GUEST COLUMNISTS

• Beyond The IND Clock: What Operation TrialBlazer Gets Right — And Where It Stalls (Part 1)

  The FDA's Operation TrailBlazer includes a proposal to speed up IND review and approval. But will it work? Kimberly Chew and Odette Hauke identify where the initiative succeeds and where the structural gaps begin.

• Beyond The IND Clock: The Legal Architecture Of QRIs And What Industry Must Say Before July 22 (Part 2)

  The FDA's Operation TrailBlazer includes a proposal to speed up IND review and approval. But Kimberly Chew and Odette Hauke say its legal architecture is unresolved and reveals compliance issues that are hard to ignore.

• Project Management And AI: What Should Be Automated And What Should Not

  How can clinical research project management be optimize by AI? To determine its best fit, consultant Jason C. Bork assess AI's utility in project management through the lens of Plan, Do, Check, Act (PDCA).

• How Clinical Research Site Operating Models Perform in Practice – Part 2

  In part two of this three-part series, Paradigm Clinical Research CEO Kurt Mussina evaluates how each site operating model performs regarding speed, patient access, investigator engagement, quality, accountability, and scalability.

• Why Operating Model Is The Next Competitive Frontier In Clinical Research Site Strategy – Part 1

  In this three-part series, Paradigm Clinical Research CEO Kurt Mussina discusses the meaningfulness of a site's operating model to clinical trial sponsors. In part one, he first defines operating model types.

• Before AI Can Transform Clinical Trials, It Needs More Patient Data

  King’s College London Professor Maddy Parsons says AI won't improve clinical trials — unless researchers begin collecting richer biological data, embracing diversity, and treating every clinical trial as learning opportunity.

• How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients

  Regeneron Executive Director in Clinical Sciences Kaniel Cassady, Ph.D., reflects on how his industry experience shaped his expectations, questions, and interactions as a patient in a clinical trial and how his patient experience is reshaping his clinical work going forward.

• i-Cubed Used End-To-End AI In A Proof-Of-Concept Trial. Here's What They Learned

  Discover how well AI fared in document generation, patient engagement, data integration, and more in an end-to-end proof-of-concept study run by i-Cubed.