Clinical Guest Contributors

  1. Trends In Rare Disease Trials: Trial Designs, Challenges, And Regulatory Progress 10/13/2025

    Beroe Inc. Lead Analyst Sapan Rani unpacks the evolution of trial design types in rare disease research, analyzes ongoing challenges, and examines how regulatory support is enabling innovation in part one of this three-part series.

  2. How Enveric Biosciences Is Prepping For Its First IND 10/10/2025

    Enveric Biosciences CEO Joseph Tucker, Ph.D., discusses how the team is finalizing IND-enabling studies, leveraging both in-house expertise and trusted external partners.

  3. Oncology PI Shares Lessons Learned And Successes Working With Basic Scientists 10/9/2025

    Ranee Mehra, MD, shares her successes and discusses how they shape her approach to future research, as well as details the importance of working closely with basic scientists.

  4. Post-Trial Access: Compliance Lessons Hidden In Plain Sight 10/8/2025

    What happens when the trial ends and the investigational product is no longer available? Edye T. Edens, JD, MA, CIP, CCRP, talks through the answer.

  5. What Sites Wish Tech Vendors (And Sponsors) Heard At SCDM But Probably Didn't 10/8/2025

    During a Society for Clinical Data Management (SCDM) panel discussion, three site-side representatives discussed the challenges clinical research coordinators have executing their clinical duties amid increasingly complex data entry demands.

  6. SCDM 2025: Practical Advice From Global Regulators — Including The FDA 10/6/2025

    Discover what regulators from around the world, including the FDA, think should be top of mind for clinical data managers.

  7. Mastering The Monitoring Visit: Key Tips For Site Success 10/6/2025

    The ACRP Atlanta Chapter recently hosted a Lunch-n-Learn session on “Mastering the Monitoring Visit: Key Tips for Site Success.” The conversation highlighted the shared goal of CRAs and CRCs: ensuring compliance, protecting data integrity, and making monitoring visits a collaborative — not adversarial — experience.

  8. Import Product Specifications And Drug Registration Testing For China 10/6/2025

    This overview and its recommendations are valid for drug registration testing (for marketing authorization application in China) as well as import testing (for commercial batches to be imported to China after approval).

  9. How One Biopharma Company Overcame Trial Failure 10/6/2025

    PolyPid's Eyal Shoshani highlights the company's second attempt at its SHIELD trial, including things they did to revamp the trial design and the impact of AI in this and future trials.

  10. How Government Shutdowns Set Back Clinical Trials 10/3/2025

    When the federal government shuts down, clinical research suffers. Empactful Ventures' Denise N. Bronner, Ph.D., explains the wide-reaching ramifications.