CONNECT. COLLABORATE. CONTROL.
Agatha Clinical (eTMF)
Connect sponsors, CRO staff, and site resources with automated processes for creating, managing, and tracking the Trial Master File (TMF).
Agatha’s eTMF Can Help
Agatha Clinical is an electronic master file (eTMF) application that connects all trial participants and processes in a single, cloud-based application.
Leveraging the TMF Reference Model, Agatha Clinical includes standard templates to help you get up and running quickly, reducing ramp-up time to hours and days instead of weeks or months.
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.
With Agatha Clinical (eTMF) you are…
Your Trial Master File is
up-to-date at all times and ready for sponsors, CROs, sites and, most importantly, auditors and inspectors.
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 eTMF 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.
“The decision to move to an electronic TMF and move its management in-house was the right decision for us. With Agatha’s help, we were able to configure an eTMF application that supports our needs today and can adapt with us as our processes evolve.”
How Agatha’s eTMF Supports Your Clinical Trials
Create and Manage Sites & Documents
Create and manage trial sites based on the TMF Framework. Combine documents and forms to accelerate study processes.
Access Workspaces and Tasks in the Dashboard
View all your workspaces for each clinical trial site in the dashboard and quickly see and access tasks assigned to you. Use the configurable views to inspect, verify, and identify gaps in the expected eTMF contract at any time.
Author and Edit Documents Directly in the App
Co-Author and edit Microsoft Word, Excel, and PowerPoint files directly in the application, without the need for a Microsoft Office license.
Ensure Quality Checks Are Completed
Designate documents for the quality check process and track the quality review using custom views.
You Get More With Agatha Clinical (eTMF)
Custom Forms and Rendering
Leverage forms to drive processes based on metadata and use metadata to generate renditions.
Basic Preview and Annotations
Cross Workspace Reporting
Create views and reports across workspaces and export results to Excel for dashboard reports.
Extended Template Sets
Collect feedback from sites with Post Market Surveys and collect consent documents with Informed Consent.
Advanced Policy and Access Management
Advanced Integration Toolkit
Use Agatha’s Rest API to allow applications to upload or export items from Agatha (includes documentation & sample code).
Get the Edition of Agatha Clinical (eTMF) That Works for You
- Pre-validated functionality for core ClinOps processes
- Check-in, Check-out, and Version Control
- Electronic Signatures and Complete Audit Trails
- Flexible review and approval workflows
- Full compliance with 21 CFR Part 11 and related Regulations
- All Standard Features, Plus
- Advanced reporting with Metrics and Dashboards
- Live Co-annotation for simultaneous review of documents
- Custom forms capability
- Advanced, role-based access management
- Everything in Extended
- "In Application" Microsoft Word and Excel editing – No Word required
- Live collaborative authoring and editing
- Extended template sets for SOPs, Informed Consent, and more
- Integration toolkit with Rest API support
The best way to know if an Agatha Application meets your needs is to try it out. And good news - we offer a free trial.
Complete the form, select the application you would like to try and we'll reach out to get you set up as quickly as possible.
Want a little more information on your trial process? Go here.