In today's ACT Brief, we examine practical guidance for clinical operations teams beginning AI adoption, how hierarchical endpoints better reflect treatment benefit, and why early-stage program failures signal smarter pipeline management.
News|Podcasts|March 30, 2026
ACT Brief: Clinical Workflow User Experience, Sample Integrity and Logistics, and FDA's Unified Adverse Event System
Author(s)Andy Studna, Senior Editor
In today's ACT Brief, we examine why eClinical platforms must prioritize user workflows over data flow, how digitizing sample tracking prevents integrity failures in transit, and the FDA's consolidated adverse event monitoring system enabling real-time safety signal detection.
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Charles Castano, chief technology officer at LabConnect, addressed the last mile dilemma where precision medicine meets outdated logistics.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.
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