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In today's ACT Brief, we examine value hidden in the RBQM financial model, why rare disease research leads on genuine patient partnership, and how safety concerns shape IBD treatment decisions despite clinical efficacy.

Patient-centricity remains largely consultative in most clinical research, yet rare disease communities demonstrate that genuine partnership from protocol inception improves feasibility, reduces unnecessary burden, and identifies outcomes that matter to patients themselves.

In this video interview, Sylviane de Viron of CluePoints and Abigail Dirks of Tufts CSDD discuss what the RBQM financial model left out—reduced rework, improved data integrity, and inspection readiness—and why those excluded factors could represent even greater value than what was modeled.

In today's ACT Brief, we examine why time savings dominates the financial case for RBQM investment, how the FDA is strengthening inspection access and data integrity review, and how data governance models shape real-world evidence quality.

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.

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.

In today's ACT Brief, we examine why operating model redesign must precede agentic AI deployment, how integrated platforms compress operations toward accountable teams, and BioNTech's decision to terminate a colorectal cancer mRNA trial.