Dan Schell articles

  1. How DIA Continues To Enhance Its Global Annual Meeting 6/3/2024

    After his first year at the helm of DIA, president and CEO, Marwan Fathallah, talks about some of the key changes and highlights at this year’s global annual meeting. 

  2. Clinical Outsourcing Observations And Predictions 5/22/2024

    Industry expert Samir Shah talks about why the FSP model is so popular these days and how site networks could become a replacement for CROs in some situations. He also suggests a new type of contracting model that could save sponsors and sites money.

  3. Competitors Need To Collaborate On Digital Biomarkers 5/15/2024

    Regeneron’s second annual Digital Biomarkers Summit is a good example of how competing pharma companies can work together in a noncompetitive environment for the industrywide goal of advancing the use of digital biomarkers in clinical trials.

  4. For Hybrid Trials, Have Some Faith … In Sites 5/9/2024

    Noelle Gaskill believes the key to regulatory success with a DCT is to not force a bunch of tech onto sites, but instead, choose those that already have the needed technology and experience and then let them do what they do best – execute on the trial.

  5. What To Expect From An FDA Inspection 4/26/2024

    Former FDA inspector turned regulatory consultant, Patrick Stone, gives some valuable insights to what to expect when the FDA comes knocking at your clinical trial site. Here's a hint: make sure you PI knows the difference between presiding over and overseeing a study.

  6. Why Can't We Compare Site Performance Measures? 4/22/2024

    Cerdi Beltré believes it’s possible to develop a global and objective way to measure investigator site performance for metrics such as startup duration, screen-pass rates, or rate of enrollment. It just won’t be easy … or make some sites happy. 

  7. Ignoring Digital Biomarkers Will Be Your Undoing 4/12/2024

    We are still in the early days of uncovering all the advantages of digital biomarkers. “It’s difficult to figure out what you can measure repeatedly and with some sense of validity,” says Bari Kowal, SVP, development operations, portfolio management & biostatistics data management at Regeneron.

  8. 4 Questions About A Digital Therapeutic Clinical Trial 4/8/2024

    Tim Peters-Strickland, SVP, clinical development & medical affairs at Click Therapeutics, explains some of the details that went into the recently FDA-approved Rejoyn digital therapeutic, which was a joint collaboration between Otsuka and Click.

  9. Dear Data Analysts, AI Is Not Replacing You 4/2/2024

    Deep beneath the ongoing narrative of AI’s potential use cases in clinical trials is the same fear that persists in other industries facing a technology revolution. Will jobs be lost and replaced by machines? So, I thought I’d ask an expert — a machine.

  10. Why Jane Myles Believes DCTs Are "Completely Doable" 3/27/2024

    If you want to know about how perceptions regarding DCTs are changing, talk with Jane Myles of the DTRA (Decentralized Trials & Research Alliance). As Program Director at DTRA, she is acutely aware of all the challenges and opportunities surrounding anything with the term “decentralized trial.”