Dan Schell articles

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. Why More Biotechs Are Starting Trials In Australia 8/27/2025

   Why are so many U.S. biotechs heading to Australia for their first-in-human trials? Speed, cost, and simplicity. In our latest piece, Megan Robertson and Tina Soulis break down how sponsors can move from protocol to first patient in just a few months—while saving money and generating data regulators will accept worldwide.

9. Why CRO Site Network Strategies Confuse Me 8/6/2025

   As CROs evolve beyond traditional service roles, many are investing in proprietary or semi-integrated site networks to streamline trial delivery, improve patient access, and boost data consistency. This article explores how major players like ICON, Parexel, PPD, and Syneos Health are building or partnering with site networks—sometimes through direct ownership, sometimes through curated alliances.

10. When Survival Comes First, Trials Come Last 8/1/2025

    Infectious disease PI Dr. Claudia Martorell has long focused on recruiting underserved populations into clinical trials. But amid healthcare cuts, economic instability, and a retreat from DEI initiatives, she’s now watching access unravel. In this interview, Martorell shares what happens when survival takes priority over research — and why diversity in trials is once again at risk.