
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.
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.
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.
Schedule a DemoKey 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 SolutionsElectronic 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.
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.
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.
eConsent
Simplify patient enrollment and informed consent with digital eConsent software built for decentralized and remote clinical trials.
Post Market Surveillance
Conduct post-market surveillance and Phase IV studies with acloud-based pharmacovigilance software platform built for compliance.
EMR/EHR
Link electronic medical records to your clinical trial EDC with an EHR system and EMR software built for seamless data management.
Trial Design
Work with our expert clinical trial design team to implement your study protocol and train your users to build studies independently.
Data Management
Our clinical data management team supports your data cleaning, workflows for clinical trials, and study-specific needs from startup to close.
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.
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