Clinical Guest Contributors

  1. 5 Cs For Responding To FDA-483s — Strategies For Effective Compliance And Resolution 7/29/2025

    Former FDA Director of Bioresearch Monitoring Division (West) Eric Pittman, MBA, shares his top five tips for responding to FDA-483s.

  2. Age Restrictions In Clinical Trials Unjustly Harm Adults With Childhood Cancer 7/28/2025

    How old is too old for a pediatric cancer trial? Mom-turned-patient advocate Rosemary Sherrod argues that too-stringent age criteria wrongly exclude pediatric cancer patients as they approach adulthood.

  3. 5 Best Practices For Improving AI Literacy In A GxP Environment 7/25/2025

    ERA Sciences' Ben O'Brien shares five tips to improve pharma and biotech companies' AI literacy when operating in a GxP environment.

  4. 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.

  5. All Of Us Need To Be Rooting For The FDA 7/23/2025

    In light of FDA leadership changes and operational updates, FDA Matters' Steven Grossman asks us all to slow down and consider why we should be cheering on, not tearing down, the present-day FDA.

  6. Why Is Hep C Still On The Rise? And What Atea Is Doing About It 7/22/2025

    Atea Pharmaceuticals Chief Development Officer Janet Hammond, MD, Ph.D., discusses why current DAAs aren't adequately addressing the rise in hepatitis C and how Atea is hoping to curb the increase.

  7. 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.

  8. 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.

  9. 4 Centralized Comparator Sourcing Models To Fortify Supply Chains 7/15/2025

    A team at Novartis developed models to address the often-overlooked challenge of clinical trial comparator sourcing, a weak link that can derail trials.

  10. 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.