GUEST COLUMNISTS

• How The Quiet Data Standards Revolution Is Impacting Drug Approval

  Principal Statistical Programmer Varun Debbeti details the role data standards play in approval timelines, detailing shortfalls of current the model and CORE, Dataset-JSON, and SDTM v3.0 stand to make an impact.

• Designing Trials For Disease Modification: Cereno Scientific's Approach To Pulmonary Arterial Hypertension

  Cereno Scientific’s Rahul Agrawal discusses the scientific and strategic rationale behind extending the company’s Phase 2b study duration and how the company incorporated regulator and patient input.

• What's Wrong With Site Benchmarking? A Site-Centered Perspective On Its Alignment, Transparency, And Use

  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.

• New Primary Endpoint For Tetraplegia Drug Gets Support From Patients And The FDA

  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.

• The FDA Could Clear The Path For A Strep A Vaccine. Why Hasn't It?

  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.

• How Acquiring Sponsors Can Keep Post-Acquisition Clinical Operations Running Smoothly

  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.

• 5 Signals Teams Should Track To Avoid Clinical Trial Execution Drift

  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.

• Lessons In Pivoting From A Clinical Trial Launch In Uganda

  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.