All-in-One CTMS
One Clinical Trial Management System for the clinical development process. Data-based decisions. More insight – less effort. Plan, run and pay for your studies in one validated CTMS – from feasibility and site activation to monitoring visits and investigator payments. Integrated with eTMF, EDC and safety on one platform, so nothing is entered twice.
100+
Life Sciences teams
3-10 wks
to Go Live
90 days
minimum contract
21 CFR 11
validated
A Tuesday, before vs. after
CRA duplicates finalized visit notes into the TMF manuallyVisit reports filed into the eTMF the moment they’re signed
Finance emails a site to ask if the visit happened yetPayment triggers automatically on visit completion in EDC
PM builds an enrollment slide from three exportsEnrollment dashboard is already in real-time, always
CTMS Compliance: Designed to Support Regulated Clinical Operations
Core controls such as audit trails, electronic signatures, role-based access and reason-for-change tracking are included as standard.
"Flex Databases system is very flexible and user friendly — the team also has flexible ways of thinking."
Tameo Kobayashi
Chief Innovation Officer, CMIC Holdings
"Over 26 years at Agenus, this was the smoothest and fastest validated IT system we've implemented."
Craig Winter
CIO, Agenus Inc.
"Being able to build our own reports ourselves is a major advantage — and our feature requests reach the roadmap."
Ulrike Schorr-Neufing
Director, ABX-CRO
After an extensive evaluation, FGK chose the CTMS system from Flex Databases. The system convinced with its clear structure and intuitive handling. Both the flexible module for managing the payment of investigators and the possibility for CRAs to work offline with the system are clear advantages. Last but not least, the cooperation with the competent Flex Databases team during the evaluation phase also influenced the purchase decision.
Martin Krauss
Managing Director of FGK Clinical Research
Yes, we have worked with other softwares in the past, for different kind of activities, not only CTMS. What we can highlight of FDB software so far is that is adaptable to the needs of the users, is flexible in modifying to include our requirements. They are very customer focused.
Solti Team
Your Trial Data Shouldn’t Live in Five Places at Once
Flex Databases CTMS replaces the disconnected tools and manual processes that study, site and finance teams are currently juggling to track the same trial — with one record everyone works from.
Key CTMS Software Benefits: Three Recurring Headaches, Removed
Names of the system modules actually speak for what they do — not abstract feature names.
“I closed the visit Tuesday. I was still writing it up Thursday.”
Clinical Research Associate
Sound familiar?
Retyping the same visit into a second system
Chasing sign-offs by email for a whole week
No signal at the site, so notes wait for the hotel
CRA Activity Management
Confirmation and follow-up letters are generated in one click with trackers already filled in, e-signature workflows match your existing sign-off process, and reports, always in the actual version, can be filed even offline at low-connectivity sites.
“The sponsor asked for enrollment. I asked three spreadsheets.”
Study Manager
Sound familiar?
Rebuilding the same enrollment slide every cycle
Two versions of one number in the same meeting
Site payments reconciled by hand against milestones
Subject Tracking & Invoicing
Enrollment, inclusion curves and visit performed sit in one place instead of three spreadsheets, with exportable widgets and reports, and site payments triggered by the data confirmed in EDC – no manual reconciliation.
“Which contract version is Site 022 on? Nobody could say.”
Clinical Operations Lead
Sound familiar?
Site status spread across a shared drive
Every country's submission tracked its own way
Qualification records in one folder, contracts in another
Investigators & Sites Management
Every site’s status, contract, site staff, qualification and feasibility record lives in one site card, and submission packages across countries and studies are managed from a single, unified interface filed in eTMF automatically.
Every part of the CTMS in plain terms
Everything a project team needs to plan, run within the study, including payments — six connected capability areas that work together by default, so nothing has to be stitched together later.
Site visit management
Plan site initiation, IMV , interim and close-out visits from one calendar shared across the study team. Confirmation and follow-up letters generate automatically from templates pre-filled with site, contact and date details. Electronic-signature workflows can mirror your existing sign-off process.
Configurable visit types, workflows, report templates
Offline reporting with automatic sync
Study-specific checklists and required fields
Multi-step review and approval routing
Investigator & site oversight
Every site’s status, document, contract and qualification record lives on one card instead of scattered across a shared drive. Submission packages across countries and studies are tracked from the same interface, so the question “are we ready to activate Site 031?” arises it gets answered in seconds.
Feasibility and site selection tracking
Contract, license and certificate expiry alerts
Cross-country submission package management
Full communication history per site
Payments & budgets
Study and site budgets in multiple currencies, with payment rules that trigger from visit completion, procedures performed, or milestones reached — not from someone remembering to raise an invoice. Budget versions stay linked to the invoicing issued , so a mid-study amendment doesn’t break the payment history.
Configurable payment rules and overheads
Multi-currency, multi-version budgets
Online invoice approval and cancellation
Full status tracking per invoice
Enrollment & subject tracking
Inclusion curves, screen failures, and visit updates from the major data source – EDC –no export, no separate master sheet. Widgets and reports are exportable at any time, so a portfolio review doesn’t require a week of prep beforehand.
Real-time enrollment vs. plan
Visits performed and screen failure tracking
Exportable widgets, reports and graphs
Cross-study portfolio views
Reporting, analytics & risk-based monitoring
Most operational reports can be built in the system, since the reporting layer gets access to the same live data captured in CTMS and other parts of the system. Risk-based monitoring dashboards track key study KPIs and flag potential issues early. Teams can also build their own custom trackers, typically within days of go-live, without waiting for the vendor to develop them.
Imbedded report builder
Risk-based monitoring dashboards and KPIs
CRA performance and workload metrics
Automated alerts on any tracked parameter
Role-based dashboard access
Offline field reporting
Monitoring visits at rural or low-connectivity sites don’t stall the record. Reports are completed offline and sync automatically the moment connection is available, with the same audit trail and signature requirements as an online submission.
Full offline report completion
Automatic sync when reconnect
No data loss when offline and online edits overlap
Identical audit trail to online entries
Why Flex CTMS?
We’ve been building clinical trial software since 2011. Today, more than 500 teams from CROs, sponsors and research teams in over 40+ countries trust Flex with their studies. A dedicated support teams across the globe.
Most CTMS tools don’t go beyond monitoring — feasibility and payments live elsewhere
Truly end-to-end
Feasibility, start-up, site and investigator management, monitoring, subject tracking and site payments run in one CTMS — not stitched together from four separate tools.
Calendars, contracts and invoices in separate tools mean constant reconciliation
One operational backbone
Visits, subject data, contracts, invoices and KPIs share the same data model, so a change in one place doesn’t need re-entry everywhere else.
Changing a visit type or a log field usually means a developer ticket and a wait
Configurable, not custom-coded
Visit types, logs, workflows, budgets and reports are adjustable directly by the users —all the changes stay under your control, not a vendor’s queue.
Audit trails added after the fact rarely hold up well under scrutiny
Audit trail built for inspections
E-signatures, full audit trails and “reason for change” tracking are part of every core process from day one — not bolted on before an audit.
Dashboards that just display numbers don’t show you the risk
Actionable oversight
Portfolio-level KPIs let you drill down from portfolio level to study to country to site to CRA — so delays, risks and profitability issues can be problem-shot early, not at the review meeting.
A CTMS that doesn’t talk to eTMF, EDC or safety just relocates the silo
One platform, not a point solution
CTMS sits on the same platform as eTMF, EDC, PV, QMS, LMS and Project/Finance — one consistent backbone, not five separate vendor contracts.
Enterprise-grade usually comes with an enterprise-grade invoice
Enterprise capability, sensible cost
Enterprise-grade system capabilities without enterprise-suite complexity or cost. You pay for the modules you use.
Weeks of vendor training before anyone can file a visit report
Intuitive from day one, with people behind it
The interface is simple enough that new team members are working in days, not weeks — and our customer care team stays in touch throughout, not just during onboarding.
With big vendors, your feature request goes into a black hole
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. With Flex, you’re a partner, not ticket #48291.
Time to implement
Spreadsheets & point tools
Immediate, but nothing connects
Flex Databases CTMS
Typical go-live in 3–10 weeks
Legacy enterprise CTMS
6–18 months
Feasibility through payments
Spreadsheets & point tools
Spread across 3–4 separate tools
Flex Databases CTMS
One CTMS, start to finish
Legacy enterprise CTMS
Often sold as separate add-on modules
Changing a workflow or visit type
Spreadsheets & point tools
Manual, ad hoc
Flex Databases CTMS
Configured by business users, no code
Legacy enterprise CTMS
Change request to the vendor
Connects to eTMF, EDC, safety
Spreadsheets & point tools
Manual export and import
Flex Databases CTMS
Same platform, same data model
Legacy enterprise CTMS
Separate contract, separate integration project
Audit trail & e-signatures
Spreadsheets & point tools
Inconsistent or missing
Flex Databases CTMS
Built into every core process
Legacy enterprise CTMS
Present, but often added on per module
| Key Factors | Spreadsheets & point tools | Flex Databases CTMS | Legacy enterprise CTMS |
|---|---|---|---|
| Time to implement | Immediate, but nothing connects | Typical go-live in 3–10 weeks | 6–18 months |
| Feasibility through payments | Spread across 3–4 separate tools | One CTMS, start to finish | Often sold as separate add-on modules |
| Changing a workflow or visit type | Manual, ad hoc | Configured by business users, no code | Change request to the vendor |
| Connects to eTMF, EDC, safety | Manual export and import | Same platform, same data model | Separate contract, separate integration project |
| Audit trail & e-signatures | Inconsistent or missing | Built into every core process | Present, but often added on per module |
One Platform That Grows With You
Add studies, countries and hundreds of users, and it's still the same login, the same data model, the same platform — no migration project waiting at the other end of growth.
Your whole portfolio, not one study
Track enrollment, sites and spend across every study, country and currency your team runs — drilling from the full portfolio down to a single CRA.
Connects to what you already run
Flex can connect to common ERP, BI, EDC, eTMF and safety systems, so existing tools can remain part of your workflow.
Access built around your org chart
Clinical, finance, quality, operations and IT each see exactly what their role needs — by project, country, site or vendor.
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 — and the same platform keeps working as you add studies, countries or hundreds of new users.
Fits Into Your Stack, Live in Weeks
Keep the systems your team already knows — Flex Databases supports integrations that help trial data flow where it is needed.
Connect the systems you already depend on
Flex supports integration with the systems your team already runs.
- EDC and ePRO for data capture
- eTMF for trial documentation
- BI tools for broader reporting
- ERP for finance
- Safety and pharmacovigilance databases
- Every other Flex module, on the same data model
Accessible anywhere, live in 3–10 weeks
Cloud by default, on-premises if your policy requires— either way, your team just opens a browser and works. No client software to manage, no manual updates to schedule.
Hosting
Cloud or on-premises
Access
Access from any browser, any device
Support
Named implementation team
Setup
Kickoff to go-live in 3–10 weeks
3–10
weeks from kickoff to go-live
CTMS Problems That Quietly Slow Down Every Trial
None of these show up as a single dramatic failure. They show up as a week that takes longer than it should, over and over — and everything below has a direct fix, not just a workaround.
The same fact gets typed into four systems
A completed monitoring visit gets logged in the CTMS, then manually copied into the eTMF, referenced in a finance spreadsheet for payment, and mentioned again in a status email to the sponsor. Each copy can drift from the others.
COST
2–4 hours of re-entry per CRA, per week
Site visit tracking lives in someone’s inbox
Without a shared calendar, “have we visited Site 022 yet?” gets answered by searching email threads and a personal spreadsheet, not by looking at a system of record everyone trusts equally.
COST
visibility gaps that surface during, not before, an audit
Investigator payments lag behind actual work
When visit completion and payment triggers are in separate systems, someone has to manually match one to the other before an invoice can be issued — and it’s usually the least automated part of anyone’s week.
COST
payment delays that damage site relationships – hence your recruitment
Enrollment reporting means building a slide deck repeatedly
A portfolio-level enrollment view usually means exporting from each site or study system, pasting into a master sheet, and re-checking the formulas — every single reporting cycle.
COST
a stale number is often worse than no number
Audit prep becomes a reconciliation project
When the operational record and the regulatory record live apart, proving they agree — visit by visit, signature by signature — becomes a manual project that starts weeks before the inspector arrives, instead of being true by default.
COST
Weeks of QA time spent reconciling, not improving
Recognize more than two of these?
That’s usually the point where a unified CTMS can begin to pay for itself.
How CTMS Software Fixes It: One Record Instead of Five Copies of the Truth
Each problem above maps directly to something the platform does differently — not a feature list, a fix.
The Problem
Visit data re-typed into 3–4 systems
What changes with Flex CTMS
One record shared automatically with eTMF, finance and reporting
The Problem
Visit tracking lives in email and personal spreadsheets
What changes with Flex CTMS
Shared visit calendar with role-based visibility for every study
The Problem
Payments lag behind completed visits
What changes with Flex CTMS
Payment triggers fire automatically on visit or milestone completion
The Problem
Enrollment slides rebuilt from exports each cycle
What changes with Flex CTMS
Live enrollment dashboard, exportable, always current
The Problem
Audit prep is a manual reconciliation project
What changes with Flex CTMS
One continuous, timestamped audit trail across every module
| The Problem | What changes with Flex CTMS |
|---|---|
| Visit data re-typed into 3–4 systems | One record shared automatically with eTMF, finance and reporting |
| Visit tracking lives in email and personal spreadsheets | Shared visit calendar with role-based visibility for every study |
| Payments lag behind completed visits | Payment triggers fire automatically on visit or milestone completion |
| Enrollment slides rebuilt from exports each cycle | Live enrollment dashboard, exportable, always current |
| Audit prep is a manual reconciliation project | One continuous, timestamped audit trail across every module |
One CTMS Platform, a Different Problem Solved for Each Role
CRAs
Manually writing the same visit summary twice
Templates auto-fill from study data; the report becomes the record and transfers to eTMF automatically.
Clinical operations & PMs
Chasing sites for a status update before a sponsor call
A live dashboard answers the question before it’s asked.
Finance & contracts
Reconciling completed visits against unpaid invoices
Payment triggered by the same record the CRA closed.
QA & compliance
Rebuilding the audit trail from separate systems before an inspection
One continuous, timestamped trail across every module, always.
Sponsors overseeing a CRO
Waiting on a monthly status deck to know where a study stands
Live portfolio-level visibility across sites, without waiting for a monthly deck.
Site staff
Learning a different portal for every sponsor they work with
A consistent site experience across studies managed on the platform.
What Changes First With Flex CTMS
No spreadsheets — what a switch from another CTMS platform actually looks like.
| Task | Typical CTMS platform | Flex Databases CTMS |
|---|---|---|
| Getting a new CRA productive | Formal vendor training, weeks to full proficiency | Getting a straight answer from support |
| Reviewing site payments across the portfolio | Pull a separate export per study | One dashboard across every study |
| Escalating a protocol deviation | Logged in a separate QMS tool, re-entered by hand | Logged once, visible in CTMS and QMS immediately |
| Trying a new report layout | 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 a named implementation lead |
Task
Getting a new CRA productive
Typical CTMS platform
Formal vendor training, weeks to full proficiency
Flex Databases CTMS
Getting a straight answer from support
Task
Reviewing site payments across the portfolio
Typical CTMS platform
Pull a separate export per study
Flex Databases CTMS
One dashboard across every study
Task
Escalating a protocol deviation
Typical CTMS platform
Logged in a separate QMS tool, re-entered by hand
Flex Databases CTMS
Logged once, visible in CTMS and QMS immediately
Task
Trying a new report layout
Typical CTMS platform
Professional services quote required
Flex Databases CTMS
Built by your own team, no quote needed
Task
Getting a straight answer from support
Typical CTMS platform
Ticket queue, SLA measured in days
Flex Databases CTMS
Direct line to a named implementation lead
Why This Clinical Trial Management System Fits Every Type of Team
One configurable core, not a different product per segment — 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 CTMS 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.