12.13.25 -- Best Of November

As the FDA, MHRA, and EMA release draft frameworks on externally controlled trials, sponsors face differing expectations. The U.K. leans pragmatic, the U.S. remains cautious, and Europe’s guidance is still evolving — leaving global trial planners to navigate regulatory gray zones.

AI is evolving the TMF into a proactive intelligence engine. Learn how machine learning and generative tools automate compliance, enabling continuous quality oversight and risk-based decision-making.

Former FDA Commissioner Scott Gottlieb warns that a leaner, under-resourced FDA will make life harder for clinical operations, while former FDA Commissioner Robert Califf argues the deeper failure lies in a healthcare system that’s forgotten how to learn from itself. Together, they paint a sobering picture of what’s really broken in clinical research — and why fixing it will take more than new guidance.

Outdated budgeting slows oncology trials. Real-world site cost data enables faster planning, smoother startup, and better patient care through smarter, evidence-based financial decisions.

Through careful planning, aligned incentives, and an open, adaptive mindset, master protocols become powerful engines for accelerating therapies to market—particularly in high-need therapeutic areas.

Learn how implementing controlled, automated systems can minimize contamination risk and ensure the reliable data consistency needed for scalable discovery and reproducible results.