Downloads

1. What's Wrong With Site Benchmarking? A Site-Centered Perspective On Its Alignment, Transparency, And Use 6/9/2026

   Benchmarking is widely used and highly valued, yet trust in it is limited. The League Benchmarking Working Group has set out to standardize how site metrics are defined, contextualized, and applied.

2. 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.

3. 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.

4. Incorrect Clinical Trial Enrollment Is Preventable. A Tale Of Three Case Studies 6/5/2026

   See how three clinical trials used centralized eligibility review to accelerate enrollment, eliminate enrollment-based protocol deviations, and keep studies on track, even at a global scale.

5. 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.

6. Successful SwissMedic Marketing Authorization Application For An Oncology Therapy 6/4/2026

   See how strategic EU dossier adaptation and Swiss-specific regulatory expertise enabled a successful SwissMedic submission and accelerated market access for an oncology therapy.

7. End-To-End Clinical, Biometrics, And Regulatory Support In Neurology 6/4/2026

   Discover how an integrated NDA strategy aligned data, vendors, and regulatory execution to achieve an on-time submission and approval without major FDA queries.

8. 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.

9. Real-World Insight: How Integrated Oversight Prevents Unnecessary Trial Disruptions 6/3/2026

   Integrated oversight helps teams interpret early safety signals in context, enabling targeted action, reducing escalation, and preventing disruptions in complex studies with limited data.

10. From Startup To Signal Detection: Building An Integrated Safety Framework 6/3/2026

    Early alignment, continuous collaboration, and unified decisions help teams spot safety signals sooner, streamline responses, cut amendments, and strengthen patient protection across clinical trials.