Dan Schell articles

1. Funding Diversity Where It Starts — At the Site 11/3/2025

   After crossing paths with retired family physician and researcher Dr. Bryce Palchick at two conferences, I learned about ACRO’s new Diversity & Inclusion Site Resource Grants Program — an effort funding community sites like Bryce’s to make trial diversity more than a buzzword by supporting real, grassroots engagement.

2. How The FDA, MHRA, & EMA Differ On Externally Controlled Trials 10/23/2025

   As the FDA, MHRA, and EMA release draft frameworks on externally controlled trials, sponsors face differing expectations. The U.K. leans pragmatic, the U.S. remains cautious, and Europe’s guidance is still evolving — leaving global trial planners to navigate regulatory gray zones.

3. Clinical Trials At A Crossroads 10/22/2025

   At DPHARM 2025, McKinsey’s Gaurav Agrawal warned that while clinical science is accelerating, trial operations aren’t keeping pace. He outlined a vision for 2035 built on scaling AI, expanding site ecosystems, and bringing trials closer to everyday patient care.

4. Inside A Micro-CRO's Evolution 10/17/2025

   A new generation of micro-CROs is emerging—lean, virtual, and built by experienced ClinOps leaders. Instead of owning infrastructure, they’re renting it, showing that credibility and connections can rival size in today’s contract research market.

5. A New Site With An Old Truth: Access Is Everything 10/8/2025

   Just two months after launching RASAI Research in Jackson Heights, NY, Dr. Ammara Mushtaq is proving that clinical trials work best when they’re built into the fabric of the community — and when we stop losing “one-and-done” physician investigators.

6. My Unexpected Takeaways From The SCRS Conference 10/3/2025

   Some people complain about the cost of conferences compared to what they get out of them. A common complaint is these events are just full of the same people and the same problems are being discussed with no real solutions. I’d argue, though, that not all conferences — at least not SCRS 2025 — are created equal.

7. RWE Is Growing Up, And Here's Why That Matters 9/29/2025

   Real-world evidence is shifting from the margins to the mainstream of drug development, but data quality, trust, and regulatory clarity remain hurdles. ISPOR is helping set the standards to guide its future.

8. Seriously … Are We Making Any Progress? 9/25/2025

   Ken Getz’s DPHARM talk revealed how ballooning data collection in trial protocols drives costs, delays, and site burden. New ICH E6 R3 guidance pushes for simpler, more flexible designs, but real progress will require collaboration — and restraint.

9. Gottlieb Warns Leaner FDA Will Challenge ClinOps 9/19/2025

   Former FDA commissioner Scott Gottlieb told DPHARM attendees the agency is strained by staff losses and slowing policy work—leaving ClinOps teams facing tougher reviews, longer waits, and more uncertainty ahead.

10. The Dream Is EHR-To-EDC — eSource Is The Wake-Up Call 9/11/2025

    EHR-to-EDC integration promises efficiency but struggles with interoperability, compliance, and site adoption. eSource emerges as the real bridge, with case studies like MSK proving it can cut setup times, boost accuracy, and lighten site workload.