ACT Brief: Clinical Workflow User Experience, Sample Integrity and Logistics, and FDA's Unified Adverse Event System

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In part two of her video interview, Cheryl Kole, vice president of solution strategy and commercialization at Almac Clinical Technologies, examined why current eClinical technology often prioritizes data infrastructure over the day-to-day needs of busy site teams. A truly guided workflow experience should simplify execution rather than obscure it behind fragmented systems.
• In a new contributed article, Charles Castano, chief technology officer at LabConnect, addressed the last mile dilemma where precision medicine meets outdated logistics. By integrating digital capture at point of care, real-time logistics adjustments, and consistent data formatting across labs, organizations can prevent sample degradation and reduce the manual workload that consumes scientific capacity on repetitive protocol management tasks.
• On March 11, the FDA launched the Adverse Event Monitoring System consolidating seven separate databases into a single platform for drugs, biologics, vaccines, and cosmetics. The shift to real-time publication replaces quarterly releases, reducing lag between safety signal emergence and visibility to manufacturers and researchers. However, the simultaneous FDA letter to Novo Nordisk regarding unreported semaglutide deaths underscores that infrastructure improvements alone cannot replace manufacturer reporting compliance and timeliness.

That's all for today's ACT Brief. Join us next week for more updates shaping clinical operations and drug development. Thanks for listening.