Dan Schell articles

  1. 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.

  2. 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.

  3. 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.

  4. DCT Benefits Are Proven, Yet Progress Is Slow 7/21/2025

    Despite the clear benefits of decentralized trials—broader reach, better retention, and higher diversity—adoption has been slow. In this interview, Sunny Kumar of Informed Ventures explains how AI is lowering costs, speeding up study builds, and pushing DCTs from fringe to future.

  5. Paving The Way For Sites To Use Their Own Tech 7/17/2025

    The DTRA has released a detailed playbook to help clinical research sites use their own validated technology in sponsor-led trials. The "Bring Your Own Technology" (BYOT) model aims to reduce tech overload at sites, improve efficiency, and preserve regulatory compliance — starting with eConsent as its first use case.

  6. Clinical Trials Get A Council For AI Oversight 7/14/2025

    AI in clinical trials is moving fast — but without clear standards for ethics, transparency, or oversight. Advarra's new Council for Responsible Use of AI in Clinical Trials aims to change that. Founding members Sanofi, Recursion, and Velocity Clinical Research are stepping up to define what “responsible” really looks like.

  7. Tufts & PACT Release New DCT Analysis 7/7/2025

    We take a closer look at some of the key stats in a new DCT report from the Partnership for Advancing Clinical Trials (PACT), a consortium hosted and facilitated by the Tufts Center for the Study of Drug Development (CSDD).

  8. PI's CRAACO Model + AI = Rapid Enrollment 6/30/2025

    At Dr. David Almeida’s clinical trial site in Erie, PA, he practices the CRAACO model exclusively, relying on the revenue he makes from conducting clinical trials for eye-related diseases. To minimize his costs and speed up trial enrollment, he uses a proprietary AI system that has given him an 85% screen-to-enroll ratio.

  9. 25 Tips To Prepare A Clinical Site For FDA Inspection 6/17/2025

    During the last year I have interviewed six former FDA investigators and a regulatory expert who has been involved with more than 250 inspections. From all those interviews, I’ve culled the following list of takeaways that I hope you will find useful when preparing for any type of regulatory inspection.

  10. 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.