Clinical Guest Contributors

  1. Decentralized Clinical Trials: Embracing The FDA's 2024 Final Guidance 4/16/2025

    In Sept. 2024, the FDA unveiled a final guidance aimed at advancing decentralized clinical trials. This article shares a summary, describes the differences from the 2023 draft guidance, and provides helpful insight for sponsors.

  2. Japan's Adoption Of DCTs Is Slow But Steady 4/16/2025

    While global momentum for DCTs accelerates, Japanese healthcare institutions face unique structural and operational hurdles to implement remote and digital trial activities.

  3. "A Long Way To Go": Patient Wants Better Listening From Pharma 4/15/2025

    Aspirin exacerbated respiratory disease (AERD) patient advocate Rhonda Nelson shares her patient experience and explains how she thinks pharma companies can better integrate the patient voice into clinical trial design. 

  4. From Tissue Donation To Distribution: Understanding EU Regulatory Requirements In Cell Therapy Clinical Trials 4/14/2025

    Understanding how the European Union's Directive 2004/23/EC interacts with GMP — and where its jurisdiction begins and ends — is essential for successful clinical trial planning, compliance, and execution.

  5. Data Overload: Determining Which Trial Data To Collect 4/11/2025

    Clinical trials collect a substantial amount of participant data, but not all of it is necessary. Learn how to decide what data's needed and what's not.

  6. How HHS Budget Cuts And Vaccine Hesitancy Threaten Clinical Trial Operations — And What Leaders Can Do 4/10/2025

    Prof. Stacey B. Lee, Ph.D., examines how the recent Department of Health and Human Services (HHS) staffing cuts and vaccine hesitancy combine to make clinical research much more challenging.

  7. Smart Trial Design In Cell Therapy: Fast-Tracking Without Compromising 4/10/2025

    Discover clinical trial designs and real-life examples that enable fast and safe studies in cell therapy.

  8. The Risks Of AI In Clinical Research From A Trial Management Perspective 4/9/2025

    In part two of this series, consultant Donatella Ballerini explores the challenges of integrating AI into eTMF management and how to mitigate them.

  9. How AI Models Can Actually Improve eTMF Management 4/8/2025

    GCP consultant Donatella Ballerini explores how AI is shaping eTMF management and what this means for the future of clinical research in part one of this series.

  10. How AI Redefines The Functional Service Provider Opportunity In Medical Affairs 4/7/2025

    Medical affairs can no longer afford to operate within legacy structures. Enter AI-enabled functional service provider (FSP) models that offer operational relief.