Expert Insights On Data Management & Analysis

  1. 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.

  2. Can Digital Endpoints Really Accelerate Clinical Trials? 8/8/2025

    Digital biomarkers are quickly and quietly becoming the digital revolution needed to make clinical trials quicker and more data rich. Discover how they are being used in clinical trials right now.

  3. EMA Issues Revised Annex 11, New Annex 22, And Associated Documents On Data Governance 8/6/2025

    The EMA issued three new draft documents in July, all related to the advancement of the use of electronic technology in GMP: AI, computerized systems, and documentation. The public comment period ends Oct. 7.

  4. CDISC's New 360i Helps Move Trial Design From Manual To Modern 7/30/2025

    Take a deeper look into the CDISC 360i initiative by discovering 360i's benefits and learning how to get involved in its development and rollout.

  5. AI Data Security: The 83% Compliance Gap Facing Pharmaceutical Companies 7/23/2025

    A new study reveals a shocking truth: only 17% of pharmaceutical companies — including many CDMOs — have implemented automated controls to prevent sensitive data from leaking through AI tools.

  6. What Sponsors Must Know About Digital Systems And AI Compliance 7/17/2025

    Consultant Jessica Cordes provides an update on proposed changes to GMP guidance that affect trial conduct, including documentation, computerized systems, and the use of AI.

  7. More Personalized, Precision Medicine Needed In Psychiatry Clinical Trials 7/16/2025

    Arrivo Bioventures' Joel Raskin, MD, and Greg Rigdon, Ph.D., discuss the importance of personalized and precision medicine in psychiatry clinical trials.

  8. How To Avoid Hazards And Map A Safer, Smarter Path For AI, Part 2 7/15/2025

    The AI journey is full of hidden potholes, unexpected detours, and costly wrong turns. In part two of this series, Tanisha Patel and Vincent Puglia explore more considerations for integrating AI in clinical research.

  9. How To Avoid Hazards And Map A Safer, Smarter Path For AI, Part 1 7/15/2025

    Even with a clear destination with real rewards, the AI journey is full of hidden potholes, unexpected detours, and costly wrong turns. Tanisha Patel and Vincent Puglia explore several considerations when integrating AI in clinical research.

  10. How Is RIM Software Transforming Regulatory Compliance? 6/20/2025

    Regulatory information management (RIM) software tools streamline global regulatory processes on a single cloud-based platform throughout the entire product life cycle.