Featured Editorial

1. How To Operationalize AI-Enabled eTMF Systems Under The EU AI Act (Part 2) 2/12/2026

   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.

2. How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1) 2/12/2026

   Learn how the EU AI Act reshapes the regulatory treatment of AI-enabled eTMF systems with consultant Donatella Ballerini.

3. Making AI Safety Routine: How Sites And Sponsors Can Continuously Monitor Clinical AI 1/29/2026

   Learn why the next frontier in AI governance will involve real-time surveillance of algorithmic performance across institutions with guidance from Akshaya Bhagavathula and Michelle A. Williams.

4. How Can AI Change Computerized System Validation? 1/27/2026

   Learn how AI technologies are changing the computer system validation (CSV) landscape and what you need to understand about this transformation.

5. Digital Tools Are Failing Patients: 3 Ways Clinical Supply Can Protect Data Integrity 1/16/2026

   Getting drugs and devices to the doorstep is only half the battle. When digital connections fail, trials fail. Why the digital last mile needs clinical supply ownership, human-centered design, and tech support with a bedside manner.

6. Virtual Reality Endpoints Improve Measurement Of Patients' Real-World Benefit 1/12/2026

   Opus Genetics CEO George Magrath, MD, discusses how the company introduced virtual reality-enabled assessments and relied on digital endpoints to better measure participants’ vision changes.

7. Can't-Miss Advice On Selecting Your First AI-Enabled Vendor 12/12/2025

   Quarles & Brady's Simone Colgan Dunlap and Meghan O’Connor offer actionable guidance to help sponsor companies make informed, strategic choices in an evolving AI market.

8. The Site Perspective: Why Ambient AI Is The Missing Link In Clinical Trial Data Integrity 12/10/2025

   Discover how AI ambient listening has changed the way Mikel Daniels, DPM, MBA, and his team conduct clinical research at WeTreatFeet Podiatry. 

9. Why HEOR Keeps Arriving Too Late — And How ClinOps Can Fix It 12/9/2025

   Rob Abbott, CEO of ISPOR, breaks down why HEOR timing keeps clashing with ClinOps timelines and offers practical ways to integrate value, evidence, and payer expectations much earlier in development.

10. Accelerating Clinical Innovation With Open-Source Medical Platforms 12/8/2025

    Openwater CEO Aaron Timm shares how open source can reduce the cost of technology and extend its reach to more hospitals, researchers, and patients.