through day-to-day operations.
Configured by you, not coded by us
Reports, workflows, trackers and views are under end-user control — changes happen in your team, not in a vendor's development queue.
Cloud or on-premise, your choice
Web-based access from any browser and device – hosted in the cloud, on a dedicated server or even on your own servers if your data governance requires it.
Your feedback shapes the product
Client feature requests genuinely reach our roadmap — teams like ABX-CRO name it as one of the reasons they stay.
AI That Holds Up in an Inspection — Not AI for AI's Sake
AI-assisted workflows take on repetitive work in document filing, medical coding and signal detection, so your team can focus on reviews and decisions.
AI TMF filing
Around 65% of documents can be classified and filed automatically out of the box, rising to roughly 80% once tuned to your TMF structure. Results vary by document mix, metadata quality and configuration. Your team reviews instead of filing.
AI medical coding
WHODrug and MedDRA terms are proposed automatically in EDC for coder review, helping accelerate coding and improve consistency using dictionaries your team already trusts.
ML signal detection
MGPS and EBGM scores, machine learning and neural network methods surface product–event combinations in dashboards for earlier review.
AI proposes — your team decides
Every AI-assisted outcome can be reviewed and overridden by an authorized user. AI workflows are supported by a GAMP 5- and FDA CSA-aligned validation framework with ongoing monitoring after go-live, while AI data is processed on dedicated servers in your region and kept separately from other customers’ data.
Trusted Across Clinical Research Since 2011
15+
Years of operations
500+
Companies using Flex Databases
45,000+
Users across the globe
100+
Clients
20,000+
Daily active users
10m+
Documents
2,000+
Clinical trials
30+
Countries
Clear Pricing, Fast Implementation
Two things teams usually can't get a straight answer to – here they are upfront.
Pricing without the games
Core subscription pricing is based on users × modules. Projects and sites are unlimited, the minimum contract is 90 days, and ROI calculators help estimate value before you speak with sales.
Typical go-live in 3–10 weeks
A fully functional, validated system from contract sign-off to production environment – kick-off, analysis, QA environment, UAT and training, with a named team on our side throughout the implementation and beyond.
From the Blog
Talk to us. See it yourself
Skip the generic demo. A specialist who works with this platform every day will walk you through it live, answer the hard questions directly, and show you exactly how it would run in your organization — not a script, not a slide deck.