Blogs

The management of clinical trial documentation is a crucial aspect of running efficient and compliant clinical trials. With rising costs and complexity of trials, having an electronic trial master file (eTMF) system has become pivotal. In this blog, we will understand what an eTMF is, its components, benefits, challenges, and

The Trial Master File for clinical research (TMF) is the centralized collection of essential documents that provide evidence of compliance with standards of Good Clinical Practice (GCP) for a clinical trial. A properly maintained TMF tells the complete story of a trial from conception to completion. As sponsors and research

Saving people in clinical investigations is key. The Food and Drug Administration (FDA) follows strict laws, making sure vital steps are taken. This includes thorough tracking, recording, and holding essential info for the trial’s management. This post tackles the ins and outs of FDA rules. It talks about how important