Clinical Guest Contributors

  1. Elsa's AI Model Migration: Technical, Compliance, And Regulatory Risks For Sponsors (Part 2) 3/26/2026

    In the second part of their series on Elsa AI model migration, Kimberly Chew, Esq., and Michael Yang, Esq., analyze the risks to compliance and data residency, as well as the integrity of the regulatory record.

  2. Site Staffing On The Upswing, But Still A Challenge 3/26/2026

    In this final article of the series, Jimmy Bechtel and Ken Getz discuss how workforce pressures have shaped site performance and what’s being done to strengthen site staff retention and career growth.

  3. From Real-World Data To Real-World Impact: Building The Evidence Capability Pharma Actually Needs 3/25/2026

    Learn how companies that treat RWE as an operational capability will be better positioned to design more efficient trials, accelerate therapy adoption, strengthen payer negotiations, and demonstrate value across the healthcare ecosystem.

  4. Zymeworks Shares Its Design Rationale (And Wins) In Early-Phase ADC Trials 3/24/2026

    Zymeworks CMO Sabeen Mekan, MD, explores how scientific gains in ADC therapies have influenced first-in‑human trial design.

  5. A Clinical Machine Learning Operations (MLOps) Maturity Framework For Biopharma 3/24/2026

    Pharma has invested substantially in machine learning applications, but investment in the operational infrastructure — the MLOps layer — has lagged. The time to build that infrastructure is now — not after your next trial fails.

  6. Don't Let The Nocebo Effect In Psychedelic Trials Become A Regulatory Problem 3/23/2026

    When a patient feels no effect or a worsening effect because a known treatment effect was or wasn't experience, that's the "nocebo" effect. Strategic Advisor Jama Pittman discusses how this effect could impact regulatory reviews.

  7. Are You Liable? What All Clinical Stage Companies Should Understand About Risk Disclosure 3/20/2026

    Barnes & Thornburg partner Seth Mailhot provides a primer on risk disclosure and how sponsor companies can prepare for and mitigate issues that might arise.

  8. 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.

  9. 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.

  10. 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.