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In today's ACT Brief, we examine the data collection-to-analysis gap undermining continuous trial monitoring, why AI agents require foundational workflow infrastructure, and FDA approval of a novel ADHD treatment.

AI agents operate only within workflows, but most organizations lack unified workflow management systems, making it difficult to identify where agents should be deployed or ensure they integrate effectively across connected business processes in clinical research.

In this video interview, Raviv Pryluk, CEO and co-founder of PhaseV, explains why the gap between data collection and analysis-ready data undermines the promise of continuous trial monitoring and what it will take to close it.

In today's ACT Brief, we examine how inspection readiness must accumulate rather than assemble, why AI initiatives stall without disciplined governance, and what US clinical trials need beyond isolated initiatives.

In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, describes what it means to accumulate inspection readiness rather than assemble it—and why the story regulators reconstruct is determined long before an inspection is announced.

AI churn—repeatedly restarting initiatives before scaling them—stems from organizational execution gaps rather than technology limitations, but agentic AI amplifies these gaps by requiring connected systems, trustworthy data, and disciplined governance from the start.

In today's ACT Brief, we examine why execution failures originate upstream despite surfacing downstream, how European health data frameworks transform CRO roles, and why US trial competitiveness varies by development phase.

The European Health Data Space reshapes CRO operations by transitioning them from data custodians to regulated users accessing data within secure, auditable environments, enabling cross-border research but requiring substantial investment in compliance, standardization, and methodological rigor.

In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, explains why execution failures surface where they're visible but originate where conditions were set—and why clinical operations leaders too often inherit problems they had no hand in creating.

Bayer and Henry Ford Health announce a strategic research alliance, while Massive Bio and FOMAT launch an AI-driven oncology prescreening pilot—both targeting barriers that keep eligible patients from reaching clinical trials.

In this video interview, Elizabeth Walsh, founder of Walsh Clinical Advisory and co-author of The Clinical Execution Blueprint, identifies where the most consequential capability gaps accumulate—from protocol-to-execution bridging to how sponsor oversight roles are structured and staffed.

In today's ACT Brief, we examine how early assumptions govern development outcomes, why single pivotal trials require portfolio recruitment with integrated technology, and how risk frameworks must embed quality into design from the start.

In this Q&A, Gaynor Anders, chief delivery officer at Trialbee, discusses how the FDA's single pivotal trial shift is raising the stakes on patient recruitment, why the study-by-study model has persisted for so long, and what program-level recruitment actually requires from sponsors in terms of infrastructure, data sharing, and organizational change.