Transform Clinical Trial Management with Fountayn eTMF
Smarter eTMF Starts Here
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Maintain 21 CFR Part 11 compliance with complete audit trails and RM-aligned metadata.
Adapt the eTMF architecture to any study with reusable templates and flexible folder configurations.
Automate QC, certified copy, and document request processes for faster, error-free execution.
Capture. Analyze. Accelerate.
Traditional eTMF systems can be rigid, complex, and costly. Fountayn’s Electronic Trial Master File (eTMF) software is designed to streamline clinical data collection, enhance flexibility, and ensure compliance—without the usual headaches
Faster Study Setup
Get your trials up and running in weeks, not months.
Intuitive Interface
Reduce training time and improve user adoption.
Real-Time Insights
Make data-driven decisions with instant access to study data.
Adaptive & Scalable
Adjust to your study needs without costly reconfigurations.
Fountayn is a powerhouse vendor in the health care industry.
“Fountayn is the best product suite assisting in any clinical trials – from simple to complex studies, even those in the oncology therapeutic area. It brings in cost efficiency and all features are built in a single platform.“
Tsubasa Iwata, Representative Director
Tsubasa Iwata,
Representative Director
What Makes Fountayn’s eTMF Different?
Our goal is to help our clients streamline trial document management with a system that is built around compliance, security, and scalability.
Aligned to the eTMF Reference Model
Fountayn’s eTMF reflects the structure and terminology of the DIA Reference Model and supports full Part 11 compliance. Standards for metadata and workflows are version-controlled and applied safely at the trial level.
Flexible, Study-Specific Design
The repository structure and metadata are fully customizable. Move, copy, delete, or reuse templates across studies—without disrupting live trials.
Built for Sponsors, CROs & Research Sites
Whether you’re managing a small-scale study or a global clinical trial, our eTMF for clinical trials adapts to your workflow – giving you full control over your data without the need for complex custom coding.
formerly Datatrak
Ready to Transform Your Data Management?
Take control of your clinical trials with a smarter, faster, and more intuitive eTMF system.
Loved by Customers
83 Countries • 6 Continents
Has made our jobs a lot easier.
“The team was great to work with and they made sure the eCRFs looked and worked well. It makes them an easy choice for EDC referrals.”
The speed is what we love here.
“Utilizing Randomization within their EDC makes it easier for the sites, providing a seamless process."
Traditional eTMF systems can be rigid, complex, and costly. Fountayn’s Electronic Trial Master File (eTMF) software is designed to streamline clinical data collection, enhance flexibility, and ensure compliance—without the usual headaches
Capture. Analyze. Accelerate.
Streamlined Oversight & Role-Based Access
Manage site-level documentation across teams with flexible user permissions. Tailor platform views for monitors, auditors, and inspectors to support regulatory inspections with confidence.
Audit-Ready, Searchable, and Integrated
Every document is versioned, indexed, and audit-logged. Search and export documents in RM format directly from the Fountayn platform—with full visibility from the EDC dashboard.
Faster Study Setup
Get your trials up and running in weeks, not months.
Intuitive Interface
Get your trials up and running in weeks, not months.
Real-Time Insights
Make data-driven decisions with instant access to study data.
Adaptive & Scalable
Adjust to your study needs without costly reconfigurations.
Ready to Transform Your Data Management?
Take control of your clinical trials with a smarter, faster, and more intuitive eTMF system.
Loved by Customers
83 Countries • 6 Continents
Has made our jobs a lot easier.
“The team was great to work with and they made sure the eCRFs looked and worked well. It makes them an easy choice for EDC referrals.”
The speed is what we love here.
“Utilizing Randomization within their EDC makes it easier for the sites, providing a seamless process."
10+ years of reliable clinical data management.
“The system is easy to use, you can create customized forms, manage study participants, securely store and manage data.”
Easy to switch. Built for compliance. Designed to simplify trial documentation.
formerly Datatrak
Switching to Fountayn is easy: send, receive, and approve eTMF documents from EDC dashboards