Clinical Guest Contributors

  1. 4 Clear Trends In Outsourced Clinical Services 8/4/2025

    Discover the four dominant trends in outsourced clinical and eClinical services for 2025, with insights derived from an annual survey by L.E.K. Consulting.

  2. Why Are We So Afraid To Pay Research Participants? 8/1/2025

    Clinical researchers have long toiled over paying trial participants. Now, 1Day Sooner patient advocates explain why ethics and actual regulator sentiment should move industry to change its approach to participant payment.

  3. J&J Taps Tau-Based Diagnostics To Improve Alzheimer's Disease Trial Design And Enrollment 7/31/2025

    Johnson & Johnson's Fiona Elwood, Ph.D., discusses the potential of tau-based diagnostics to help design better trials and improve patient enrollment in Alzheimer's disease studies.

  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. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.