Clinical Guest Contributors

  1. The FDA Plausible Mechanism Framework Just Changed Rare Disease Drug Development 3/9/2026

    Discover how the new FDA Plausible Mechanism Framework changes the game for rare disease research by formalizing an approval pathway for individualized treatment of ultra-rare genetic diseases.

  2. Avoid Clinical Alignment Breakdowns With "Lateral Agility" 3/6/2026

    Internal misalignment can stall the clinical timeline, erode the window of patent protection, and jeopardize funding. Learn why leadership can no longer be and instead must exhibit "lateral agility" across the enterprise.

  3. Outsourcing? When Both Sides Of The Table Are Investor-Backed, Everything Changes 3/6/2026

    The outsourcing relationship is increasingly not sponsor versus provider. It is two investor-backed organizations navigating parallel pressures — with a shared program sitting in the middle.

  4. The Latest On RBM Uptake? Tufts Says Most, But Not All, Pharma On Board 3/5/2026

    Tufts CSDD’s Beth Harper shares findings from the org's latest Impact Report and discusses how companies might better define risk, measure success, and understand central monitoring. 

  5. FDA's Draft Guidance On Bayesian Methods: Strategic Implications For Small Biotechs 3/4/2026

    The FDA draft guidance on Bayesian methodology represents a major validation of statistical innovation in clinical development. Jessica Cordes summarizes the latest from the FDA and offers advice for small biotechs.

  6. Adapt Or Die: Best Practices In Designing An Adaptive, Open-Label RCT Phase 3 Oncology Trial 3/3/2026

    Discover how adaptive trial design can deliver greater operational efficiency, improved efficacy outcomes, and enhanced sponsor affordability across the drug development life cycle.

  7. The Uncomfortable Conversation: AI And Data Use In Clinical Trials 3/2/2026

    AI is quietly transforming clinical trials at the site level, boosting efficiency while creating hidden risks for patient data, protocols, and sponsor intellectual property.

  8. When A Clinical Trial Surfaces In An AI Chat, What Happens Next? 3/2/2026

    AI is soon becoming the first interpreter of your clinical trial. Understand its implications for enrollment design, screening efficiency, and ultimately program predictability.

  9. The Cost Of Transactional Thinking In Clinical Research 2/26/2026

    Denise N. Bronner of Empactful Ventures explores the power dynamics at play in clinical research, picking apart the roles of sponsors, vendors, and sites and advocating for a better way to do business among them.

  10. Enabling Cloud Computing In DCTs For Remote Data Capture, Monitoring, And More (Part 1) 2/25/2026

    Understand why cloud infrastructure is foundational to hybrid and decentralized trials and what critical trial activities it enables with reduced operational friction.