Andy Studna, Senior Editor

In this video interview from the 2026 DIA Global Annual Meeting, Angie Maurer, VP of AI-enabled clinical development at Medable, explains the three structural barriers that kept protocol digitization out of reach and why the convergence of LLMs, industry standards, and validated environments has finally changed the equation.

In this video interview from the 2026 DIA Global Annual Meeting, Kevin Bugin, head of global regulatory policy and intelligence at Amgen and executive sponsor of TransCelerate's Embedded Pragmatic Trials initiative, reframes the FDA's continuous review expectations around real-time evidence generation and explains why quality by design—not data cleanup—is what regulators are now demanding.

In today's ACT Brief, we examine building infrastructure for real-time clinical and real-world data integration, modernizing participant payments to reduce dropout, and a Phase III confirmatory trial failure for a lung cancer drug.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, explains why organizations that build infrastructure capable of harmonizing clinical and real-world data in real time will be best positioned for the continuous, data-driven regulatory environment now emerging.

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 this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, describes how giving sponsors the ability to inject their own SOPs, protocols, and governance frameworks into AI systems is the key to building the trust needed for real-world adoption.

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 this Q&A, Abraham Gutman, founder and CEO of AG Mednet, discusses why the clinical trial industry has mastered data capture but never built the execution architecture needed to act on it, how the right infrastructure changes the role of human experts, and why enthusiasm for agentic AI is outrunning what clinical trials can realistically support.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, argues that study-by-study RBM is no longer sufficient and describes what enterprise-wide, AI-enabled risk and quality management looks like in practice.

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 this Q&A, Robert Hummel, chief operating officer at Suvoda, discusses how agentic AI is compressing RTSM build and deployment timelines, what safeguards are needed to maintain compliance and oversight at speed, and how intelligent automation will reshape the broader clinical trial technology stack over the next decade.

In this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, makes the case that governance and quality must be built into every stage of the trial life cycle—not enforced at database lock or submission—and what that requires from teams and technology.

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 this video interview, Raj Indupuri, CEO and co-founder of eClinical Solutions, explains why the FDA's push toward continuous data review exposes the fragmentation at the heart of current clinical trial infrastructure and what unified data pipelines need to look like to make it possible.

From rising costs and regulatory uncertainty to persistent vaccine hesitancy, sponsors face mounting pressure to standardize operations, build community trust, and develop the behavioral capabilities needed to run vaccine trials effectively in a rapidly shifting environment.

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 this video interview, Liz Beatty, co-founder and chief strategy officer at Inato, makes the case for moving beyond trial-by-trial planning toward cross-asset site partnerships—and explains why sites are three times more likely to share patient data when sponsors make that shift.

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 this video interview, Liz Beatty, co-founder and chief strategy officer at Inato, explains why asking sites to use different technology for every sponsor remains a major barrier to AI adoption and what a site-first approach to technology development looks like in practice.

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.

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.

In this video interview, Abraham Gutman, founder and CEO of AG Mednet, shares his key takeaways from SCOPE X, including a pointed caution against the idea that agentic AI can run clinical trials autonomously and why process architecture is the real entry point for AI to deliver on its promise.

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.