ACT Brief: Enterprise Risk Management, Execution Architecture for AI, and Rare Pediatric Regulatory Support

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

• In part three of his interview, Raj Indupuri of eClinical Solutions, argued that study-by-study RBM is no longer sufficient and described what enterprise-wide, AI-enabled risk and quality management looks like in practice. Moving from siloed, reactive monitoring to integrated, predictive governance across a portfolio enables better resource allocation and faster signal detection.
• In a new Q&A, Abraham Gutman, founder and CEO of AG Mednet, discussed why the clinical trial industry has mastered data capture but never built the execution architecture needed to orchestrate decisions and handoffs across teams. Using an orchestra metaphor, Gutman emphasized that AI capabilities operating without infrastructure are "tetherless in space"—useful technology disconnected from where decisions actually happen. Infrastructure and process management are the entry point for AI to deliver on its promise.
• In a Pharmaceutical Executive interview, Lisa Bollinger, chief medical officer at Polaryx, discussed the robust regulatory landscape for rare pediatric diseases, with FDA and EMA establishing dedicated rare disease divisions and offices to support development. Recent guidances and infrastructure investments signal agency commitment to enabling trials and accelerating therapies for underserved patient populations.

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