Clinical Guest Contributors

  1. How Important Are Medical Monitors Under ICH E6(R3)? 3/20/2026

    Discover how medical monitor-led implementation of ICH E6(R3) outperforms operations-only models across six critical performance dimensions.

  2. Old Habits, Communication Issues Still Stalling Site Budget Negotiations 3/19/2026

    Drawing from the 2025 SCRS Landscape Survey Report, Jimmy Bechtel and Ken Getz unpack how growing trial complexity, inconsistent fair market value benchmarks, and structural disconnects are reshaping site-sponsor relationships.

  3. The Art Of Finding And Keeping The Right KOL 3/18/2026

    Learn from Incyclix CEO Patrick Roberts how the company identifies its KOLs, tailors engagement to their expertise, measures collaboration success, and sustains successful long-term partnerships.

  4. What To Look For In Rare Disease Partnerships, With Origami's Beth Hoffman 3/17/2026

    Origami Therapeutics CEO Beth Hoffman shares how the company took both a measured and a gut-feeling approach to finding the right partner to supports its development of protein degraders for neurodegenerative diseases.

  5. Lessons From Bringing A Novel T Cell Class For Autoimmune Diseases Into The Clinic 3/13/2026

    Tr1X Bio Co-founder and CEO David de Vries explains how moving Type 1 regulatory T Cell (Tr1) therapies into new indications reshapes every facet of first-in-human trial design.

  6. PolarityBio Loosens I/E And Taps Many Provider Types To Reach More Patients 3/13/2026

    Discover how PolarityBio widened enrollment criteria and even developed improved delivery model to better serve investigators and patients in its Phase 3 trial for diabetic foot ulcers.

  7. FDA's Elsa AI Switches From Claude To Gemini: What Sponsors Need To Know 3/12/2026

    Forced to cease using Anthropic's Claude for its Elsa generative AI assistant, the FDA is switching to Gemini. Legal experts Kimberly Chew, Esq., and Michael Yang, Esq., explain the implications for trade secrets and data security risks.

  8. How The ACA Subsidy Lapse Could Hurt Clinical Trial Enrollment 3/12/2026

    The relationship between the Affordable Care Act (ACA) enhanced premium subsidies and clinical research isn’t widely understood, so consultant Devra Densmore is clearing things up, including how coverage loss could impact trial enrollment.

  9. Patient-Powered Drug Trials Are Getting The FDA Greenlight 3/12/2026

    Patient- and parent-led drug development is on the rise, with the latest effort securing FDA clearance for a gene therapy trial. Yet, they are largely invisible. Buffalo Initiative plans to change that.

  10. When Sponsors Can't Explain How Study Data Flows, Inspection Readiness Breaks Down 3/11/2026

    Regulators want one thing during inspections — to see how the data flows, says Just In Time GCP's Donna Dorozinsky. Here, she explores the importance of data oversight and where sponsors sometimes go wrong.