Dan Schell articles

  1. Site Networks Find Strength In Numbers With AMRC 1/29/2025

    Jim Kremidas, executive director of the newly launched Association of Multisite Research Corporations (AMRC), talks about the genesis and future of this association, which launched with 14 multisite clinical research corporations (MCRCs) members.

  2. We're Looking At Patient Recruitment All Wrong 1/22/2025

    Leanne Woehlke, a 30-year veteran of the clinical research industry, says our standard patient recruitment efforts are lacking one key element — a focus on the patient’s needs. 

  3. Should You Choose An FSP Model? It Depends… 1/10/2025

    Small biotechs are often drawn to an FSP model because they believe it’s a less expensive option as compared to an FSO. But that’s not always the case, says Réne Stephens of Danforth Advisors, who gives some examples of what to consider before making your choice of outsourcing solution.

  4. Should We Be Scared Of PE Firms Investing In Sites? 12/16/2024

    It seems lately there's been a lot of vilification of private equity (PE) firms that are purchasing site networks. I'm sure this sentiment has increased during the past few years, but is it justified? 

  5. Let's Fix The Tax Burden On Clinical Trial Participants 12/10/2024

    We all know that patient retention is lowered once a participant realizes the tax implications of being in a clinical trial. But taxes should be the last thing they have to worry about, so why can’t we get some changes made? 

  6. Were There Any Surprises In Clinical Trials In 2024? 12/4/2024

    Is it any surprise that when I asked a group of clinical trial industry experts to summarize some of the things that stood out to them in 2024, that AI would be mentioned more than once? Probably not. Resistance to DCTs, increasing regulatory scrutiny, and a slowdown in CRO M&As also made their lists — but I’m guessing none of that surprises you, either.

  7. 2024: Familiar Problems & Encouraging Progress 11/27/2024

    For part 1 of my 2024 recap, I asked various industry experts what stood out to them this year regarding the clinical trials industry. They mentioned significant challenges related to site capacity, enrollment, workforce changes, and trial complexity, but they also seemed encouraged with some of the efforts and emerging solutions that will address these issues.

  8. Can Better Data Management Save Clinical Trials? 11/25/2024

    In this summary of our 10/31/24 Clinical Leader Live, we talk about the current ICH M11 guideline, which focuses on a clinical electronic harmonized protocol, as well as the need for data standardization and the benefits of the resulting automation. Our panelists include Jessica Jolly, a data science expert with 25 years of experience, and Hassan Kahlid, senior engineer, machine learning and data science at AstraZeneca.

  9. PI Insights From A Heart Failure Trial: Part 2 11/19/2024

    This is part 2 of Dan Schell’s interview with Jennifer Cowger, MD, the co-principal investigator of the Abbott TEAM-HF clinical trial. Here, she elaborates more on some of her tasks specific to this heart failure trial. 

  10. PI Insights From A Heart Failure Trial: Part 1 11/14/2024

    Jennifer Cowger, MD, the co-principal investigator of the Abbott TEAM-HF clinical trial, talks about her role as a PI including trial design and meetings with the FDA.