As the curtain closed on 2024, FDA issued a new draft guidance to assist clinical trial sponsors, investigators, and institutional review boards (“IRBs”) with defining, identifying, and reporting ...

Yale New Haven Children’s Hospital developed a testing protocol with specific clinical indications for testing and clear informed consent expectations.

The integration of real-world data (RWD) into protocol feasibility and site selection has emerged as a clinical trial game-changer in recent years. Traditionally relying heavily on data from carefully ...

When discussing the future of clinical trials, people often focus on the promise of exciting new technologies, including artificial intelligence (AI) and predictive modeling. However, even the most ...