The Society for Clinical Data Management (SCDM) annual conference has always been a cornerstone for clinical data professionals, but this year’s event, held in Boston from September 30th to October 2nd, felt like a turning point for the industry. Clinical data management is on the cusp of a technological revolution, and at the heart of […]
Welcome to this month’s Quality Issue, where we spotlight some of the most important developments in clinical research and Risk-Based Quality Management (RBQM). From transformative FDA guidance to our upcoming virtual event, here’s what you need to know. FDA Draft Guidance Aims to Transform Clinical Trials by Integrating RCTs into Routine Practice The FDA has […]
The FDA has just released a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products Into Routine Clinical Practice Guidance for Industry” aimed at transforming how Randomized Controlled Trials (RCTs) for drug and biological products are conducted. If finalized, this move could reshape the clinical trial landscape by merging trials with routine healthcare […]
The U.S. Food and Drug Administration (FDA) has made a significant move to modernize clinical research with the release of its final Guidance for Conducting Clinical Trials with Decentralized Elements. Published this month, the guidance reflects the increasing adoption of decentralized clinical trials (DCTs), where activities like telehealth consultations, home-based care, and the involvement of […]
