Electronic Data Capture

Smarter Trials. Faster Outcomes. All-in-one Electronic Data Capture with built-in RTSM, ePRO, and full compliance – ready in just 3 weeks and scalable up to 500,000 subjects.

EDC PDF

ISO 9001-2015 label certification new version

Why Flex EDC?

3-week average setup time – fast go-live with expert onboarding
Zero-code eCRF design – study build in minutes using drag & drop
RTSM included – no add-ons, with four randomization types out of the box
Up to 500,000 subjects supported – tested at scale
CDISC SDTM, SAS, XML exports – submission-ready from day one
Compliant by default – 21 CFR Part 11, GCP E6(R2), GAMP5, HIPAA
AI-powered medical coding to reduce time and errors
Multilingual study support for global trials
Version control for protocols, consents, and key study documents

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EDC_Demo_2

EDC_main_screen

Build your study and its eCRFs in a convenient easy-to-use tool in no time

Drag-and-drop eCRF builder
Calculations, validations, and logic setup
Instant preview and test mode

epro

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Get a clean, intuitive interface for sites and investigators

Role-based dashboards
Smart visit calendars and subject profiles
Query templates and autofill logic to reduce site burden

clinic

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Arrange randomization and trial supply management in a fully integrated system

Block, stratified, minimization, and custom randomization
Real-time stock control and resupply
Easy configuration per protocol needs

rtsm

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Provide your patients with a simple ePRO tool to get real-time patient-reported outcomes

Branded mobile app with offline mode
Smart notifications and reminders
Seamless connection to subject data

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Navigate your study based on the data-driven decisions with the reports available in one click

Study-wide KPIs and dashboards
Prebuilt and custom reports
Full audit trail and export filtering

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Built for Every Stakeholder

Sponsors and CRO’s

DSemaphore-based progress tracking
End-to-end audit trail and compliance
Role assignment in one click
Instant exports and submission readiness
Oversight of protocol versioning and documentation

Investigators and Sites

Intuitive UI with minimal learning curve
Automated calculations and validation to reduce entry errors
Rapid subject enrollment and tracking
Visit and form status overview in one screen
Fast query resolution via templates

Patients

Simplified, app-based diary experience
Smart reminders to improve compliance
Multilingual interface for global studies
Real-time syncing with study backend
High engagement through clean, user-focused design

Ready to See It in Action?

Let our team walk you through a personalized demo or send you a full product brochure.

video edc

Features

Unlimited clinical trial size – up to 500 000 subjects included in one study during beta testing
Prompt and easy eCRF creation
Distribution of roles in just one click
Built-in medical coding WHODrug, MedDRA, ATC, and ICD
Export to CDISC SDTM, SAS, XML, and Module

Smart search within EDC
Semaphore system to quick assessment of processes completion
Templates for raising queries
Compliance with GCP E6 R2, 21 CRF part 11, GAMP5, HIPAA
Full-trial KPI report

Fast access to the system through a dedicated portal for Investigators
Quick and clear data input
Easy to add subjects in the study

Calendar of visits for every subject and the trial in general
Templates to close queries in a few seconds
Simple navigation system with ability to find a subject in one click

ePRO App for patients to simplify diary maintenance
User-friendly & supportive interface and diary management process
Branding for mobile apps & website

Fast access to patient’s diary
Integration with wearable devices, such as fitness trackers and smart watches

What They Say About Us

Tameo Kobayashi

Chief Innovation Officer, Director, Business Innovation Dept., CMIC HOLDINGS Co., Ltd.

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.

Joshua Baisley, H.B.Sc.

VP, Clinical Design and Delivery

As we have begun the installation process for Flex Databases system for use with the Clinical Trial Management group, the team at Flex Databases have made this process efficient and organized along with answering any questions that come up internally and jumping on additional meetings with our team to ensure that everything is understood throughout the set up and training process.

John Douglas Snowden

Senior Vice President of Technology Innovation at NCGS, Inc.

NCGS has partnered with Flex to utilize nearly the entire suite of cloud-based modules Flex has to offer for the industry. NCGS believes in Flex’s vision for their platform as it so closely ties to our own ideals of uniformity and simplicity in operations and the delivery of true quality.

Craig Winter

CIO, Agenus Inc.

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.

Cheryl Marron

Manager Clinical Operations

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.

Ulrike Schorr-Neufing

Director Personnel & Qualification

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.

Martin Krauss

Director of FGK Clinical Research

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.

Simon Rückinger

Managing Director at Metronomia Clinical Research GmbH

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.

Lídice Vidal

Chief Clinical Օperations Officer

We have made a journey of almost two years now, since we were exploring new vendors to change our CTMS system in May 2022, until the deployment of the system last March 2024. It would not be possible without the kind and patient support of Flex team! All the team we have encountered during this time have listened attentively to our needs and doubts, have perfectly understood them, and have always provided us with new options and possible solutions.

100+

Clients

20 000+

Daily Users

10M+

Documents

2 000+

Clinical Trials

30+

Countries

Contact us

Get in touch to discuss compliance, implementation, demos, pricing

We are here for all of your questions! Tell us more about yourself and we will organize a tailored live demo to show how you can power up your clinical trials processes with Flex Databases.