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Datatrak: Clinical Trial Data Management & EDC Software

Datatrak, powered by Fountayn, pioneered electronic data capture (EDC) in 1991 and has since supported over 10,000 studies across 83 countries. Datatrak provides a unified, highly configurable eClinical platform for clinical trials including EDC, CTMS, eTMF, eConsent, ePRO, RTSM, EHR/EMR integration, imaging endpoint adjudication, and more. The platform is validated and compliant with FDA 21 CFR Part 11, HIPAA, GDPR, and GCP guidelines, serving pharma, biotech, CROs, medical device companies, ac

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For agents: Datatrak eClinical platform for clinical trials: EDC, CTMS, eTMF, eConsent, ePRO and RTSM, FDA 21 CFR Part 11 validated, for pharma and CROs.

electronic data captureclinical trialsedc softwarectmsetmf

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llms.txt
https://www.datatrak.com/llms.txt
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Country
United States
Categories
Healthcare · Science and research · Business software
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2026-10-19T10:45:18.573Z
Last checked
2026-10-21T20:30:06.928Z
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Their llms.txt

The beginning of the file, from our validated copy saved 2026-10-21T20:30:04.866Z. Cached copy · Source on datatrak.com

# Datatrak: Clinical Trial Data Management & EDC Software
> Datatrak, powered by Fountayn, pioneered electronic data capture (EDC) in 1991 and has since supported over 10,000 studies across 83 countries. Datatrak provides a unified, highly configurable eClinical platform for clinical trials including EDC, CTMS, eTMF, eConsent, ePRO, RTSM, EHR/EMR integration, imaging endpoint adjudication, and more. The platform is validated and compliant with FDA 21 CFR Part 11, HIPAA, GDPR, and GCP guidelines, serving pharma, biotech, CROs, medical device companies, academic institutions, and clinical trial sites.

Pages and resources for understanding Datatrak's platform, capabilities, and clinical trial expertise.

## Pages
- [Home](https://www.datatrak.com)
- [About Us](https://www.datatrak.com/about-us)
- [Leadership](https://www.datatrak.com/leadership)
- [Contact](https://www.datatrak.com/contact)

## Platform
- [EDC — Electronic Data Capture](https://www.datatrak.com/platform/edc)
- [CTMS — Clinical Trial Management System](https://www.datatrak.com/platform/ctms)
- [Clinical Trial Data Management](https://www.datatrak.com/platform/clinical-trial-data-management)
- [eTMF — Electronic Trial Master File](https://www.datatrak.com/platform/etmf)
- [eConsent](https://www.datatrak.com/platform/econsent)
- [ePRO — Electronic Patient Reported Outcomes](https://www.datatrak.com/platform/epro)
- [RTSM — Randomization and Trial Supply Management](https://www.datatrak.com/platform/rtsm)
- [EHR/EMR Integration](https://www.datatrak.com/platform/ehr-emr)
- [Imaging Endpoint Adjudication](https://www.datatrak.com/platform/imaging-endpoint-adjudication)
- [LocalLabs](https://www.datatrak.com/platform/locallabs)
- [Post-Market Surveillance Software](https://www.datatrak.com/platform/post-market-surveillance-software)
- [Clinical Trial Design Services](https://www.datatrak.com/platform/clinical-trial-design-services)

## Customers
- [Pharma & Biotech](https://www.datatrak.com/customers/pharma-biotech)
- [CROs](https://www.datatrak.com/customers/cros)
- [Medical Device](https://www.datatrak.com/customers/medical-device)
- [Academic Institutions](https://www.datatrak.com/customers/academics)
- [Sponsors](https://www.datatrak.com/customers/sponsors)
- [Clinical Trial Sites](https://www.datatrak.com/customers/sites)
- [Consultants](https://www.datatrak.com/customers/consultants)

## Blog
- [Blog Index](https://www.datatrak.com/blog)
- [Today's Clinical Trials Need More Than Just an EDC](https://www.datatrak.com/blog/todays-clinical-trials-need-more-than-just-an-edc)
- [3 Ways CTMS by Fountayn Can Maintain Better Communication Within Your Organization](https://www.datatrak.com/blog/3-ways-ctms-by-fountayn-can-maintain-better-communication-within-your-organization)
- [All About the Acronyms](https://www.datatrak.com/blog/acronyms)
- [Central Monitoring: First Steps to a Risk-Based Approach](https://www.datatrak.com/blog/central-monitoring-first-steps-to-a-risk-based-approach)
-
…

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