Dan Schell articles
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2026 Forecasts From People Smarter Than Me – Part 1
12/12/2025
In Part 1 of this forecast series, leaders from TransCelerate, Genentech, Clinical Performance Partners, Marketcap Consulting, and others weigh in on what’s coming next — from regulatory pressure and RBQM mandates to BYOT momentum, AI reality checks, and the financial rebound many CROs are betting on.
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Why HEOR Keeps Arriving Too Late — And How ClinOps Can Fix It
12/9/2025
Rob Abbott, CEO of ISPOR, breaks down why HEOR timing keeps clashing with ClinOps timelines and offers practical ways to integrate value, evidence, and payer expectations much earlier in development.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.