Clinical Guest Contributors

  1. Using Critical To Quality (CtQ) Factors To Identify The Critical Data For RBQM 1/2/2025

    Based on ICH E8(R1) quality by design (QbD) principles, experts explain the use of critical to quality (CtQ) factors to identify critical data that focuses the end-to-end RBQM process on patient safety and trial results.

  2. How AI Will Transform Health Equity In Clinical Trials In 2025 12/23/2024

    Click Therapeutics' CMO/CSO Shaheen Lakhan, MD, Ph.D., FAAN explains how the shift toward AI is the first step in addressing diversity in clinical trials.

  3. AI Won't Save Us: Why We Must Save Ourselves 12/20/2024

    We need to bring automation, technology, and AI to the true bottlenecks of drug development — not just the early discovery phases or broader topics such as site selection but the nuts and bolts of clinical trial execution. AI can help reduce the day-to-day burden on clinical trial sites, automate repetitive tasks, and minimize the manual work that adds no value but leads to burnout.

  4. What Future Laboratory Manuals Should Look Like 12/20/2024

    In the final article of this series on lab manuals, FlexPoint Bio Founder and CEO Elena Sinclair imagines what the perfect lab manual might look like — and how to make it a reality.

  5. How Laboratory Manuals Fail Sites And Sponsors 12/19/2024

    In part one of this series, FlexPoint Bio Founder and CEO Elena Sinclair describes the hazards of poorly designed (and followed) clinical trial lab manuals.

  6. Lab Manual Gaps: Sabotaging Data One Sample At A Time 12/19/2024

    In part two of this series on lab manuals, FlexPoint Bio Founder and CEO Elena Sinclair discusses the criticality of sample and process quality.

  7. Feels Like Home: Designing Sites For Patient Comfort 12/18/2024

    Cold, stark, and purely functional, healthcare settings have long lacked the comfort and familiarity of home — until now. Uncommon Cures has used the science of hope to inspire its cozy, comfortable new trial site.

  8. Sick, Well, Or Somewhere In Between: Understanding The Patient Decision To Enroll In A Clinical Trial 12/18/2024

    Participating in clinical research involves profoundly personal and practical psychosocial considerations. Clinical Behavioral Healthcare Specialist Emily Epstein explains.

  9. BeiGene Details Its Approach To Expanding Oncology Trials Into Brazil 12/17/2024

    In this second article, BeiGene's Lígia Campos details its journey to setting roots in Brazil, sharing its beginnings there and highlighting its approach to study start-up and patient recruitment and enrollment.

  10. BeiGene Explains The Landscape Of Oncology Trials In Brazil 12/16/2024

    In part one of this two-part series, BeiGene's Brazil and LATAM clinical operations head Lígia Campos details Brazil's cancer treatment landscape and the benefits of expanding oncology trials there.