The pilot pairs drug sponsors with qualified research institutions to compress the path from drug identification to first-in-human study through rolling submission review and earlier coordination of institutional review board and site activation activities.

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 how ICH E6(R3) and new empirical evidence of RBQM's net financial impact give sponsors the tools they need to build the multi-functional buy-in required for successful adoption—and why RBQM only delivers full value when it replaces, not supplements, traditional monitoring.

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.

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.

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 what genuine patient voice requires beyond buzzwords, why AI's next bottleneck is system integration not models, and how regulators across three jurisdictions are formalizing patient input requirements.