Clinical Data Management Featured Articles

  1. Powering Standards With Code: The Role Of Open Source In CDISC 360i 9/26/2025

    Discover how to implement CDISC standards in automated research data pipelines that are fast, scalable, and reliable.

  2. When "Imperfect" AI Models Still Add Value In Pharma Quality 9/24/2025

    AI isn't perfect, and that's OK, says ERA Science's Andy O'Connor. Here, he contends that if we can prove and explain how a human+AI process outperforms a human-only process, then imperfection is still progress.

  3. RWD Helps Abbvie Bridge Oncology Trial Data Gaps 9/18/2025

    AbbVie Vice President of Global and U.S. Medical Affairs Oncology Svetlana Kobina, MD, Ph.D., discusses how integrating real-world data (RWD) with RCTs can fill critical data gaps.

  4. RFK Jr. Wants Every American Wearing A Wearable. How Can Pharma Build A Business Around It? 9/16/2025

    The timing is now for pharma to be all-in on using wearables as their new business strategy, says Digital Medicine Society (DiMe) Director of Partnerships Smit Patel, PharmD.

  5. 4 Steps To Make A Business Case For Digital Endpoints 9/12/2025

    Anita Burrell explains how to build a business case for including digital endpoints and the elements to consider.

  6. How Digital Twins Are Rewriting Clinical Trials 9/2/2025

    While the benefits of digital twins to accelerate clinical trials are undeniable, many questions about their use are still unanswered and go far beyond technology.

  7. 3 Quick Takes From A PI With 100+ Trials To His Name 8/29/2025

    Principal investigator Norman B. Gaylis, MD, shares his perspective on patient recruitment, protocol design, and vendor selection.

  8. Where The FDA And EMA Stand On Digital Endpoints 8/22/2025

    In part two of this series on digital endpoints, consultant Anita Burrell reviews the extent of their regulatory acceptance and discusses how to ensure data produced from digital technologies satisfies regulators.

  9. How AI Can Accelerate Clinical Trials' Probabilities Of Technical And Regulatory Success (PTRS) 8/21/2025

    AI expert Kelly H. Zou, Ph.D., explores how the technology can drive R&D successes, including clinical trials.

  10. Closing The Gender Gap In Clinical Trials With Digital Devices 8/15/2025

    For decades, women have been underrepresented in clinical trials — a gap that’s not just unfortunate but dangerous. Digital devices might be the difference maker, says research physician Anita Phung, MRGCP, MRCP, MBBS, BSc (Hons).