Regulatory Affairs Editorial

31. Contracting For AI In Clinical Trials: Cybersecurity, Monitoring, And Risk Allocation (Part 3) 5/15/2026

    Leibowitz Law shares the third installment of its three-part series on contracting for AI in clinical trial operations. Part 3 picks up with cybersecurity, monitoring and validation, and risk allocation.

32. Contracting For AI In Clinical Trials: Data Rights And Regulatory Compliance (Part 2) 5/15/2026

    Leibowitz Law's three-part series examines how AI is being used in clinical trial operations and the contractual and operational risks that follow. Part 2 demonstrates why organizations must understand where it is used, how it interacts with data, and where the risks lie.

33. Where AI Appears In Clinical Trials — And Why Contracts Need To Catch Up (Part 1) 5/15/2026

    Leibowitz Law's three-part series examines how AI is being used in clinical trial operations and the contractual and operational risks that follow. Part 1 outlines where AI appears in ClinOps and supporting technologies, and the questions companies and organizations should ask when AI touches data.

34. The U.S. Clinical Trial Recruiting Pipeline Report – May 2026 5/12/2026

    This WhichTrial report breaks down which drug trials are growing the most and the least, drugs that are no longer being studied, and new drugs to the clinic from March 7 to May 1, 2026. 

35. Executive Order For Psychedelics 5/8/2026

    We caught up with Joseph Tucker, Ph.D., CEO of Enveric Biosciences, to discuss the executive order for psychedelics.

36. 5 Critical Risks With The FDA's Real-Time Trial Monitoring 5/8/2026

    Life science legal experts Kimberly Chew and Odette Hauke cover the FDA proof-of-concept real-time clinical trials (RTCTs) and expose five major issues that must be addressed before the pilot expands.

37. Here's How FDA's Accelerated Approval Pathway Has Evolved Since '24 5/5/2026

    FDA's accelerated approval guidance kicked off a rebalancing of new drug approval pathways. Since its 2024 release, the agency has been building on it in a few key areas.

38. ALS Researchers Use Stratification, Diverse Endpoints To Address Heterogeneity 4/30/2026

    Coya Therapeutics' Fred Grossman dives into innovative trial design elements and a novel biomarker that might better account for clinical and functional progression in Coya's ALS trial studying a dual immunomodulatory therapy.

39. Justice In Human Participant Research: Reinterpreting Belmont For Contemporary Clinical Trials 4/23/2026

    Experienced IRB professional Stephanie Pyle revisits the Belmont Report to consider what its principle of “justice” means for research studies developed and conducted today. 

40. Navigating Elsa's AI Transition: Practical Guidance To Safeguard Confidential Information (Part 3) 4/22/2026

    With FDA's Claude-to-Gemini transition underway within Elsa, Kimberly Chew, Esq., and Michael Yang, Esq., offer advice for proactive risk management to safeguard trade secrets and regulatory outcomes in part three of this series on Elsa's AI transition.