The paper addresses the need to modernize regulatory frameworks for clinical trials, emphasizing that inefficiencies stem from outdated concepts rather than regulatory intent. It proposes eliminating the term ‘source,’ recognizing Trusted Third Parties, and embracing digital standards like certified copies. Additionally, it recommends a new ‘HyperTrial’ designation for technologically advanced studies and supports adaptive statistical decision-making in trials. These changes aim to enhance trial quality, reduce costs, and align regulations with current technological advancements, ensuring timely and efficient clinical research.

A recent note-to-file podcast from Brad Hightower with Bree Burks from Veeva discussed why EDC systems have been designed and developed for the benefits of the Sponsor over and above the Site? I would like to discuss a few reasons. …

The clinical research organization (CRO) sector faces significant challenges, with a high failure rate primarily due to costs, inefficiencies, and outdated practices. Although there is potential for transformative models to emerge, establishing credibility and navigating complex regulatory landscapes necessitates time and expertise. Successful innovation in this field requires a blend of creativity and domain-specific knowledge.