Collaborate and Digitally Streamline Trial Master File Documentation Across Studies and Sites using Compier eTMF
With increasing concerns on patient safety, Regulatory agencies expect sponsors to have clinical sites audit-ready with an accurate Trial Master File (TMF) to account for all trial activities and provide complete visibility on the trial conduct progress with complete documentation. Regulators such as the European Medicines Agency and Medicines & Healthcare Products Regulatory Agency (MHRA) expect, at a minimum, that an organization’s TMF accurately reconstructs how a clinical trial was conducted to demonstrate effective sponsor oversight, support decisions made, and comply with GCP guidelines.
