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Smarter Clinical Trials Start with Flex EDC

Smarter Trials. Faster Outcomes. All-in-One Electronic Data Capture (EDC) System. Accelerate your trials with a fully integrated, scalable platform that includes RTSM, RBM, ePRO, and real-time reporting – ready to launch in just 3 weeks.

EDC PDF
compliant with FDA
hiipa compliant
ich_logo_png
ISO 9001-2015 label certification new version
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ISO 27001_2022

Why Flex EDC?

  • Launch your study in under 3 weeks with expert onboarding
  • Design zero-code eCRFs using drag-and-drop and other smart tools
  • Leverage built-in RTSM, ePRO, and RBM – no integrations needed
  • Scale up to 500,000+ subjects with confidence
  • Export CDISC SDTM, SAS, and XML formats instantly
  • Maintain compliance with 21 CFR Part 11, GCP, HIPAA, and GAMP5
  • Automate medical coding with AI to save time and reduce errors
  • Multilingual study support for global trials
  • Version control for protocols, consents, and key study documents
EDC_Demo

EDC_Demo

EDC_Demo_2

EDC_Demo_2

EDC_main_screen

EDC_main_screen

Scalable by Design

Flex EDC includes powerful modules tailored to each role in the clinical study. 

Design Smarter eCRFs – No Coding Needed

  • Build eCRFs visually using templates and logic tools
  • Apply adaptive design, triggers, and hidden forms for complex needs
  • Preview and validate instantly with test mode
  • Update workflows mid-study – no IT support required
epro

epro

epro_1

epro_1

Streamline Site & Investigator Experience

  • Customize dashboards by role for targeted oversight
  • Manage visits and subjects with smart planning tools
  • Reduce site burden using autofill fields and query templates
  • Track enrollment and data quality in real time

clinic

clinic

Clinic_2

Clinic_2

Integrate RTSM – Built Right In

  • Apply block, stratified, minimization, or custom randomization
  • Control drug inventory and trigger automated resupply
  • Adapt mid-study without downtime or disruption
rtsm

rtsm

rtsm_1

rtsm_1

Engage Patients with Real-Time ePRO

  • Deploy branded mobile and web apps with offline access
  • Trigger forms through EDC edit checks for seamless data flow
  • Send smart reminders to improve patient involvement
  • Capture rich data via wearables and multilingual surveys
ePro_screenshot

ePro_screenshot

Monitor and Optimize with RBM & Dashboards

  • Visualize KPIs and metrics across your study
  • Detect anomalies with 26+ risk signals and fraud indicators
  • Customize reports for teams and regulators
  • Export clean, audit-ready data instantly

reporting_1

reporting_1

Stay Compliant by Design

  • Manage protocols, consents, and regulatory files with version control
  • Code with WHODrug, MedDRA, ATC, and ICD compliance
  • Generate annotated eCRFs and submission-ready exports in one click

Designed for Sponsors, CROs, Sites & Patients

Sponsors and CRO’s

  • Stay updated with trial progress with semaphore tracking
  • Assign roles and access with any of both options: predefined or custom roles settings
  • Export instantly to meet submission deadlines
  • Oversee documentation and version control at every step
Download PDF
Sites & Investigators

  • Navigate through an intuitive interface with minimal training
  • Validate entries using auto-calculations and logic
  • Enroll subjects and manage visit schedules effortlessly
  • Resolve queries quickly using prebuilt templates
Download PDF
Patients

  • Use easy, app-based diaries to enter daily data
  • Receive timely reminders to stay engaged
  • Understand surveys with multilingual support
  • Sync data instantly with the study backend
Download PDF

Compliance & Security

Flex EDC is validated and certified for:

compliant with FDA
cdisc
hiipa compliant
ich gcp
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Trusted Performance

“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.” 

Clinical Project Manager, Phase II Oncology Trial

Ready to See It in Action?

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

Features

EDC_Demo_2
  • 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
clinic
  • 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
rtsm_1
  • 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.

Solti_30aniv_Logo
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.