Andy Studna

New collaborations with Causaly, Databricks, and Microsoft anchor a broader push to embed artificial intelligence directly into clinical trial decision-making and operational workflows.

In today's ACT Brief, we examine why AI architecture and ownership matter more than model sophistication in clinical development, how the FDA proposes to regulate generative AI-enabled medical devices, and a new leadership appointment at the agency

In this video interview, Patrick Mizer, chief technology officer at Ledger Run, traces the fragmented contracts, outdated benchmarks, and disconnected systems behind payment inconsistency—and explains why the industry has historically accepted the complexity rather than addressed it.

Agentic AI is arriving in clinical operations with genuine capability to absorb administrative work, but the organizations that will realize lasting value are those willing to redesign accountability structures, financial workflows, and operating models before deploying the tools on top of them.

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.

In today's ACT Brief, we examine why black-box AI fails in clinical trials, how participant understanding drives engagement more than gamification, and FDA permanent leadership appointments prioritizing regulatory predictability.

In this video interview, Amélie Lothe, global medical community head for rare epilepsies at UCB Pharma, explains why genuine patient partnership begins before the protocol is written—and what it looks like when patients and caregivers tell you a trial was designed with them in mind.

In this Q&A, Patrick Mizer, chief technology officer at Ledger Run, discusses how payment reliability has become a competitive differentiator in site selection, why decades of disconnected workflows have made payment inconsistency a structural problem, and where AI is delivering real value in the high-friction parts of clinical trial payments.

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.

In this Q&A, John Worden, chief commercial officer at Javara, discusses why clinical trial recruitment has remained stubbornly one-size-fits-all, how AI can identify patients at scale without displacing the clinician relationships that drive trust, and what care-integrated research engagement needs to look like for health systems, sponsors, and sites.