Clinical Guest Contributors

  1. New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA 6/9/2026

    NervGen CEO Adam Rogers discussed why choosing a hand function endpoint for tetraplegia made sense for patients and how regulators helped guide and support the company's decision.

  2. The FDA Could Clear The Path For A Strep A Vaccine. Why Hasn't It? 6/8/2026

    Strep A kills around 500,000 people each year, and a vaccine would change this and is within reach. Yet, no strep A vaccine is currently in Phase 3. 1Day Sooner's Josh Morrison explains why and shares how FDA could make Strep A vaccines a reality.

  3. How Acquiring Sponsors Can Keep Post-Acquisition Clinical Operations Running Smoothly 6/5/2026

    When acquiring another company, the acquiring sponsor must preserve operational continuity across active trials while integrating new assets, teams, technologies, vendors, and decision structures. Leila Cupersmith explains how.

  4. 5 Signals Teams Should Track To Avoid Clinical Trial Execution Drift 6/4/2026

    Many teams detect execution drift too late. To stay head, learn how to follow these five governance signals: documentation reliability, ownership clarity, dependency visibility, escalation discipline, and decision-ready review quality.

  5. Lessons In Pivoting From A Clinical Trial Launch In Uganda 6/3/2026

    Gates MRI researchers share how they navigated supply chain challenges, an Ebola outbreak, and evolving regional malaria vaccination strategies to successfully execute a malaria clinical trial in Uganda.

  6. DDW 2026 Signalled The Next Era Of Competitive Landscape In IBD 6/2/2026

    At the DDW 2026 meeting, the IBD landscape was portrayed as increasingly competitive and diversified, with emerging players and novel mechanisms challenging established standards of care.

  7. What Is Computer Software Assurance, And What Are Its Benefits? 6/2/2026

    Kamila Novak reviews final computer software assurance (CSA) guidance and what it means for those working on medical device clinical trials.

  8. The FDA Is Rudderless And Clinical Trials Are Left Adrift 6/2/2026

    Former commissioner Marty Makary, MD, left the FDA in May 2026. In his wake, he left an agency facing yet another wave of uncertainty. Denise N. Bronner attempts to navigate the latest change and offers advice for those seeking stability.

  9. Expanding Access To Cell Therapy Trials Beyond AMCs And Into The Community 6/1/2026

    CEO Paul J. Hastings discusses Nkarta's decision to bring outpatient dosing into the community setting, including how it communicated with the FDA on safety and how the changes will improve patient access. 

  10. What's The Role Of HEOR For A Clinical Researcher? A Perspective From ISPOR 2026 6/1/2026

    On the heels of ISPOR 2026, discover what relevancy HEOR has in the world of clinical operations.