GUEST COLUMNISTS

• 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.

• How AI-Enabled eTMF Systems Are Impacted By The EU AI Act (Part 1)

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

• These Four Things Are Helping Minovia Therapeutics' Rare Disease Trials

  Minovia Therapeutics shares the importance of careful site selection, specialized operational expertise, multidisciplinary collaboration, and innovative trial design as it prepares for pivotal this year.

• Heard At SCOPE: Pharma Wants ROI For Patient Data Return, Diverse Enrollment

  Twice I heard “ROI is the elephant in the room.” Two different panel discussions, two different tracks. 

• What ChatGPT Ads Will Really Mean For Clinical Trials

  AI health assistants may be used to surface clinical trials earlier in patient journeys, and advertising inside conversational AI is best understood as the next logical step in that same progression.

• The FDA Calls For Culturally-Informed Research, But What Do We Understand About The Sikh Community?

  Despite the size and visibility of the community — and the call for diverse patient research — there remains a gap in available health data specific to the Sikh community in the U.S.