Month: August 2024

4 Reasons Why GCP Compliance Is Important

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials. It serves to protect the rights, integrity, and confidentiality of trial subjects. Ensuring compliance with GCP principles is crucial in clinical trials. This article will highlight four key reasons […]

Top TMF Metrics Every Clinical Trial Should Monitor

To effectively manage the Trial Master File (TMF), it is essential to track and monitor key metrics or Key Performance Indicators (KPIs) that measure the completeness, timeliness, accuracy, accessibility, and compliance of the TMF with regulatory guidelines. Monitoring these metrics ensures the TMF is always inspection-ready, facilitating smooth regulatory reviews and demonstrating thorough oversight of […]