Flex EDC for Faster & Smarter Study Setup and Connected Data Capture
Smarter trials, faster outcomes. A fully integrated, scalable Electronic Data Capture platform with built-in RTSM, ePRO and RBM, ready to launch in just 3 weeks.
Under 3 wks
typical study launch
500k+
subjects, supported in one study
100+
Life Sciences teams
21 CFR 11
validated
A Tuesday, before vs. after
Data manager writes eCRF specs for a developer to buildeCRFs built visually, with no code, and available in test mode the same day
Randomization runs through a separate RTSM vendor and contractRTSM is built in – no separate integration needed
Medical coding done manually against WHODrug and MedDRA, line by lineAI proposes codes for coder review – reducing repetitive entry
Designed to Support Regulated Clinical Data Capture
Core controls such as audit trails, electronic signatures, versioning, role-based access and validation documentation are included as standard.
"Flex Databases system is very flexible and user friendly. In addition, most importantly the team have 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, CMIC Holdings
"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.
PV system and digitalization was implemented due to one of our client’s needs, and considering the expectation of an important number of safety cases to be managed in this particular project. We selected Flex Databases due to a good cost-benefit and also due to the easy integration with Clinergy’s EDC system.
Suyh Lin
Clinical Project Manager at Clinergy Health Research
Flex Databases system is very flexible and user friendly — the team also has flexible ways of thinking.
Ulrike Schorr-Neufing
Director, ABX-CRO
Your EDC Shouldn’t Delay the Start of Your Trial
Flex EDC replaces the months-long build cycles and bolted-on RTSM and ePRO integrations that data teams currently juggle — with one platform that launches in weeks, not quarters.
Why Flex EDC?
We’ve built clinical trial software since 2011. Flex EDC brings that experience to data capture, supporting studies that launch in weeks, scale to 500,000+ subjects and share data across connected systems. More than 100 teams in 30+ countries use Flex, with support in the US, Europe and Asia.
A typical EDC build eats a whole quarter before the first patient is in
Typical study launch in under 3 weeks
Expert onboarding can take a study from kickoff to first data entry in under three weeks; one client reduced study build time by over 40% and launched in 21 days.
Every eCRF change waits in a programmer’s queue
Zero-code study build
eCRFs are built with drag-and-drop by your own data managers, and mid-study amendments follow the same approach – without a developer ticket or vendor-led change request.
Randomization and ePRO usually mean separate vendors, contracts and integrations
RTSM, ePRO and RBM built in
Randomization, trial supply, patient-reported outcomes and risk-based monitoring are available within the same EDC – reducing integration work and vendor management.
Medical coding done line by line against WHODrug and MedDRA
AI-assisted medical coding
AI proposes codes for coder review, reducing repetitive entry and supporting more consistent coding on the dictionaries your team already uses.
Platforms that demo well strain when subject counts get serious
Demonstrated at 500,000+ subjects
Flex EDC supports single studies with more than half a million subjects, together with multilingual support for global sites – enabling scale without changing platforms.
Getting data out for biostatistics becomes its own export project
One-click CDISC SDTM, SAS and XML exports
Standards-ready exports are available without a professional services request, giving biostatistics teams data in CDISC SDTM, SAS and XML formats.
A standalone EDC means re-entering every SAE into safety manually
Connected with CTMS, eTMF and PV
EDC shares a platform with safety, CTMS and eTMF. An SAE entered once can flow to pharmacovigilance without re-entry, while study documents can be filed automatically.
Enterprise-grade usually comes with an enterprise-grade invoice
Enterprise capability, sensible cost
Enterprise-grade EDC capabilities without enterprise-suite complexity or cost. You pay for the modules you use.
Weeks of vendor training before a site can enter its first CRF
Intuitive from day one, with people behind it
Sites and investigators are entering data within days, not weeks – and our customer care team stays in touch throughout the study, not just during onboarding.
Time to first patient in
Budget EDC tools
Fast, but features run out mid-study
FLEX EDC
Typical study launch in under 3 weeks
Legacy enterprise EDC
3–6 months of build and UAT
RTSM, ePRO, RBM
Budget EDC tools
Not available or third-party
FLEX EDC
Built into the same system
Legacy enterprise EDC
Separate modules, separately priced
Mid-study eCRF changes
Budget EDC tools
Risky, often manual
FLEX EDC
Drag-and-drop by your own team
Legacy enterprise EDC
Change order to the vendor
Medical coding
Budget EDC tools
Manual
FLEX EDC
AI-assisted, human-reviewed
Legacy enterprise EDC
Available, usually a paid add-on
Connection to safety & TMF
Budget EDC tools
Export and re-enter
FLEX EDC
Same platform, no re-entry
Legacy enterprise EDC
Integration project per system
| Budget EDC tools | FLEX EDC | Legacy enterprise EDC | |
|---|---|---|---|
| Time to first patient in | Fast, but features run out mid-study | Typical study launch in under 3 weeks | 3–6 months of build and UAT |
| RTSM, ePRO, RBM | Not available or third-party | Built into the same system | Separate modules, separately priced |
| Mid-study eCRF changes | Risky, often manual | Drag-and-drop by your own team | Change order to the vendor |
| Medical coding | Manual | AI-assisted, human-reviewed | Available, usually a paid add-on |
| Connection to safety & TMF | Export and re-enter | Same platform, no re-entry | Integration project per system |
Every part of the EDC, in plain terms
Flex EDC includes powerful modules tailored to each role in the clinical study — six capability areas, connected by default.
eCRF builder — no coding needed
Build eCRFs visually using templates and logic tools. Apply adaptive design, triggers and hidden forms for complex protocols, preview and test forms in a validation environment, and update workflows mid-study without needing IT support.
Visual, drag-and-drop eCRF design
Instant preview and validation in test mode
Preview and testing in validation mode
Mid-study workflow updates, no IT ticket
Site & investigator experience
Role-based dashboards give sites and monitors the information they need. Visit and subject planning tools, autofill fields and query templates reduce repetitive work, while enrollment and data quality remain visible in real time.
Role-based dashboards
Autofill fields and query templates
Visit and subject planning
Real-time enrollment and data quality tracking
RTSM — built right in
Randomization and trial supply management are built into the same platform. Apply block, stratified, minimization or custom randomization, manage drug inventory with automated resupply triggers, and support controlled mid-study changes.
Block, stratified, minimization or custom randomization
Automated resupply triggers
Drug inventory control
Controlled mid-study changes
ePRO — real-time patient engagement
Branded mobile and web pages with offline access let patients report outcomes directly. Forms can be triggered through EDC edit checks, reminders support completion, and wearables and multilingual surveys broaden data collection.
Branded mobile and web pages, offline-capable
Smart patient reminders
Forms triggered by EDC edit checks
Wearable integration and multilingual surveys
RBM & dashboards
Visualize KPIs and metrics across the study. Monitor 26+ risk signals and data quality indicators, configure reports for internal teams and regulators, and export supporting data for review.
Study-wide KPI visualization
26+ risk and data quality indicators
Custom reports for teams and regulators
Exportable data for review and audit support
Controls for Regulated Data Capture
Protocols, consents and regulatory files remain under version control. Medical coding supports WHODrug, MedDRA, ATC and ICD, while annotated eCRFs and standards-ready exports can be generated from the system
Version control for protocols and consents
One-click annotated eCRFs
WHODrug, MedDRA, ATC and ICD coding
Standards-ready exports
One Platform That Grows With You
Add studies, sites, countries and thousands of subjects, 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
Run every study — phase I through post-marketing — on the same EDC, with cross-study oversight instead of one login per protocol.
Connects to what you already run
Flex EDC supports integration with common CTMS, eTMF, safety, BI and statistics systems, helping data flow where it is needed without repeated entry.
Access built around your org chart
Data managers, monitors, investigators and sponsors each see exactly what their role needs — by study, site or country — not one shared login for everyone.
Onboarding that scales with your team
A named implementation lead guides the first study through setup and onboarding, with typical launch in under 3 weeks. The same platform supports additional studies, countries and users.
Fits Into Your Stack, Live in Weeks
Keep established systems in place while Flex EDC supports the data flows between them.
Every system you already depend on
Flex EDC supports integration with common clinical and enterprise systems, while ePRO and RTSM are available within the platform.
- Safety / pharmacovigilance — SAEs flow without re-entry
- CTMS and eTMF — same platform, same data model
- Biostatistics — instant CDISC SDTM, SAS, XML exports
- ePRO and RTSM — already inside, nothing to integrate
- Safety and pharmacovigilance databases
Accessible anywhere, with typical launch in under 3 weeks
Cloud by default, on-premise if your policy requires it — either way, sites and monitors just open a browser and work. No client software to manage, no manual updates to schedule.
HOSTING
Cloud or on-premise
ACCESS
Any browser, any device
SUPPORT
Named implementation lead
3 weeks
Typical kickoff-to-launch timeline under 3 week
EDC Problems That Quietly Slow Down Every Trial
These problems rarely appear as a single failure. Instead, they add delay to study setup, data review and downstream reporting.
Building an eCRF means a spec doc and a developer queue
Turning a protocol into a working case report form usually means writing a specification, handing it to a developer, and waiting for a build cycle — before a single subject can be entered.
COST
Weeks lost before the study can even start collecting data
Randomization, ePRO and risk monitoring sit in three different contracts
RTSM, patient-reported outcomes and risk-based monitoring often come from three separate vendors, each with its own integration project, its own login, and its own point of failure.
COST
Three vendor relationships to manage instead of one
Some EDC platforms struggle as enrollment scales
Systems designed for small trials can become difficult to operate as enrollment grows, creating pressure for disruptive mid-study changes or migration
COST
Coder hours that scale linearly with enrollment
Getting data to statisticians means a custom export project
Without native CDISC support, getting trial data into a format biostatistics can actually use means a mapping exercise every time a submission deadline approaches.
COST
Last-minute export work that delays submission-ready data
Recognize more than two of these?
That’s usually the point where a connected EDC can begin to pay for itself across study setup and operations.
How EDC Software Fixes It: One Platform Instead of Four Vendor Contracts
Each problem above maps directly to something the platform does differently — not a feature list, a fix.
The Problem
eCRF builds need a developer and a spec document
What changes with Flex EDC
Zero-code eCRF builder, live in test mode the same day
The Problem
RTSM, ePRO and RBM live in three separate contracts
What changes with Flex EDC
Built in directly — no separate integrations needed
The Problem
Studies capped by the system's scale
What changes with Flex EDC
Scales to 500,000+ subjects in a single study
The Problem
Medical coding done manually, line by line
What changes with Flex EDC
AI proposes WHODrug, MedDRA, ATC and ICD codes for human review
The Problem
Data export needs a custom mapping project
What changes with Flex EDC
One-click export to CDISC SDTM, SAS and XML
| The Problem | What changes with Flex EDC |
|---|---|
| eCRF builds need a developer and a spec document | Zero-code eCRF builder, live in test mode the same day |
| RTSM, ePRO and RBM live in three separate contracts | Built in directly — no separate integrations needed |
| Studies capped by the system's scale | Scales to 500,000+ subjects in a single study |
| Medical coding done manually, line by line | AI proposes WHODrug, MedDRA, ATC and ICD codes for human review |
| Data export needs a custom mapping project | One-click export to CDISC SDTM, SAS and XML |
Built for Sponsors, CROs, Sites & Patients
One platform, with role-based experiences for each group.
Sponsors & CROs
•
Track trial progress with clear status indicators
•
Assign roles and access with predefined or custom settings
•
Export data to support submission timelines
•
Oversee documentation and version control at every step
Sites & Investigators
•
Navigate an intuitive interface with minimal training
•
Validate entries using auto-calculations and logic
•
Enroll subjects and manage visit schedules within the same study workflow
•
Resolve queries quickly using prebuilt templates
Patients
•
Use app-based diaries to enter study data
•
Receive timely reminders to stay engaged
•
Understand surveys with multilingual support
•
Sync data with the study database
“We reduced study build time by over 40% and launched our trial in 21 days using Flex EDC. The built-in RTSM and real-time dashboards made a real difference.”
A Closer Look, By Area
Explore the workflows most relevant to data teams, investigators and patients.
•
Supports large studies – demonstrated with 500,000+ subjects in one study
•
Visual eCRF creation
•
Role-based access configuration
•
Built-in medical coding: WHODrug, MedDRA, ATC and ICD
•
Export to CDISC SDTM, SAS and XML
•
Smart search within EDC
•
Status indicators for rapid process review
•
Templates for raising queries
•
Controls supporting ICH GCP E6(R2), 21 CFR Part 11, HIPAA and GAMP 5-aligned validation
•
Full-trial KPI report
What Actually Changes in Week One With Flex EDC
Not spreadsheets — what a switch from another EDC platform actually looks like.
| Task | Typical EDC platform | Flex Databases EDC |
|---|---|---|
| Getting a new site entering data | Formal vendor training, weeks to proficiency | Sites entering their first CRFs within days |
| Adding a site mid-study | Change request, vendor timeline | Configured by your team, no development request |
| Building a custom data listing | Professional services quote required | Built by your data manager, no services quote |
| Running a study in three languages | Separate builds or costly localization | Multilingual support in the same study |
| Getting a straight answer from support | Ticket queue, SLA measured in days | Direct line to a named implementation lead |
Task
Getting a new site entering data
Typical EDC platform
Formal vendor training, weeks to proficiency
Flex Databases EDC
Sites entering their first CRFs within days
Task
Adding a site mid-study
Typical EDC platform
Change request, vendor timeline
Flex Databases EDC
Configured by your team, no development request
Task
Building a custom data listing
Typical EDC platform
Professional services quote required
Flex Databases EDC
Built by your data manager, no services quote
Task
Running a study in three languages
Typical EDC platform
Separate builds or costly localization
Flex Databases EDC
Multilingual support in the same study
Task
Getting a straight answer from support
Typical EDC platform
Ticket queue, SLA measured in days
Flex Databases EDC
Direct line to a named implementation lead
Why This EDC Software 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 account runs on the same platform, configured per study instead of re-platformed per client — so onboarding a new account is weeks, not months, and margins stay intact.
Sponsors
Sponsors can own the instance, allowing oversight and audit history to persist across CRO changes, with live portfolio visibility across studies.
Academic & research institutions
Investigator-initiated and multi-site academic trials 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
10000
Projects
40+
Countries
Frequently asked about EDC 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.