Clinical Guest Contributors

  1. Run Better Trials By Rewriting The CRA-Site Relationship Playbook 4/29/2025

    Senior CRA Bryce Nichols explains how sites can use their CRAs — beyond their monitoring duties — to improve site efficiency, communication, and trial success.

  2. Sponsor Oversight Strikes Back: Outsourcing Everything But The Responsibility Under ICH E6 (R3) 4/28/2025

    If E6 (R3) is ushering in the era of Quality by Design, clinical development consultant Angus Henderson says it's time we talk seriously about oversight by design.

  3. The Future of Glaucoma Therapy: Adaptive Trial Design and Patient-Centric Protocols 4/25/2025

    Perfuse Therapeutics' Sevgi Gurkan, MD, discusses the company’s use of functional and structural endpoints, exploratory biomarkers, adaptive trial design plans, and patient-centric protocol development.

  4. Promising Clinical Trial Updates Shared At The American Academy Of Neurology Conference 4/24/2025

    The 2025 American Academy of Neurology (AAN) conference in early April saw some promising clinical trial updates treating Guillain-Barre Syndrome and Huntington’s Disease, CIDP, and ALS.

  5. Track Your Trial's Carbon Footprint With This Sustainability Calculator 4/24/2025

    Pistoia Alliance Portfolio Lead Thierry Escudier discusses the latest updates to the Clinical Trial Carbon Calculator.

  6. Unsure About The New ICH Guidelines? TransCelerate Debuts 13 Tools To Help 4/23/2025

    TransCelerate BioPharma's Tashan Mistree discusses 13 new tools created alongside the Association of Clinical Research Organizations (ACRO) to support ICH GCP E6(R3) adoption.

  7. Racial Inequities In Medicine: The Consequences Of Historical Unethical Experimentation In Clinical Trials 4/22/2025

    In part two of this series on racial inequities in clinical research, the authors discuss the impact those trials have had on clinical research in the Black community, especially for women.

  8. Racial Inequities In Medicine: The History Of Unethical Race-Based Experimentation 4/21/2025

    Unethical and even brutal clinical research of the 19th and 20th centuries targeted the Black community. Discover how the medical mistreatment of Black patients and participants shaped how the community sees trials today.

  9. Decentralized Clinical Trials: Embracing The FDA's 2024 Final Guidance 4/16/2025

    In Sept. 2024, the FDA unveiled a final guidance aimed at advancing decentralized clinical trials. This article shares a summary, describes the differences from the 2023 draft guidance, and provides helpful insight for sponsors.

  10. Japan's Adoption Of DCTs Is Slow But Steady 4/16/2025

    While global momentum for DCTs accelerates, Japanese healthcare institutions face unique structural and operational hurdles to implement remote and digital trial activities.