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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 this Q&A, Sam Hinsley, statistics manager at Phastar, discusses the role statisticians play in raising standards across the clinical development timeline—and why getting early phase decisions right is critical to the entire drug development pathway.

In this video interview, Liz Beatty, co-founder and chief strategy officer at Inato, shares results from a Sanofi COPD study where AI-enabled sites screened patients 33% faster and achieved 100% enrollment success—including one site that had been non-performing for over 100 days.

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 this video interview, Liz Beatty, co-founder and chief strategy officer at Inato, explains how AI is replacing unreliable feasibility estimates with precise, real-time patient matching—and what that means for reducing non-enrolling sites and screen failure rates.

Optimization challenges spurring cultural, strategic, and organizational change.

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.

As the FDA formally recognizes real-world evidence as eligible confirmatory evidence for drug approval, sponsors face a growing imperative to build the data infrastructure, organizational alignment, and analytical capabilities needed to use RWE effectively across the development lifecycle.

Real-world evidence is shifting from a post-market footnote to a concurrent validation layer running alongside trial data, requiring organizations to build unified data environments that integrate EHRs, claims, and patient-reported outcomes on an ongoing basis rather than retrospectively.

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 this Q&A, Del Smith, PhD, CEO and co-founder of Acclinate, discusses how structural and relational barriers continue to limit participation from underrepresented communities in clinical trials—and what it takes to build the kind of trust that translates into lasting research impact.

In this video interview, Abraham Gutman, founder and CEO of AG Mednet, describes how AI can take on rote reasoning tasks like PHI redaction and document QA, and why offloading that work is what gives human experts the clarity to focus on genuine decision making.

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.