eTMF

Agatha eTMF provides an inspection-ready platform for managing essential Trial Master File (TMF) documents and records. It enables the creation and management of sites and clinical trial content, eliminating the need for paper documents by allowing users to create and manage new TMF files based on the TMF Reference Model. This system combines documents and forms to streamline study processes.

The dashboard offers access to workspaces and tasks, allowing users to view all clinical trials and quickly access assigned tasks. Configurable views help inspect, verify, and identify gaps in the expected eTMF content at any time.

Users can author and edit Microsoft Word, Excel, and PowerPoint files directly within the electronic TMF, without needing Microsoft Office. The platform also supports quality checks by designating documents for review and tracking the quality review process through custom views.

Benefits of Agatha eTMF

• Easy remote collaboration and data collection: Enhance TMF network performance, share insights, and prevent duplicate information uploads. The eTMF supports collaboration throughout the TMF management lifecycle, from setup to archival, with documents uploadable by trusted users from any location.
• Secure online data storage: Transition to a paperless office with electronic files stored securely. The eTMF ensures secure and reliable file storage with password protection, providing easy data access to research teams.
• Track progress easily: Real-time tracking systems provide pertinent information when needed, reducing organizational burdens and facilitating real-time document management.
• Compliance with 21 CFR part 11: The eTMF includes systems and controls for compliance, such as audit trails, user account controls, archival policies, and electronic signatures, supported by process-driven workflows for data collection, storage, sharing, and synchronization.