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.
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
Agatha Clinical
Inspection-ready Management of Essential TMF Documents and Records
Agatha SOP
Creation, Review and Approval of SOPs and Employee Training Records
Agatha Quality
Quality Document and Process Management for CAPAs, Deviations, & Change Control
Agatha Regulatory
Easily manage your regulatory documentation following the EDM Reference Model.
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.
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Agatha offers a fully supported free pilot where you can test our applications using your real information and processes.
Just fill in the 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.