Dan Schell articles

1. Why Feasibility Still Feels Broken 11/24/2025

   During an interview with Dresden Whitehead of Avacare Clinical Research Network, her take on feasibility mirrored concerns raised during a 2024 Clinical Leader Live (CLL) webinar. She highlighted repetitive questionnaires, unclear sponsor expectations, and the challenges new investigators face. Combined with insights from the CLL discussion, the article explains why feasibility remains a persistent industry pain point.

2. Site Payments Are Still a Mess, But Takeda Is Trying To Help 11/19/2025

   In this article, Heidi Barham, Takeda’s associate director of clinical study site payments, explains how the company is replacing opaque CRO-driven processes with real-time transparency, streamlined startup payments, and a dedicated sponsor-side team that sites can actually reach.

3. Turning Site-Centric From Slogan To Reality 11/12/2025

   SCRS’s Collaborate Forward initiative aims to move “site-centricity” from industry buzzword to operational reality. By documenting how sponsors, CROs, and technology providers are improving feasibility, budgeting, contracting, and patient recruitment through measurable collaboration practices, SCRS is working to provide the industry with a playbook for better site relationships and trial execution.

4. Two Former FDA Chiefs, Two Very Different Warnings 11/6/2025

   Former FDA Commissioners Scott Gottlieb and Robert Califf are sounding alarms from opposite ends of the industry. Gottlieb warns that a leaner, under-resourced FDA will make life harder for clinical operations, while Califf argues the deeper failure lies in a healthcare system that’s forgotten how to learn from itself. Together, they paint a sobering picture of what’s really broken in clinical research — and why fixing it will take more than new guidance.

5. 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.

6. FDA Vs. MHRA Vs. EMA: Differences In 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.

7. 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.

8. 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.

9. 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.

10. 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.