CONNECT. COLLABORATE. CONTROL.   

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.

Benefits

Inspection

Ready

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

Processes

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

Connects

Everyone

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

Fully

Compliant

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
workflows.

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

Ready to learn more about Agatha's Applications? Maybe it's time to think about a trial.

But not just any trial - an Agatha trial.

===

Agatha offers a fully supported free pilot where you can test our applications using your real information and processes.

Just fill in the form arrow pointing to a form
and we’ll get right back to you to get you set up.

If you're not sure, you can learn more about our Pilot process here. If you’re not quite ready to sign up for the pilot, request a demo instead.

Copy link
Powered by Social Snap