Agatha Clinical

A complete, ready-to-use, cloud-based application for managing essential Trial Master File (eTMF) documents and processes.

Agatha Clinical is a powerful application that connects sponsors, CRO staff, and site resources with automated processes for creating, managing, and tracking the Trial Master File (TMF).

Managing Clinical Trials is Complex

Clinical trials are complex projects, with multiple participants in multiple locations and different roles. That complexity is amplified by the process itself, which includes an extensive document creation, review, and approval process. To make it even more challenging, access to systems is often complicated by cumbersome IT processes.

Agatha Clinical provides an immediately-available solution that connects all trial participants and processes in a single, cloud-based application. Leveraging the TMF Reference Model, Agatha Clinical includes standard templates that ensure you get up and running quickly, reducing ramp-up time to hours instead of weeks.

With configurable actions that allow you to capture processes in end-to-end workflows, Agatha Clinical provides a tool to enforce best practices, document all activities, and connect all study participants. The result is faster start-up, more consistent processes, and complete trial documentation ready for inspection at any time.




Your Trial Master File is
up-to-date at all times and ready for sponsors, CROs, sites and, most importantly, auditors and inspectors.

Complete, Connected


Document creation, review and approvals are fully automated to ensure efficient and effective execution of all trial activities.



Every authorized trial participant
— sponsors, CROs, and site — can connect to the cloud-based TMF without the need for cumbersome IT processes.



Agatha Clinical is built around the industry-standard eTMF reference model and ensures that every document expected in the file is present.

Efforts to streamline medical product development based on advancing science can be frustrated by legacy business models that discourage collaboration and data sharing, and the adoption of disruptive technologies that make clinical research more effective.
Former FDA Commissioner Scott Gottlieb

Talking about the need to leverage new technologies to accelerate clinical trials.

Agatha Clinical Features

New Sites

Build new trial sites instantly, based on
the TMF Reference Model.

Documents & Forms

Combine documents and forms to accelerate study processes.

inspect & Verify

Inspect, verify and identify gaps in
expected eTMF contact at any time.

One location

Ensure availability of all trial
documents, in one location, with baked
in quality review processes.

Review & Approval

Automate creation, review and
approval tasks with configurable

Permissions & Access

Accessible by all authorized trial
participants — sponsors, CROs and site owners.

Agatha Applications

Clinical eTMF
Remote Monitoring
SOP application
Quality Management Application
Regulatory Application

The best way to know if Agatha Applications are right for you is to try them.

Fill out the form and select the application you would like to try for free for 21 days.


Not sure if you are ready for a trial? Learn more about our trial period to know if it's right for you.

And if you still aren't ready - we'd love to show you a demo.

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