eTMF in Clinical Trials
Complete 24/7 visibility into all your trial documentation, from anywhere in the world. File, review and sign every trial document in one validated eTMF – with AI-assisted filing, real-time completeness against the TMF Reference Model and inspector access when you need it.
500+
Companies using Flex Databases
3-10wks
to go live
90 days
minimum contract
21 CFR 11
validated
A Tuesday, before vs. after
Coordinator manually files Monday’s signed report into a TMF folderSigned report is filed automatically into the eTMF - no separate filing step
QA can’t tell if the TMF is complete until the audit gets scheduledCompleteness by milestone is visible on the dashboard, always
Giving an auditor access means exporting files or sharing a loginDedicated external access with its own audit log - no shared login
eTMF Compliance: Designed to Support Regulated Clinical Operations
Every module ships with these certifications built in — not a paid add-on for the studies that require them.
After an intensive selection and evaluation process comparing different service providers, ABX-CRO decided to select Flex Databases. The main deciding factors are the possibility of on-premise solutions for CTMS and eTMF as well as the flexibility of the different modules for managing clinical trials. Furthermore, Flex Databases meets ABX-CRO requirements regarding user-friendliness and interaction with internal software solutions very well.
Dr. Ulrike Schorr-Neufing
Director, Qualification & Training, ABX-CRO
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
Flex Databases helped us standardize and simplify critical TMF processes across departments. We significantly reduced manual work, improved audit readiness, and strengthened collaboration with sponsors. The centralized environment gave teams much better visibility and control over daily operations.
Dimitri Fitsialos
Integrated Therapeutic Solutions Inc.
Your Trial Master File Shouldn't Be a Mystery Until the Auditor Arrives
Flex Databases eTMF replaces the scattered folders, email attachments and manual filing that study teams currently use to prove a trial was run correctly — with one record, always current, always inspection-ready, always.
Key eTMF Software Benefits: Three Recurring Headaches, Removed
These map to what the platform actually does day to day — not abstract feature names.
Nobody knows if the TMF is complete until inspection day
Completeness & Oversight Dashboards
Get instant, secure access to your trial documentation from anywhere in the world. See missing documents, upload statistics and folder completeness by milestone, with automated to-do lists, flexible widgets and exportable reports.
Filing documents means re-typing metadata manually
Daily Filing Tools
Email a document directly into the eTMF, upload through a mobile app, drag and drop, or connect through WebDAV. Documents generated in CTMS file into the eTMF automatically, with zero manual effort, and AI proposes metadata for the rest.
Periodic review turns into a scavenger hunt
Simplicity Without Compromising Quality
Email a document directly into the eTMF, upload it into the system, drag and drop, or connect through WebDAV. Documents generated in CTMS are filed into the eTMF automatically, without a separate manual filing step.
Every Part of the eTMF, in Plain Terms
Six connected capability areas that work together by default.
Dashboard & visibility
Get instant, secure access to your trial documentation from any place in the world. See missing documents, upload statistics, and folder completeness by milestone or any other parameter — with automated to-do lists and exportable reports.
Real-time completeness by folder or milestone
Automated to-do lists
Missing document alerts
Flexible widgets and exportable reports
Document structure & organization
Simple TMF template creation and configuration, including the recommended TMF Reference Models. Custom metadata structures adapt to how your studies actually get organized, and OCR recognizes text in scans and photos, helping teams identify unreadable files before review.
TMF Reference Model-aligned templates
OCR text recognition in scans and photos
Custom metadata structures
Multilingual and special-character support
Daily filing & upload
Upload documents in seconds – email one directly into the eTMF, drag and drop, or connect through WebDAV. Documents generated in CTMS are filed automatically without a separate filing step, and review, approval, locking and signing happen with an embedded eSignature function.
Automated filing from CTMS
Email, drag-and-drop and WebDAV upload
Bulk email to sites, with a tracked communication record
Embedded eSignature workflow
Review & quality control
Imbedded quality review with both options: preliminary scheduled or ad-hoc assigned quality reviews can be managed right in the system with queries raised, assigned to the responsible team member, and closed within the review timelines.
QC processes as a part of the eTMF
In-built quality reviews assigned to the QA or SMEs as per folder of TMF
Queries, chats, comments – all the possible means of communication as a part of the system being tracked and audit trailed
Notification and reminders on what is to be done in every aspect – QC, reviews, expirations, and many more
Archiving, access & compliance
Inspection readiness becomes part of daily eTMF operations. Archiving includes an index and audit trail, alongside dedicated external access for inspectors, auditors and partners. Validation documentation and data privacy aligned controls are included.
One-click archiving with index and audit trail
Full audit trail and versioning, 21 CFR Part 11
Dedicated external access for auditors and partners
GDPR-compliant, fully validated
AI-powered filing
AI proposes metadata and filing locations as documents are uploaded, reducing manual work while keeping your team in control. It runs on separate, local servers within your own region — EU, US, or elsewhere — never in the public cloud, with thorough validation support included.
AI proposes metadata on upload
Continuous background processing
Runs on private, regional servers — not the public cloud
Validated AI-assisted filing workflow
AI That Files Your TMF — and Holds Up in an Inspection
Most of TMF work is classification, metadata and completeness checks — exactly the work AI does time faster. Ours is built for a regulated environment, not adapted to one.
Most filing happens by itself
Around 70% of documents can be classified and filed automatically out of the box, rising to roughly 80% after tuning to your TMF structure. Results vary by document mix, metadata quality and configuration. Your team reviews instead of retyping.
Validated for GxP use
The AI is covered by a GAMP 5 and FDA CSA-aligned validation framework — we validate the whole filing process, not just a model, and hand you the full validation package for your own audits.
Your data never leaves your control
AI runs on dedicated servers in your region — EU, US or elsewhere — never the public cloud. Encrypted connections, dedicated queues, and your data is never mixed with anyone else's.
People stay accountable, not algorithms
AI proposes, your team decides. Performance is monitored after go-live — drift detection, anomaly review and periodic re-verification — so quality doesn't quietly degrade over time.
Why Flex eTMF?
We’ve spent over a decade inside Trial Master Files — building TMF structures with CROs and sponsors since 2011, through hundreds of audits and inspections. That experience is now paired with something few vendors have: our own developed and validated AI-assisted filing workflow, running on servers in your region and supported by a GxP validation framework — not a chatbot bolted onto a folder tree. Today 100+ teams in 30+ countries keep their TMFs on Flex Databases, with support in the US, Europe and Asia.
Most eTMFs can only tell you what's filed — not what's missing or overdue
Three pillars, watched continuously
Completeness, timeliness and quality are monitored in real time across every study, country, site and milestone — inspection readiness is a daily state, not a fire drill before the audit.
Review and sign-off scattered across email threads and separate e-sign tools
Review and sign in place
Author, review, approve, lock and sign inside the eTMF with embedded e-signature — plus Office 365 co-authoring with comments and track changes, filed back as the final version.
Rigid upload flows force everyone through the same slow, narrow doorway
Capture documents any way you like
Email straight into the eTMF, drag and drop, upload from the browser, or connect the TMF as a drive on your desktop via WebDAV — whatever your team is used to already works.
Standalone eTMFs make you re-file every CTMS document by hand
Automatic filing from CTMS
Documents created in Flex CTMS are filed automatically into the correct eTMF folders — because both live on the same platform, not connected by a fragile integration.
Manual classification eats hours and still produces filing errors
AI files documents for you
AI proposes metadata and filing locations for review as documents are uploaded — running on dedicated servers in your region, never the public cloud, with validation support for the AI-assisted filing workflow.
Periodic QC review is usually a spreadsheet project of its own
Structured quality review, built in
Build checklists, run structured quality audits and resolve findings through in-built chat and comments on every file and folder — QC lives where the documents live.
Giving inspectors access means exports, shared logins or panic
Inspector access without compromise
Dedicated, controlled external access for inspectors, auditors and partners with its own logs — plus proper archiving with index and audit trail at study close.
Enterprise-grade usually comes with an enterprise-grade invoice
Enterprise capability, sensible cost
TMF Reference Model support, validation documentation and a complete audit trail — without enterprise-suite complexity or cost. You pay for the capabilities you use.
Weeks of vendor training before anyone can file a document
Intuitive from day one, with people behind it
A consistent web interface your team learns in days, not weeks — and our customer care team stays in touch throughout, not just during onboarding. Client feature requests genuinely reach our roadmap.
Time to implement
Shared drives & folders
Immediate, but nothing is controlled
FLEX eTMF
Typical go-live in 3–10 weeks
Legacy enterprise eTMF
6–18 months
Knowing what's missing
Shared drives & folders
Someone checks manually before audits
FLEX eTMF
Completeness, timeliness, quality tracked live
Legacy enterprise eTMF
Reports exist, often a separate module
Filing effort
Shared drives & folders
Everything manually
FLEX eTMF
AI-assisted classification + automatic filing from CTMS
Legacy enterprise eTMF
AI add-ons priced and sold separately
Inspector access
Shared drives & folders
Export packages or shared logins
FLEX eTMF
Dedicated external access with own audit log
Legacy enterprise eTMF
Present, but configuration-heavy
Changing the TMF structure
Shared drives & folders
Manual folder surgery
FLEX eTMF
Configurable by business users, DIA model built in
Legacy enterprise eTMF
Change request to the vendor
| Key Factors | Shared drives & folders | FLEX eTMF | Legacy enterprise eTMF |
|---|---|---|---|
| Time to implement | Immediate, but nothing is controlled | Typical go-live in 3–10 weeks | 6–18 months |
| Knowing what's missing | Someone checks manually before audits | Completeness, timeliness, quality tracked live | Reports exist, often a separate module |
| Filing effort | Everything manually | AI-assisted classification + automatic filing from CTMS | AI add-ons priced and sold separately |
| Inspector access | Export packages or shared logins | Dedicated external access with own audit log | Present, but configuration-heavy |
| Changing the TMF structure | Manual folder surgery | Configurable by business users, DIA model built in | Change request to the vendor |
One Platform That Grows With You
Add studies, countries and hundreds of users, and it's still the same login, the same TMF structure, the same platform — no migration project waiting at the other end of growth.
Your whole portfolio, not one study
Track TMF completeness and risk across every study, country and site your team runs — with cross-project reporting from a single dashboard.
Connects to what you already run
Flex supports integration with common CTMS, EDC, safety, Office 365 and email systems, so documents can flow into the eTMF without repeated entry or upload.
Access built around your org chart
Permissions by project role, country, site, folder and external user type — inspectors, sites and partners each see exactly what they should, nothing more.
Onboarding that scales with your team
A named implementation lead guides deployment and role-based onboarding for teams of 10 or 500, with a typical go-live in 3–10 weeks. The interface remains consistent across the Flex platform.
Fits Into Your Stack, Live in Weeks
Keep the systems your team already knows — Flex connects to them, so your documents land in the TMF without replacing anything.
Systems your team already depends on
Flex eTMF supports integration with the systems your team already runs, helping documents flow into the TMF without replacing established workflows.
- CTMS – documents are filed automatically
- WebDAV – work with the TMF as a desktop drive
- Office 365 – co-author, comment, track changes
- Single sign-on via LDAP and SAML
- Email – send documents straight into the TMF
- Every other Flex module, on the same data model
Accessible anywhere
Cloud by default, on-premise if your policy requires it — either way, your team just opens a browser and works. No client software to manage, no manual updates to schedule.
Hosting
Cloud or on-premise, your choice
Access
Any browser, any device — plus a mobile app
AI
AI data is processed in your region using dedicated queues and tenant-separated storage
Setup
Kickoff to go-live in 3–10 weeks
Support
Named implementation lead throughout
3–10
weeks from kickoff to go-live
Five eTMF Problems That Quietly Slow Down Every Trial
None of these show up as a single dramatic failure. They show up as a review that takes longer than it should, over and over, until an inspection makes it everyone's problem at once.
Nobody knows the TMF is incomplete until the inspector asks
Without a live view of missing documents and completeness by milestone, "are we inspection-ready?" is a question that gets answered by manually checking folders, not by looking at a dashboard.
COST
Gaps that surface during an inspection, not before it
Filing from CTMS, email and shared drives means re-typing metadata
A signed monitoring report has to be manually uploaded and tagged with the right metadata by hand, every time — a step that's both slow and the easiest place for a filing error to creep in.
COST
Hours of manual filing per week, per document owner
Periodic review turns into a scavenger hunt through folders
Without a pre-built list of what needs checking, a reviewer starts from the top of the folder tree every time — and queries about a specific document get resolved over email instead of next to the file itself.
COST
Reviews that take days instead of hours
Metadata gets assigned inconsistently, so search stops working
When metadata depends on whoever uploaded the document that day, search results and completeness reports become unreliable — so people stop trusting them and go back to browsing folders manually.
COST
Reports nobody fully trusts, so nobody fully uses them
Giving an auditor access means exporting everything or sharing a login
Without dedicated external access, an inspector, auditor or partner either gets an unwieldy document export or someone's own internal credentials — neither of which is a clean way to grant access.
COST
Access requests that take days to fulfill safely
Recognize more than two of these?
That's usually the point where a unified eTMF pays for itself before the next inspection.
How eTMF Software Fixes It: Inspection-Ready as a Daily State, Not a Project
Each problem above maps directly to something the platform does differently — not a feature list, a fix.
The Problem
TMF completeness invisible until an inspection
What changes with Flex eTMF
Live dashboard: missing documents, completeness by milestone, always current
The Problem
Filing from CTMS and email means re-typing metadata
What changes with Flex eTMF
Automated filing from CTMS, plus email and drag-and-drop upload
The Problem
Periodic review is a scavenger hunt
What changes with Flex eTMF
My Views: pre-built review lists, with inline chat to query a document
The Problem
Metadata assigned inconsistently by hand
What changes with Flex eTMF
AI proposes metadata automatically for review as documents are uploaded
The Problem
External access means exporting files or sharing logins
What changes with Flex eTMF
Dedicated, logged external access for auditors, inspectors and partners
| The Problem | What changes with Flex eTMF |
|---|---|
| TMF completeness invisible until an inspection | Live dashboard: missing documents, completeness by milestone, always current |
| Filing from CTMS and email means re-typing metadata | Automated filing from CTMS, plus email and drag-and-drop upload |
| Periodic review is a scavenger hunt | My Views: pre-built review lists, with inline chat to query a document |
| Metadata assigned inconsistently by hand | AI proposes metadata automatically for review as documents are uploaded |
| External access means exporting files or sharing logins | Dedicated, logged external access for auditors, inspectors and partners |
One eTMF Platform, a Different Problem Solved for Each Seat
Document & TMF coordinators
Re-checking metadata on every uploaded file by hand
AI proposes placement and metadata automatically as documents arrive
CRAs
Filing a signed report is a separate step after the visit
Signed reports file into the eTMF the moment they're closed.
QA & compliance
Proving the TMF is complete means a folder-by-folder check
Completeness by folder or milestone is visible on a live dashboard.
Sponsors overseeing a CRO
Waiting for a CRO to confirm the TMF is inspection-ready.
Direct visibility into completeness, without having to ask.
Auditors & inspectors
Getting access means a document export or a shared login
Dedicated external access with its own audit log — no shared login.
Site staff
Sending documents to the sponsor over random email threads
Bulk email straight from the eTMF, with a tracked record.
What Actually Changes in Week One With Flex eTMF
Not shared drives — what a switch from another eTMF platform actually looks like.
| Task | Typical eTMF platform | Flex Databases eTMF |
|---|---|---|
| Getting a new coordinator filing documents | Formal vendor training, weeks to proficiency | Intuitive enough to be productive within days |
| Uploading a batch of site documents | One-by-one through the web form | Email them in, drag & drop, or file from the desktop via WebDAV |
| Running a periodic QC review | Export a list, track findings in a spreadsheet | Checklists, findings and chat inside the TMF itself |
| Building a custom completeness report | Professional services quote required | Built by your own team, no quote needed |
| Getting a straight answer from support | Ticket queue, SLA measured in days | Direct line to an assigned Project Manager |
Task
Getting a new coordinator filing documents
Typical eTMF platform
Formal vendor training, weeks to proficiency
Flex Databases eTMF
Intuitive enough to be productive within days
Task
Uploading a batch of site documents
Typical eTMF platform
One-by-one through the web form
Flex Databases eTMF
Email them in, drag & drop, or file from the desktop via WebDAV
Task
Running a periodic QC review
Typical eTMF platform
Export a list, track findings in a spreadsheet
Flex Databases eTMF
Checklists, findings and chat inside the TMF itself
Task
Building a custom completeness report
Typical eTMF platform
Professional services quote required
Flex Databases eTMF
Built by your own team, no quote needed
Task
Getting a straight answer from support
Typical eTMF platform
Ticket queue, SLA measured in days
Flex Databases eTMF
Direct line to an assigned Project Manager
Why This eTMF Software Fits Every Type of Team
One configurable core, not a different product per company — each team gets what it actually needs from it.
CROs
Every sponsor user runs on the same platform, configured per study instead of re-platformed per client — so onboarding a new client is weeks, not months, keeping your team a real system expert.
Sponsors
Sponsors can own the instance, having oversight and audit history to track CRO changes, with live portfolio visibility across studies.
Academic & research institutions
Investigator-initiated and multi-site academic studies get the same validated audit trail and site oversight as commercial studies, without commercial-scale budgets or IT overhead.
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
Frequently asked about eTMF software
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.