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Senior FDA leaders outline concrete steps to strengthen inspection coverage and data integrity review as the globalization of clinical research strains the agency's oversight capacity.

In this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD explain why time savings dominates the eNPV model for RBQM—and what that means for how sponsors should frame the internal case for investment.

In today's ACT Brief, we examine why many trial failures trace to human readiness gaps rather than process design alone, how CRO consolidation expands early-phase capacity, and how AI-enabled patient matching is reshaping recruitment economics.

As sponsors push for faster, more representative studies, AI-enabled matching and EHR integration are emerging as operational levers, but bias, explainability, and governance will determine whether the technology scales.

The all-cash transaction adds a good laboratory practice-compliant bioanalytical laboratory, a 200-bed clinical pharmacology unit, and a biospecimen storage facility to Fortrea's early-phase development network.

This pilot episode of The Human Side of Clinical Trials introduces a framework from Brian S. McGowan, PhD, FACEHP, chief learning officer and co-founder of ArcheMedX, Inc., exploring why operational failures in clinical trials often trace back to gaps in human readiness rather than process design alone.

In today's ACT Brief, we examine how eNPV modeling and real-world data finally put numbers on RBQM value, why static budgeting masks true site costs, and GSK advancing an mRNA flu vaccine candidate to late-stage testing.

In this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD explain how combining real-world deployment data with eNPV modeling finally made it possible to put a number on the financial value of RBQM—and why oncology was chosen as a conservative starting point.

Static budgeting models and one-size-fits-all fair market value approaches create visibility gaps around inflation and true site costs, but regional frameworks, standardized costing toolkits, and accountability metrics can rebuild trust and replace defensive negotiations with transparency.

Agentic AI is arriving in clinical operations with genuine capability to absorb administrative work, but the organizations that will realize lasting value are those willing to redesign accountability structures, financial workflows, and operating models before deploying the tools on top of them.

AI platforms that absorb trial data reconciliation could compress operations toward a small, accountable team.

In today's ACT Brief, we examine why 80% of sites operate on minimal cash reserves, how biomarker-informed enrollment risks excluding viable patient populations, and the growing role of predictive maintenance in preventing batch losses.

Biomarker-informed trial enrollment appears straightforward for identifying responders and optimizing efficiency, but failures to account for demographic variation in cut-off selection, causality versus correlation, and composite biomarker complexity risk excluding viable patients and exacerbating disparities.