eTMF

Agatha eTMF is an electronic Trial Master File solution designed to support inspection-ready management of essential TMF documents and records throughout the full life cycle of clinical trials. Built for study teams, clinical operations professionals, and regulatory affairs personnel, it replaces paper-based processes with a structured, compliant, and collaborative digital environment aligned to the TMF Reference Model.

The platform enables organisations to create, manage, author, and track TMF content from initial study setup through to archival, providing real-time visibility into trial documentation status and ensuring readiness for regulatory inspection at any point in the trial lifecycle.

Core Features

• Site and Clinical Trial Content Management: Create and manage new TMF files based on the TMF Reference Model, combining documents and forms to accelerate study processes and eliminate reliance on paper documents.
• Dashboard Workspaces and Task Management: View all clinical trials from a central dashboard, quickly access tasks assigned to individual users, and use configurable views to inspect, verify, and identify gaps in expected eTMF content at any time.
• In-Application Document Authoring and Editing: Co-author and edit Microsoft Word, Excel, and PowerPoint files directly within the application, removing the need for a separate Microsoft Office installation.
• Quality Check Tracking: Designate documents for quality checks and monitor the quality review process using custom views, ensuring that all required quality controls are completed and documented.

Key Benefits

• Remote Collaboration and Data Collection: Agatha eTMF increases the performance of TMF networks by enabling the study team to collaborate across the full TMF management lifecycle. Documents can be uploaded by trusted users from any location, and desktop-based documents stored at the project home site can be automatically uploaded via an Integrated Data Services file, reducing duplication and accelerating data interactions.
• Secure Online Data Storage: The platform supports paperless offices by replacing hard copies with electronic files stored within a complete, electronic TMF. Files are stored securely with password protection, providing controlled access to different research teams while maintaining data integrity.
• Real-Time Progress Tracking: An integrated, real-time tracking system delivers pertinent information to users wherever and whenever it is needed, reducing the organisational burden of coordinating clinical trial documentation and minimising barriers to adoption.
• 21 CFR Part 11 Compliance: Agatha eTMF provides the systems and controls required for regulatory compliance, including audit trails, user account controls, archival policies, and electronic signatures. It employs process-driven workflows to collect, store, share, and synchronise data in accordance with regulatory requirements.

Agatha eTMF is suitable for organisations seeking a fully compliant, collaborative, and scalable eTMF solution. The platform supports demos and direct inquiries for teams evaluating clinical trial document management software.