From The Industry Experts

  1. The Compound Effect Of Specialized Knowledge 5/22/2026

    How does specialized knowledge compound over time into foresight, stronger execution, and more confident decision-making across the drug development lifecycle?

  2. Measuring What Can't Be Seen: How PTSD Clinical Trials Prove A Drug Works 5/22/2026

    PTSD trials expose one of the hardest problems in modern drug development, a reliance on clinician-administered and patient-reported scales to determine whether a therapy truly works.

  3. Synaptic Regeneration And The Future Of Alzheimer's R&D 5/22/2026

    For too long, treating Alzheimer’s disease has been a case of “managed decline.” We need to move beyond slowing disease progression toward achieving tangible functional recovery.

  4. FDA Form 483 Responses: The Difference Between Explaining An Observation And Demonstrating Control 5/22/2026

    ADRES Bio's Rivka Zaibel walks sponsors through the proper response to an FDA Form 483, emphasizing the need to show understanding and control of the situation.

  5. The Regulatory Governance Gap In Clinical Trial AI 5/21/2026

    Regulators are no longer questioning whether AI belongs in clinical trials; however, they’re demanding a governed infrastructure that makes every AI-driven decision auditable and defensible.

  6. Real-Time Review Is The Most Underrated FDA Story Of The Year 5/21/2026

    The FDA’s real-time review pilot signals a massive shift in clinical operations, where continuously regulator-ready data becomes the foundation of future trial execution.

  7. Capture Was Step One. Execution Is Step Two. 5/21/2026

    Electronic data capture transformed clinical trials, but advancing a study depends on decision workflows that interpret data, coordinate teams, and determine meaningful next actions.

  8. Judgement-Based Project Management Builds Partners' Trust 5/21/2026

    Project managers often operate under rules that govern how and when they execute tasks. But that doesn't always include room for individual judgment. But judgement, argues Jason Bork, is the differentiator in successful partnerships.

  9. Timing And Data Are Critical To Winning BTD For Rare Disease Drugs 5/20/2026

    Breakthrough Therapy designation (BTD) can accelerate rare disease drug development—but timing and evidence are everything. Learn how to position your program for FDA success.

  10. How Did You End Up In Clinical Research? 5/20/2026

    To commemorate Clinical Trials Day, we asked clinical researchers to share their story, answering, "How did you get into clinical research?"