A Better Way to Manage Trial Documentation

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ELECTRONIC TRIAL MASTER FILE (eTMF) SOFTWARE

Automatically file and organize trial documents

Track completeness, missing docs, and expirations in real time

Stay inspection-ready without manual effort

Medrio’s eTMF software, powered by Engility®, goes beyond document storage. It acts as your compliance solution, automating filing, maintaining completeness, and keeping your study inspection-ready.

See how easy Medrio eTMF is to set up and run

SurveyRight vs. DIY Tools

VALIDATED CONTENT

GENERIC FORMS

THIRD-PARTY CANDOR

INTERNAL BIAS CONCERNS

DRIVER-RANKED PRIORITIES

ISOLATED SCORES

BENCHMARKS & TREND VIEWS

STATIC RESULTS

MANAGED DELIVERY

HEAVY INTERNAL LIFT

Frequently asked questions

FAQ Accordion

1 How do I evaluate & choose the best eTMF software vendor?

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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.

2 What is the difference between a Trial Master File (TMF) and an Electronic Investigator Site File (eISF)?

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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.

3 Why is Medrio among the best eTMF vendors in 2026?

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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.

4 How does Medrio eTMF integrate with Medrio CTMS?

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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.

5 Is Medrio an effective eTMF solution for smaller biotechs & CROs?

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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.

6 Does Medrio eTMF ensure compliance with ALCOA-C and 21 CFR Part 11 / Annex 11?

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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.

7 How does Medrio eTMF support inspection readiness?

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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.

8 What is the timeline for eTMF implementation?

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The initial setup of Medrio eTMF takes approximately a week. Setup for subsequent studies can be completed in a matter of days.

Medrio EDC is quick , secure and reliable EDC Platform with much customization options and custom report creation , faster report download and also UI is easy and smooth to navigate

Pratik K.
Clinical Data Associate

Keep your trial master file complete, organized, and compliant at all times.

POWERING TRIALS FOR EMERGING INNOVATORS

Most life sciences teams are stuck with two options:

THE PROBLEM

Medrio simplifies eTMF management

THE SOLUTION

Stay audit-ready from day one

CONTINUOUS INSPECTION READINESS

Mitigate risk with a comprehensive trial master file that automatically tracks missing documents, version history, and expiration dates.

Reduce duplication and manual work

UNIFIED CLINICAL WORKFLOWS

Connect eTMF directly with CTMS workflows, linking documents to study activities and eliminating redundant data entry.

Make audits faster and easier

AUDITOR-FRIENDLY ACCESS

Provide secure, role-based access to auditors and external stakeholders to streamline reviews with controlled visibility.

Replace manual filing with structured automation

AUTOMATED REGULATORY COMPLIANCE

Standardize document organization and automate filing to reduce compliance risk with an accurate trial master file.

There's a lot of useful 'tricks' in the system that I hadn't expected that will really make day-to-day tasks much easier. The making of the EDC has been an easy process and the team has made this experience 10x easier for us.

Stay inspection-ready

See Medrio in action with a live demo.

-Sydney C.
Clinical Data Manager

9.6k+

83%

98%

65%

Studies deployed globally

Faster mid-study changes

Faster study builds

Of teams stay with Medrio

Upholding the highest compliance standards