Dan Schell articles

  1. Insights From 250+ Regulatory Inspections 6/10/2025

    Elisabeth George, who has led more than 250 FDA inspections, shares practical advice for hosting audits — including preparation tips, team coordination, live documentation, and knowing exactly when to speak.

  2. Why Perfect Clinical Trial Data Is A Dangerous Myth 6/2/2025

    Former FDA inspector Kara Harrison reveals clinical trials fail due to overcomplex designs, checklist-driven monitoring that misses critical issues, and lack of focus on what actually matters for patient safety and data integrity.

  3. Here's Your 483 — And Your Hug 5/27/2025

    Former FDA inspector Tracey Harris shares what clinical sites get right, what they botch completely, and why inspection readiness is about more than coffee, binders, or bluffing.

  4. Spiders, Mold, & SOPs: Tales From A Site Inspection Veteran 5/22/2025

    Sarah Moeller, a veteran of mock regulatory inspections, shares lessons from over 300 site visits, emphasizing preparation, documentation, and patient-focused practices to ensure sites are inspection-ready.

  5. U.K. Has Strong Plan To Reform Clinical Trials 5/8/2025

    The U.K.’s 2025 clinical trial reforms aim to boost research efficiency, inclusivity, and global competitiveness by streamlining approvals, enhancing patient involvement, and addressing structural, demographic, and therapeutic gaps in trial activity.

  6. Local HCPs In DCTs: A Game-Changer For Oncology Trials 4/29/2025

    An AMC’s decentralized trial model uses local HCPs to expand oncology research access across North Carolina while maintaining regulatory compliance and building on early DCT experiences and FDA collaboration.

  7. 7 Steps To Manage Local HCPs In A Decentralized Trial 4/17/2025

    Here’s a template you can use for a multi-step process to create a centralized system to verify the credentials, licenses, and professional standing of all local healthcare professionals (HCPs) participating in a DCT.

  8. Local HCPs in DCTs: Big Benefits, Bigger Burdens? 4/17/2025

    Local HCPs in DCTs provide benefits like improved patient accessibility, retention, and diversity, but create significant oversight burdens for investigators and sponsors, requiring extensive documentation, training protocols, and communication systems to maintain compliance.

  9. The Evolution Of A Clinical Research Coordinator 4/9/2025

    Briana White is a CRC with Superior Clinical Research, a small clinical research site in Smithfield NC. She talks about how she got into the clinical industry and what she struggles with in her job (spoiler alert: it involves tech). 

  10. Being Financially Prudent As A Site Isn't a Bad Thing 4/1/2025

    Most sites are composed of three silos of people who rarely cross communicate -- especially about issues that could affect finances. But if your job is to take care of patients. should you be concerned about the same things as your finance-related colleagues? Dr. Daniel Fox says, at the very least, you should be communicating some key events/milestones.