Clinical Guest Contributors

  1. Beyond The IND Clock: The Legal Architecture Of QRIs And What Industry Must Say Before July 22 (Part 2) 7/10/2026

    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.

  2. The Profit Margin Double Standard That Needs To Change 7/10/2026

    We expect pharmaceutical companies to have sizable profit margins, but we collectively scoff at research sites for achieving the same. Maria P. Ladd explores this difference in expectations and why it needs to change for the sake of the industry.

  3. How Clinical Research Site Operating Models Perform in Practice – Part 2 7/9/2026

    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.

  4. Project Management And AI: What Should Be Automated And What Should Not 7/9/2026

    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).

  5. Why Operating Model Is The Next Competitive Frontier In Clinical Research Site Strategy – Part 1 7/8/2026

    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.

  6. Before AI Can Transform Clinical Trials, It Needs More Patient Data 7/7/2026

    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.

  7. How One Researcher's Personal Study Experience Is Helping Him Better Serve Patients 7/6/2026

    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.

  8. i-Cubed Used End-To-End AI In A Proof-Of-Concept Trial. Here's What They Learned 7/2/2026

    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.

  9. Social Media Is Replete With Patient RWD, But How Can Researchers Best Use It? 7/1/2026

    Pistoia Alliance's Thierry Escudier and Aditya Tyagi discuss how social media listening is used in clinical research, how it supports established evidence-generation methods, and how it can become a credible, structured input for drug development.

  10. How Translational Biomarker Research Could Change The Trajectory Of Hidradenitis Suppurativa 6/30/2026

    Elisa Maggioli, Ph.D., explains that improving outcomes in HS may depend on moving beyond broad, symptom-based approaches toward more targeted, biologically informed strategies.