Enterprise-Grade Compliance, Sized for a Grant Budget
One eClinical platform for investigator-initiated and multi-site academic trials — CTMS, eTMF, EDC and more. Turn on only what one study needs. No IT department required, no enterprise contract to justify to your grants office.
2–4 wks
to go live
90 days
minimum contract
100+
organizations, every size
21 CFR 11
validated
A coordinator's Tuesday, before vs. after
Chasing a protocol deviation logged somewhere in an inboxEvery deviation logged and dated automatically, ready for the IRB
Rebuilding the funder's progress report from five spreadsheetsExporting a current enrollment report in one click
Re-explaining the shared drive to a new research assistantNew team member logs into the same system every study uses
Validated to the Standard Your IRB Already Recognizes
The same compliance foundation commercial trials use — so an ethics committee or auditor isn't reviewing an unfamiliar system.
Electronic signatures and timestamped audit trails built into the base system, not a paid add-on for the studies that require them.
Quality management and information security certification behind every module — the same bar commercial sponsors are held to.
A track record across client and regulatory audits, so "who validated this?" has an answer before an inspector asks it.
Validated Security, Without an IT Department of Your Own
The part that matters most when there's no dedicated IT or validation staff on your research team.
Hosting, your choice
Cloud hosting in the EU or US, or on your institution's own servers if policy requires it.
Role-based access for rotating staff
Give each student, resident or coordinator exactly the access their role needs — and remove it just as easily when they move on.
Backups & continuity
Automatic daily backups and a recovery plan, so a technical failure never threatens a record your IRB relies on.
Nothing to validate yourselves
The system arrives pre-validated, so your research unit never has to build or prove compliance from scratch.
What makes trial management hard without a pharma budget behind it
Academic and investigator-initiated trials carry the same compliance expectations as commercial ones — usually with a fraction of the budget, staff and time.
Enterprise systems are priced for pharma, not for a grant
A commercial CTMS quote assumes a multi-million-dollar trial portfolio. A single investigator-initiated study funded by a two or three-year grant can't justify that contract — so most academic teams default to spreadsheets instead.
COST
A budget mismatch that pushes teams back to manual tracking
There's no IT department to validate a new system
Standing up and validating software normally takes a dedicated IT and quality team — support most academic research units simply don't have on staff.
COST
Months of unbudgeted validation work falls on the coordinator
Staff turn over every year or two
Research coordinators, students and residents rotate through constantly. Every departure means re-explaining whatever ad hoc mix of spreadsheets, email and shared drives the last person set up.
COST
Institutional knowledge walks out the door with every graduation
One coordinator runs five studies at once
Without one shared system, a coordinator juggling multiple protocols ends up with a different tracking method for each one — and no single place to see everything at a glance.
COST
Hours lost switching between inconsistent, ad hoc systems
IRB and funder reporting means compiling everything by hand
Progress reports, safety reports and protocol deviation logs for the IRB and the funding body get assembled from whatever records exist — usually right before a deadline.
COST
Reporting becomes a fire drill instead of a byproduct of daily work
Running an investigator-initiated trial right now?
We can show what a validated system looks like, scoped to a single study's budget.
A validated system, scoped to what one study actually needs
The Problem
Enterprise systems priced for a pharma portfolio
What changes with Flex
Modular pricing scoped to a single study or grant
The Problem
No IT department to validate a new system
What changes with Flex
Pre-validated out of the box — nothing for your team to build
The Problem
Staff turn over constantly
What changes with Flex
A system every new coordinator learns in a day, not a month
The Problem
IRB and funder reporting compiled by hand
What changes with Flex
Reports and audit trail ready to export whenever they're needed
| The Problem | What changes with Flex |
|---|---|
| Enterprise systems priced for a pharma portfolio | Modular pricing scoped to a single study or grant |
| No IT department to validate a new system | Pre-validated out of the box — nothing for your team to build |
| Staff turn over constantly | A system every new coordinator learns in a day, not a month |
| IRB and funder reporting compiled by hand | Reports and audit trail ready to export whenever they're needed |
One Modular Clinical Trial Management Platform, Sized to One Study or Many
Not an enterprise suite priced for a pharma portfolio, and not a spreadsheet held together with hope. Turn on only the modules an investigator-initiated trial needs — start with CTMS or eTMF alone, and add more only if a multi-site or multi-grant program grows into needing them.
Why unified beats spreadsheets
One place your whole research unit already trusts
Site visits, documents, deviations and IRB correspondence live in one record, not scattered across whoever's laptop happens to have the latest version.
CTMS
Track site visits and monitoring for one study or a whole cooperative group, from one calendar.
eTMF
An inspection-ready file an IRB or auditor can review without a translation project.
EDC
Build case report forms for an investigator-initiated protocol without hiring a developer.
Pharmacovigilance
Handle safety reporting requirements without standing up a separate system for one study.
QMS
Track protocol deviations the way an IRB expects to see them — consistently, not from memory.
LMS
Onboard rotating students, residents and coordinators with training that's already built.
Project & Budget
See what's left of the grant budget without rebuilding a spreadsheet every quarter.
DMS
Store IRB correspondence and grant documents separately from any single study's TMF.
Only need one thing for now?
Start with CTMS or eTMF alone for a single study — every other module is already there if your program grows.
Talk to a specialist →Beyond our own modules
Connects to what your institution already uses
Your university's grant management or IRB system doesn't need to be replaced. Our platform connects easily to what you already have, so nothing has to change overnight.
What each module means for an academic research team specifically
The same eight modules, read through what actually changes for a lean team running investigator-initiated trials.
Visit schedules, monitoring and site status live in one calendar — whether it's a single-site investigator-initiated trial or a multi-site cooperative group study.
- One calendar for a single study or many
- Configurable to a protocol's own visit schedule
- Simple enough for a part-time coordinator
- No separate system needed per protocol
Documents are organized to a standard structure from day one, so an IRB reviewer or auditor finds what they’re looking for without a coordinator walking them through an ad hoc filing system.
- Standard TMF structure, ready for review
- Reduces manual reconciliation before review
- Consistent across every study a unit runs
- Keeps the study record consistent through staff turnover
Case report forms for an investigator-initiated protocol can be built directly by the study team using visual configuration tools, without a separate custom-development project.
- Protocol-specific forms without custom development
- Built and edited by the study team directly
- Consistent data structure across studies
- No developer contract required
When a protocol requires formal safety case handling, it’s a module turned on inside the same account — not a separate specialist system to license and learn for one study.
- Safety case intake inside the same platform
- Signal detection reporting, aligned to global rules
- Turned on only if a protocol requires it
- Shared audit trail with CTMS and eTMF
Protocol deviations get logged and dated as they happen, rather than reconstructed from memory when the annual IRB report comes due.
- Deviation logging built into the daily workflow
- Consistent record, ready for IRB review
- Same audit trail standard as trial data itself
- No separate tracker to maintain by hand
New coordinators, students and residents complete role-specific training inside the same login they’ll use for the study – no separate onboarding packet to maintain each rotation.
- Training assigned per role, not per person from scratch
- Completion tracked and certified automatically
- Fast enough for a one-semester rotation
- Consistent across every study a unit runs
Grant budgets are tracked against actual study milestones, so “how much runway is left” has a direct answer instead of a manually updated spreadsheet nobody’s fully sure is current.
- Budget tracked against real study activity
- Live view of remaining grant funds
- Simple enough for a single-study budget
- Ready for funder financial reporting
How Pricing Actually Works
Not a number — a logic. Exact figures depend on your study and modules.
Priced by module, not by promise
Pay only for the modules a single study needs — CTMS or eTMF alone, or more, priced accordingly.
Scoped to a study or a grant
A single investigator-initiated trial is priced like a single investigator-initiated trial, not an enterprise contract.
No penalty for a small team
A two-person research unit isn't priced like a two-hundred-person CRO.
Exact numbers depend on your protocol and modules — ask on the call, no enterprise minimum required.
Get exact numbers on a callWhat Onboarding Actually Looks Like
Scoped to a single protocol, broken into what actually happens each stage.
1
Week 1
Kickoff & protocol setup
A named implementation lead sets up your protocol's specific visit schedule and required fields.
2
Week 2-3
Team training
Coordinators, PIs and rotating staff get trained on exactly the parts of the system their role touches.
3
Week 4
Go-live
The study goes live, ready for its first enrolled subject — and ready to show an IRB exactly how it's tracked.
Why Flex Databases, Specifically, for an Academic Team
Investigator-initiated trials carry the same regulatory weight as commercial ones — but rarely the same budget or IT team. Here's what's different about running academic research on Flex: commercial-grade validation and oversight, scoped and priced for the way academic work actually runs. We've built clinical trial software, and only clinical trial software, since 2011.
A spreadsheet is free, but it's not validated — and an inspector knows it
Commercial-grade validation, out of the box
Audit trails, e-signatures and a validation package come built in and 21 CFR Part 11-ready — your investigator-initiated trial gets the same inspection-ready foundation as a commercial program, with nothing to build by hand.
Enterprise CTMS is priced for a pharma portfolio you don't have
Scoped and priced for one study
Subscription is users × modules with unlimited projects and sites and a 90-day minimum — so a single grant-funded study pays for exactly what it uses, not for a portfolio-sized license.
There's no IT or validation department to stand up a system
No IT team required
Cloud-based and validated on delivery, configured by a named implementation lead — your researchers and coordinators run the study in a browser, without a dedicated IT or validation function behind them.
Rotating students, residents and coordinators churn through the study
Onboarding and training built in
LMS & QMS assigns the right training to each new starter automatically, e-signed and recorded — so constant turnover of students and coordinators stops being a compliance risk.
Each capability is a separate tool the grant has to fund and connect
CTMS, eTMF, EDC, PV & more on one data model
Data capture, documentation, safety and oversight on one platform — a signed visit report becomes the eTMF record, an SAE reaches safety, with no integrations for a small team to maintain.
Enterprise rollouts take 6–12 months the grant timeline doesn't allow
Enrolling in weeks, not semesters
From kickoff to first enrolled subject in 2–4 weeks — your study starts within the grant period, not after a rollout longer than some trials.
Multi-site academic networks lose the thread between sites
Multi-site oversight in one place
Run a whole academic network on one instance — status, documents and safety across every site in a single view, with role-based access so each site sees only its own.
Homegrown trackers hold the only copy of the study record
Your data, portable and yours
Standards-ready exports (CDISC, SAS, XML) mean the study record is genuinely yours — ready for publication, for a sponsor hand-off, or for the next grant, not locked in someone's spreadsheet.
Big vendors treat a single academic study as a rounding error
A partner that stays in touch
Productive in days with customer care in touch throughout, not just at onboarding — and client feature requests genuinely reach the roadmap, whatever the size of your program.
Cost fit for a single grant-funded study
Spreadsheets & paper
Free, but not validated
Flex Databases
Scoped and priced for one study
Enterprise CTMS
Priced for a portfolio you don't have
Validation & audit readiness
Spreadsheets & paper
None — built by hand
Flex Databases
Pre-validated, 21 CFR Part 11
Enterprise CTMS
Validated, but months to configure
Time to first enrolled subject
Spreadsheets & paper
Immediate, but fragile
Flex Databases
2–4 weeks
Enterprise CTMS
6–12 months
IT or validation staff required
Spreadsheets & paper
None, but no compliance either
Flex Databases
None — validated out of the box
Enterprise CTMS
Dedicated IT team usually expected
Full eClinical stack
Spreadsheets & paper
Separate tools to fund
Flex Databases
CTMS, eTMF, EDC, PV, LMS in one
Enterprise CTMS
Broad, but heavy and costly
Data portability for publication
Spreadsheets & paper
Manual, error-prone
Flex Databases
One-click CDISC, SAS, XML exports
Enterprise CTMS
Available, often services-gated
| Spreadsheets & paper | Flex Databases | Enterprise CTMS | |
|---|---|---|---|
| Cost fit for a single grant-funded study | Free, but not validated | Scoped and priced for one study | Priced for a portfolio you don't have |
| Validation & audit readiness | None — built by hand | Pre-validated, 21 CFR Part 11 | Validated, but months to configure |
| Time to first enrolled subject | Immediate, but fragile | 2–4 weeks | 6–12 months |
| IT or validation staff required | None, but no compliance either | None — validated out of the box | Dedicated IT team usually expected |
| Full eClinical stack | Separate tools to fund | CTMS, eTMF, EDC, PV, LMS in one | Broad, but heavy and costly |
| Data portability for publication | Manual, error-prone | One-click CDISC, SAS, XML exports | Available, often services-gated |
What Support Actually Includes
Not a ticket queue — the people who understand academic and IRB context, not just commercial trials.
A named implementation lead
One person who understands your protocol, not a rotating queue of unfamiliar reps.
Response times that matter before a deadline
Clear response expectations for anything blocking a monitoring visit or an IRB submission.
Training built for rotating staff
Not a one-time session — a resource that's there whenever a new student or resident joins.
A say in what gets built next
Feature requests go to the product team and get reviewed — not filed away and forgotten.
The questions academic teams actually ask before switching
““Our grant budget is tiny compared to a pharma trial — can we even afford this?””
Priced for one study, not a portfolio
Modules are scoped and priced for a single investigator-initiated trial, not an enterprise contract sized for a commercial trial portfolio.
““We don't have anyone who can validate new software.””
Nothing for your team to build or certify
The platform arrives pre-validated to 21 CFR Part 11, so your research unit never has to run its own validation project.
““Will our IRB accept data from a system they've never seen?””
The same standard IRBs already recognize
21 CFR Part 11 validation, ISO 9001 and ISO 27001 certification are the same compliance bar commercial trials already use — familiar ground for most IRBs and auditors.
““What happens when our coordinator graduates or leaves?””
Fast enough for a one-day handover
Training is scoped to be quick, and a new coordinator can pick up an existing study without rebuilding its setup from scratch.
Moving Off Spreadsheets, Without Disrupting an Active Study
Most academic teams aren't switching from another CTMS — they're switching from spreadsheets and email. Here's the usual path.
1
STEP 1
Start with your next protocol
Most academic teams begin with a new or upcoming study, rather than migrating years of completed trial records.
2
STEP 2
Existing records move at your pace
If historical data from a closed-out study needs to be archived or referenced, it's brought over as a small, scoped project.
3
STEP 3
Nothing goes live unchecked
Migrated data is verified before your team relies on it for an active study.
Organizations of every size run on Flex
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
Simplicity
As a boutique organization, being able to add modules step by step matters more than a giant feature list.
Claudia Gruber
Director Clinical Operations, Sourcia
Self-service reporting
Building custom reports without a developer ticket is a major advantage for a lean team.
Tameo Kobayashi
Chief Innovation Officer, CMIC Holdings
Fair pricing
Being able to add modules only when needed, combined with clear and fair pricing, made the decision easy.
Michael Städele
Director, Business Development & Operations, WSG
Recent partnership stories
A few of the organizations that recently chose Flex Databases, in their own words.
Frequently asked by academic teams
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.