In today's ACT Brief, we examine AI-enabled systems medicine connecting fragmented clinical data, how behavioral readiness and trust drive enrollment more than eligibility criteria, and scaling concentrated AI strategy across a global pharmaceutical enterprise.
In today's ACT Brief, we examine how selective safety data collection could ease operational burden and address investigator shortages, why site-specific technology limits AI adoption, and how regulatory pressure and patent cliffs are reshaping R&D investment strategy.
In today's ACT Brief, we examine regulatory partnerships debunking pragmatic trial concerns, how ePRO protocols create informal patient exclusions, and why system design—not patient behavior—drives disengagement.
In today's ACT Brief, we examine quantified reductions in trial visits through selective safety data collection, why protocol failures occur during operational transition, and congressional investigation into pharmaceutical company trials in China.
In today's ACT Brief, we examine a major trial retraction and regulatory action against a rare disease drug, regulatory scenarios for selective safety data collection, and FDA's domestic manufacturing incentive program.
In today's ACT Brief, we examine what the FDA's real-time oversight initiative demands of sponsors, why clinical data security must be designed in rather than layered on, and how AI is reshaping CDMO workflows and asset value.
In today's ACT Brief, we recap key themes from DIA 2026 on operational priorities and regulatory shifts, examine infrastructure gaps in continuous data review, and report on EMA support for a new BTK inhibitor strategy.
In today's ACT Brief, we examine integrating site and sponsor data systems, a high-profile trial retraction over integrity concerns, and a new first-line breast cancer treatment.
In today's ACT Brief, we examine regulatory uncertainty and 2026 breakthroughs shaping clinical research, reimagining CRO contracting models for financial transparency, and Eli Lilly's acquisition strategy.
In today's ACT Brief, we examine HHS coordinated effort to restore US clinical research leadership, two decades of rising protocol complexity, and data architecture frameworks for AI sustainability.
In today's ACT Brief, we examine a major CRO-tech partnership scaling agentic AI, operational challenges sites face with decentralized trials, and AI-driven CNS drug discovery collaboration.
In today's ACT Brief, we examine mixed FSP models as strategic agility tools, key themes from the 2026 DIA Global Annual Meeting, and federated AI expanding oncology research.
In today's ACT Brief, we examine real-time evidence generation priorities, automating protocol digitization, and fit-for-purpose decentralized trial deployment.
In today's ACT Brief, we examine quantified returns on RBQM implementation, why allowing sponsors to control AI governance builds adoption, and how basket trials reshape rare pediatric oncology development.
In today's ACT Brief, we examine moving beyond study-level risk management, why execution architecture is essential before AI can deliver value, and growing FDA/EMA support for rare pediatric disease development.
In today's ACT Brief, we examine building governance into every trial stage, how agentic AI is compressing RTSM startup timelines, and why state medical access programs could strengthen rather than undermine clinical trials.
In today's ACT Brief, we examine how FDA continuous data review exposes trial infrastructure gaps, vaccine trial standardization amid regulatory uncertainty, and a major collaboration on a BTK degrader for blood cancers.
In today's ACT Brief, we examine how cross-asset site partnerships drive data sharing, standardized eCOA templates accelerating vaccine trial startup, and real-world data revealing ovarian cancer disparities.
In today's ACT Brief, we examine why site technology fragmentation blocks AI adoption, how agentic orchestrators and lakehouse architectures enable real-time clinical data harmonization, and evidence-based strategies to reduce obesity trial discontinuation.
In today's ACT Brief, we examine AI-enabled site performance in a Sanofi COPD study, why statisticians raising early phase standards matters to the entire development pathway, and a new partnership on RNA exon editing for monogenic kidney disease.
In today's ACT Brief, we examine AI replacing unreliable feasibility estimates with precise patient matching, three tensions reshaping clinical operations culture, and FDA's first oral post-exposure COVID-19 prevention therapy.
In today's ACT Brief, we examine why process architecture matters more than autonomous agentic AI, shifting RWE from post-approval to concurrent validation, and organizational capabilities needed for effective RWE use.
In today's ACT Brief, we examine how AI handles rote tasks to free human experts for critical decisions, what authentic community engagement requires beyond recruitment, and recent lupus treatment advances shifting standard of care.
In today's ACT Brief, we examine why decades of data capture progress haven't solved trial execution, study coordinator performance on document reviews, and FDA advisors voting on updated COVID-19 vaccine composition.
In today's ACT Brief, we examine why paper-based outcome assessments persist despite clear data-quality disadvantages, why early phase statistical decisions shape entire development pathways, and the structural changes needed for representative enrollment.
In today's ACT Brief, we examine how Merck embeds diversity into trial execution from design through community engagement, a new statistician special interest group for early phase research, and FDA's first approval for chronic hepatitis delta virus.
In today's ACT Brief, we examine what succeeding under compressed FDA review timelines requires, why statistician collaboration is essential as trial complexity grows, and GLP-1s reshaping pharma portfolio strategy.
In today's ACT Brief, we examine operational RBQM enhanced by AI, how statisticians ensure responsible data use across development phases, and navigating oncology regulation after FDA leadership transitions.
In today's ACT Brief, we examine how program-level orchestration is becoming critical to R&D success, reflections on meaningful work in clinical trials, and industry concerns about FDA communication and institutional knowledge loss.
In today's ACT Brief, we examine safety signal prioritization in RBQM, widening performance gaps between early AI adopters and the broader industry, and data quality concerns in FDA's real-time clinical data review initiative.
