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Electronic Trial Master File (eTMF)

Datatrak’s eTMF system removes the friction of disconnected tools and extra logins by working directly within the EDC environment. Teams can manage document sharing, upload requests, permissions, and workflow participation from the EDC dashboard, which keeps trial documentation moving without adding administrative drag.

Behind the experience is a Part 11 compliant eTMF built on standardized terminology from the eTMF Reference Model. Documents, workflows, and metadata are centrally managed, version controlled, indexed, and backed by compliant audit logs.

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Switching Is Easy with Little Onboarding

Users don’t need to transition or learn a new eTMF system because they can access eTMF through the EDC dashboard. Central manager roles at the Sponsor or CRO determine site user access.

FDA CFR 21 Part 11 Compliant eTMF System

Fountayn’s eTMF system is fully Part 11 compliant and validated.

62% Average Cost Savings

Switching provides a 62% cost savings on average when compared to other eTMF systems.

Average Cost Savings of 62%

Switching to Fountayn eTMF Is Easy with Minimal Onboarding

Switching from another eTMF solution to Fountayn is easy because site personnel can send, receive, and approve eTMF documents from EDC dashboards, significantly reducing the onboarding process. Regulatory inspection friendly with audit settings to tailor the viewable documents to information necessary and data definitions. Document data and workflows have settings for Quality Control, Certified Copy, Document Request, and more.

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Key Capabilities

Seamlessly integrated with EDC — no additional logins required
Part 11 compliant with audit logs and version-controlled documents
Documents searchable and exportable in RM-conforming formats
Regulatory inspection-friendly audit settings
Quality Control, Certified Copy, and Document Request workflows

Integrated Solutions

View All Solutions

Electronic Data Capture (EDC)

A powerful, cost-effective EDC system that enhances data capture and cleaning with a Rapid Startup option — easy to set up and built for any study.

Explore EDC Software →

Clinical Trial Management (CTMS)

Manage your clinical trials from startup to close with a fully integrated CTMS giving your team real-time visibility across all studies.

Explore our CTMS →

Electronic Trial Master File (eTMF)

Keep every trial document compliant and inspection ready with an eTMF system that cuts costs by 62% and integrates directly with EDC.

Explore ETMF Software →

eConsent

Simplify patient enrollment and informed consent with digital eConsent software built for decentralized and remote clinical trials.

Explore EConsent Software →

Post Market Surveillance

Conduct post-market surveillance and Phase IV studies with a cloud-based pharmacovigilance software platform built for compliance.

Explore PMS Software →

EMR/EHR

Link electronic medical records to your clinical trial EDC with an EHR system and EMR software built for seamless data management.

Explore EHR Systems →

Trial Design

Work with our expert clinical trial design team to implement your study protocol and train your users to build studies independently.

Explore trial design services →

Data Management

Our clinical data management team supports your data cleaning, workflows for clinical trials, and study-specific needs from startup to close.

Explore Data Management →

"Datatrak is the best of breed products suite assisting in any clinical trials from simple to complex studies abroad oncology therapeutic area. It provides high speed connectivity for both sponsor and site users to enter eCRFs in a timely manner on intuitive UIs. The products have the capacity to allow pharmaceutical companies, CROs and Academic Institutes to build any type of clinical trials easily. It brings in cost efficiency and all features and built in a single platform. Datatrak is a powerhouse vendor in the health care industry."

Tsubasa Iwata — ClinCloud

We have been using Datatrak EDC for clinical data management for the past 10 years. It has been great working with the Datatrak team, their customer support always responds promptly and is super helpful. The system is easy to use, you can create customized forms, manage study participants, securely store and manage data.

Shannon Stoddard — Oculos

We have been using Datatrak for about 7 years now for our studies, and we selected Fountayn for several reasons. Basic functions to complex solutions are integrated into the same tool. It is user friendly, and site staff with experience know perfectly how to enter data, resolve queries, and more. Datatrak is friendly when exporting data to conduct statistical analysis. We have never had any downtimes or issues in our operations, and most importantly, we have never lost any data.

Alejandro Arias — CEO, ILS Clinical Research

We used Datatrak EDC to support a complex double-blind clinical trial, including custom randomization, a site-specific sub-study, and external imaging data entry. The platform handled edit checks and data validation reliably, with strong audit trails supporting compliance requirements. Its flexibility allowed us to adapt quickly as study needs evolved. We completed database lock on time with all SDV, and query resolution finalized, which speaks to both the system's robustness and how quickly our teams got productive on it.

Sandeep Saha — Director of Data Science, Cardiovascular Clinical Sciences

Frequently Asked Questions

What is an eTMF (electronic trial master file)?

An eTMF is the electronic repository for the documents, workflows, and metadata that demonstrate a clinical trial was conducted according to regulatory standards. Datatrak’s eTMF system is a Part 11 compliant document repository with compliant audit logs and standardized terminology following the eTMF Reference Model, with documents, workflows, and metadata that are version controlled, centrally managed, and indexed.

How easy is it to switch to Datatrak’s eTMF from another system?

Switching is easy with minimal onboarding because users access eTMF directly through the EDC dashboard. Site personnel can send, receive, and approve eTMF documents without learning a separate system or managing additional logins. Central manager roles at the Sponsor or CRO determine site user access, and switching provides a 62% cost savings on average when compared to other eTMF systems.

Is Datatrak’s eTMF software ready for regulatory inspection?

Yes. Our eTMF system is fully FDA CFR 21 Part 11 compliant and validated, with audit logs and version-controlled documents built in. Regulatory inspection-friendly audit settings let you tailor the viewable documents to the information and data definitions required, and workflows for Quality Control, Certified Copy, and Document Request are all available inside the platform.