All Content Clinical Leader

  1. Mock Inspection Advice From Former Regulatory Investigator 12/30/2025

    Former FDA investigator Alia Legaux, D.H.Sc., runs through her top tips for running a mock investigation.

  2. FDA Further Expands And Clarifies Expanded Access FAQs 12/29/2025

    Healthcare attorney Dianne J. Bourque breaks down the FDA's October 2025 update to its Expanded Access FAQs.

  3. The Hidden Work That Keeps AMC Trials Moving 12/29/2025

    After a chance LinkedIn connection led to a conversation with Paul Antaby of MD Anderson, I got an inside look at how clinical trials really operate inside a major academic medical center. From material transfer agreements and data governance to recruitment, scale, and CRC burnout, this interview reveals the hidden work that keeps AMC trials moving — and why they operate so differently from community sites.

  4. The Rise Of Antimicrobial Resistance And Strategic Research Imperatives For 2026 12/26/2025

    Antimicrobial resistance (AMR) has increasingly worried public health officials and researchers alike in 2025. Now, in 2026, TAXI Pharmaceutical President and CEO Gregory G. Mario, MBA, is calling for more targeted approaches and the integration of AI for quicker discovery and development.

  5. Is Your Team Burnt Out? Discover The ROI Of Healthy Employees Running Trials 12/23/2025

    Clinical trials require attention to detail, but one key variable is often overlooked: the physical, mental, and emotional wellbeing of the people behind the science and operations. How can companies make sure their workforce is ready and able to perform in high-stakes drug development?

  6. Avance Clinical Launches Diversity In STEM Scholarships Across Australia And North America 12/22/2025

    Avance Clinical, the award-winning global CRO for biotechs, has announced the launch of its new Diversity in STEM Scholarships, a global initiative designed to support women and minority-group students pursuing careers in science, technology, engineering, and mathematics (STEM). The program includes dedicated intakes in Australia and the broader Asia-Pacific region, as well as North America, reinforcing the company’s commitment to equity and inclusion in clinical research.

  7. 6 Pillars To Support Community Hospitals' First Steps Into Clinical Trials 12/22/2025

    Discover six pillars community hospitals can leverage to make a compelling case for clinical trials: dedicated infrastructure, community engagement, technology platforms, financial support, strategic partnerships, and physician engagement.

  8. Most Ex-U.S. Countries Can't Access The Medicines They Help Study 12/19/2025

    When a country hosts a clinical trial, we assume patients there will eventually benefit from the therapy they helped test. Research Jennifer E. Miller, Ph.D., says that's not often the case.

  9. 2 Expectations & 2 Warnings For The Year Ahead 12/19/2025

    Just when I thought I was done with 2026 predictions for the clinical trial industry, three members of my editorial board emailed me some great ones, hence, part 3 of this series. What’s interesting is that two of these submissions, coincidentally, are focused on optimism for AI. In contrast, Denise Bronner’s forecast for the coming year is much more … well, dire.

  10. More Patient Insight — And Funding— Needed To Advance Preeclampsia Research 12/18/2025

    Preeclampsia Foundation’s Laney Poye discusses the urgent need for sustained preeclampsia research funding, patient-informed trial design, and stronger partnerships between advocacy groups and biopharma.