Regulatory Affairs Editorial

  1. An Expert Guide To Effective Sponsor Oversight In Clinical Trials 10/8/2024

    Consultant Jessica Cordes explains how combining thorough sponsor oversight with robust risk management practices, sponsors can significantly enhance the quality and reliability of clinical trials. 

  2. The Crucial Role Of Sponsor Oversight In ICH E6 (R3) 10/7/2024

    ADRES Bio leaders Inbal Hacmon and Rivka Zaibel delve into the critical aspects of ICH E6 (R3), shedding light on its implications for clinical trial sponsor responsibilities.

  3. Massive Data, More Decentralization Drive Updates To ISPE GAMP Guide 10/4/2024

    ISPE GAMP Guide lead author Frank Henrichmann describes the changing clinical data environment and details updates that will support the work of various clinical trial stakeholders. 

  4. Continuing Rare Disease Treatment With A Compassionate Use Program (CUP) 10/2/2024

    Learn how Rezolute successfully led its investigational drug for treating congenital hyperinsulinism (cHI) through a compassionate use program.

  5. Compassionate Use Program (CUP) Benefits & Strategies In Rare Disease 10/2/2024

    In part two of this series, Rezolute discusses the benefits of continuing patient care with a compassionate use program (CUP) and shares best practices for implementing one.

  6. Research, Manufacturing, Regulatory, And More: What Are The Challenges With CGTs? 9/27/2024

    UCB Head of U.S. Research Roger Palframan discusses the challenges with CGTs — from complex manufacturing to the need for greater and more meaningful patient engagement to evolving regulations and reimbursement.

  7. Why Sponsors And Sites Must Prioritize Coverage Analysis In Clinical Trials 9/26/2024

    Huron Consulting Group's Casey Charlton explains why conducting a coverage analysis (CA) is a crucial step in the pre-award workflow for sites participating in clinical trials.

  8. The Value Of A High-Performing Regulatory Function Within A CRO 9/25/2024

    Consultant Pete Embley discusses the value a regulatory expert brings to both CROs and sponsors alike.

  9. Key Takeaways From Clinical Trial Diversity Discussion 9/24/2024

    During the Clinical Leader Live, The Diversity Mandate: Effective Strategies in Clinical Trials”, we discussed everything from the guidance, to diversity action plans, to the need for better data on race, ethnicity, and identity. In this article, we also share 25 questions audience members had regarding this hot topic.

  10. Why Sponsors Must Check For Site GCP Adherence During Feasibility Studies 9/19/2024

    GCP consultant Donatella Ballerini explores how adherence to GCP influences site feasibility, shaping the success and credibility of a clinical trial.