Current Edition

Electronic Trial Master File: Gaining Efficiency for Oversight and Control

Maintaining an electronic Trial Master File (eTMF) is far more than storing study documents on the sponsor’s file server. EMA’s reflection paper on Trial Master Files provides guidance in identifying requirements and expectations. They can only be met by mastering important challenges, but an eTMF introduces a new level of efficiency in TMF handling. Andreas Grund of GCP-Service International Ltd and Jörg Mielebacher, Founder and CEO of PCQ Pilots discusses, the obvious gain in efficiency by automated TMF reporting tools makes an electronic TMF a valuable option for large, medium and small organizations.