ACT Brief: RBQM and AI Integration, Statistician Role in Data Stewardship, and Oncology Regulatory Navigation

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

• In a new contributed article, Ken McFarlane of CluePoints outlined how operational RBQM requires cross-functional alignment, proper process assessment, and AI-enhanced data management to replace legacy monitoring with targeted, risk-based approaches. Intelligent query detection, medical coding accuracy up to 99%, and consolidated medical review platforms enable earlier issue detection and audit-ready compliance aligned with ICH E6(R3) and E8(R1).
• In part two of her video interview, Sam Hinsley, statistics manager at Phastar, explained how statisticians can ensure patient data is used responsibly and innovatively across rare disease, personalized medicine, and AI applications throughout development.
• In a new interview from Pharmaceutical Executive, Harpreet Singh, MD, chief medical officer at Precision for Medicine and former FDA Oncology Division Director, emphasized that navigating FDA regulation is "much more facile" with inside knowledge. Singh stresses early and frequent agency engagement, tracking regulatory precedent, and understanding individual division nuances, noting the FDA is data-driven but "not a monolith."

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