GUEST COLUMNISTS

• Time Is Lives: How Collaboration And Urgency Are Rewriting The Future Of Rare Disease

  The inflection point has arrived, says Rob Freishtat, MD, MPH. Understand how collaboration will rewrite how we think of rare disease clinical research.

• The Problem With Excluding Children From GLP-1 Trials In The U.S.

  In the U.S., roughly 15 million children are obese. But many are excluded from GLP-1 research. Obesity expert Evan Nadler, MD, explains why that's problematic.

• U.S. Pharma Tariffs And MFN In 2026: Manufacturing And Procurement Impact

  Beroe Inc.'s Mathini Ilancheran discusses the 2025 U.S. pharma tariff framework and translates it into actionable procurement and outsourcing responses.

• How AI-Enabled Personal Health Tools Are Reshaping Clinical Trial Workflows

  Learn how AI-enabled personal health technologies are impacting key aspects of trial operations while also exploring operational challenges that clinical operations leaders must manage in this AI-driven era.

• 4 Steps For Representative Enrollment In Rare Disease Trials

  Discover the D.A.T.A. method and its utility in enrolling diverse representative patient populations in rare disease clinical trials.

• When AI Meets Accounting: AI Costs And Intangible Asset Treatment For Sponsors And CROs

  Learn how to account for AI-related costs under evolving U.S. Generally Accepted Accounting Principles (GAAP).

• FDA Issues Final Guidance On Clinical Trial Participation: What You Need To Do Now

  On December 15, 2025, the FDA finalized its guidance Enhancing Participation in Clinical Trials, formally updating expectations for enrollment and trial design. Here's what you can do now.

• How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2)

  Learn how to comply with the EU AI Act when AI is used in GCP-critical eTMF contexts in part two of this series by Donatella Ballerini.