What is eTMF?

An electronic Trial Master File (eTMF) is a structured collection of documents and other essential records that demonstrate the conduct of a clinical trial. It serves as a central repository for all trial-related information, ensuring compliance with regulatory requirements (e.g., FDA, EMA) and providing a complete and accurate account of the trial's activities. eTMF systems are commonly used by pharmaceutical companies, biotechnology firms, and contract research organizations (CROs) to manage and maintain their clinical trial documentation electronically, improving efficiency, transparency, and audit readiness.