Clinical Trial Technology Editorial

  1. Understanding And Preserving Data Flow Integrity In AI-Assisted Clinical Trials 6/26/2026

    Learn from ex-FDA and ELIQUENT consultant Dawn Wydner, Ph.D.., how treating data integrity as an end-to-end clinical information flow issue, rather than a database-only concern, is essential to managing AI-related risk.

  2. AI Can Help Design Better Trials, But It Still Can't Tell You Whether Patients Will Join Them 6/25/2026

    AI is changing the way clinical trial trials are discussed, planned, and designed. But even with an improved protocol, are AI-enhanced trials driving better enrollment?

  3. Will AI And Agile Project Management Help Advance RBM? 6/24/2026

    Will AI-based tools embedded into risk based-monitoring prompt an Agile project management moment for clinical research? Sidharth Ananthanarayan explains why AI-based tools are not the answer but part of it.

  4. A Sponsor Playbook For Matching AI Use Cases To Readiness, Risk, And ROI 6/18/2026

    Clinical technology consultant Karen Maduschke explains why your next AI investment should solve a problem you can articulate, with data you can access, in a process you can change.

  5. 3 Views From Inside FDA's RTCT Pilot 6/5/2026

    The FDA's RTCT pilot promises to bring clinical trials into the real-time era, but questions remain about governance, oversight, and implementation. We asked three organizations participating in the initiative what they see as the opportunities, challenges, and realities behind the FDA's most ambitious modernization effort in years.

  6. What Is Computer Software Assurance, And What Are Its Benefits? 6/2/2026

    Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.

  7. My View: The Clinical Trials Technology Congress 5/26/2026

    I attended the inaugural Clinical Trials Technology Congress in London expecting to hear plenty about AI, digital tools, and the future of clinical trials. What stood out instead was how many speakers focused on a much more immediate issue: reducing complexity for sites, patients, and study teams.

  8. 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.

  9. 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.

  10. 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.