Dan Schell articles

51. Insights Into TMF Challenges & Solutions — Part 1 6/26/2024

    This is part one of a two-part Q&A I did with Nicole Palmer about a variety of issues surrounding the trial master file (TMF). In this part, she talks about the TMF Reference Model, moving to an eISF, and challenges with e-signatures. 

52. Siteless DCTs Are Real … And Happening Now 6/20/2024

    Siteless DCTs (decentralized trials) are rare, but Praxis Precision Medicines is running one now for patients with essential tremor (ET). Marcio Souza, PharmD, the company’s president and CEO, talks about why they chose this model and the surprising speed at which it is progressing.

53. A Couple's Plan To Revamp Poland's Clinical Trial System 6/11/2024

    Hanna and Artur Preus collected and analyzed 3,208 questionnaires from patients, pharma companies, CROs, site staff, and private companies to identify the shortcomings in the Polish clinical trials system and then make recommendations on how to improve it.

54. 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. 

55. 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.

56. 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.

57. 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.

58. 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.

59. 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. 

60. 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.