Clean, Inspection-Ready Documents From Day One
Automate document filing, track completeness in real time, and maintain a single inspection-ready electronic trial master file through closeout. Medrio eTMF, powered by Engility®, is the compliance solution that connects directly to Medrio EDC and CTMS.
Your electronic trial master file should do more than store documents.
Automatically flag missing documents and expiry dates so your eTMF is always complete, current, and audit-ready.
Share data between Medrio eTMF and CTMS to reduce duplication and automate document routing across your study.
Provide selective, controlled access to external auditors to streamline inspections without compromising your data integrity.
Eliminate data silos with one connected trial ecosystem
Use integrations to eliminate fragmented data. Medrio connects documents to CTMS workflows and study processes.
Streamline trial and document management with automations for monitoring, enrollment, payments, and quality oversight.
Collaborate securely across sponsors, CROs, and sites
A secure cloud environment improves collaboration between sponsors, CROs, and sites.
Protect sensitive study data at every stage with an eTMF that adapts to your operating model with enterprise-grade security and role-based permissions.
Trusted by clinical teams
Recognized across the industry as the best EDC solution on G2.
“We have been using Medrio for a while now, and what truly stands out is the caliber of their employees. Every interaction, from initial setup to day-to-day support, has been marked by an exceptional level of professionalism.”
From planning to closeout and beyond
One platform to run leaner, faster, audit-ready clinical trials.
Improve data quality, engagement, and retention with a patient-centric solution.
Optimize supply chain with self-service randomization and inventory management.
Unify site monitoring, compliance, and clinical operations in one audit-ready workspace.
Automate document filing and compliance tracking to stay audit-ready from day one.
Meet the highest compliance standards
Ready to see Medrio?
Book a live, personalized demo to see for yourself why
clinical trial leaders trust Medrio.
Frequently asked Medrio eTMF questions
How do I evaluate & choose the best eTMF software vendor?
The best eTMF systems in 2026 have evolved from digital filing cabinets into active oversight tools. When evaluating eTMF software vendors, mid-sized biotechs should weigh the “enterprise burden” of legacy providers against Medrio’s focus on agile efficiency. Look for a partner that prioritizes speed and control, allowing for a faster go-live and intuitive document management without the heavy manual service models or rigid configurations of older systems.
What is the difference between a Trial Master File (TMF) and an Electronic Investigator Site File (eISF)?
An eISF is used for site-specific documentation. The TMF is used by the Sponsor (or CRO on behalf of the Sponsor) to store all of the essential trial files. This includes some documents that are also stored in an ISF.
Medrio’s eTMF does not have any ISF capabilities. However, with the appropriate permissions, sites can upload study pertinent documents to the eTMF, usually in a centralized folder that restricts who can see or access what documents within that and other locations.
Why is Medrio among the best eTMF vendors in 2026?
While legacy giants like Veeva Vault eTMF offer robust features, they often come with high overhead and complexity. Medrio is the right-sized eTMF partner for organizations seeking agile, modern solutions with streamlined workflows. We provide the same regulatory depth as enterprise systems but with an intuitive user experience. This allows clinical ops leads to manage the system themselves with confidence.
How does Medrio eTMF integrate with Medrio CTMS?
Modern clinical buyers prioritize top systems integrating eTMF and regulatory data workflows to ensure a unified flow. Medrio’s eTMF and CTMS share global setup information, such as contract information and site information. This allows for faster setup time in both modules.
Is Medrio an effective eTMF solution for smaller biotechs & CROs?
Yes. Medrio offers affordable eTMF solutions by eliminating unnecessary features and costs associated with larger competitors. Instead, our model features transparent, scalable eTMF pricing that fits your study’s budget constraints.
Does Medrio eTMF ensure compliance with ALCOA-C and 21 CFR Part 11 / Annex 11?
Foundational eTMF compliance is a non-negotiable requirement for an FDA audit of clinical trials. Medrio goes beyond industry best practice to strictly enforce ALCOA-C clinical research principles. To meet FDA 21 CFR Part 11 and EU Annex 11 standards, our system provides an audit trail to ensure total data integrity during global regulatory inspections.
How does Medrio eTMF support inspection readiness?
Medrio eTMF helps you track the health and completeness of your clinical trial. Host an FDA or EMA auditor at a moment’s notice with total confidence in your document completion.
What is the timeline for eTMF implementation?
The initial setup of Medrio eTMF takes approximately a week. Setup for subsequent studies can be completed in a matter of days.