Dan Schell articles

  1. Easy Mistakes To Make During An FDA Inspection 7/25/2024

    As a former FDA investigator, Vincent Cafiso has heard — and seen — it all when it comes to what NOT to do during an FDA inspection. Here he gives some good advice on who you should have present in the room during an inspection and how you should interact with the investigator.

  2. Defying Industry Setbacks, MindMed Advances Psychedelic To Phase 3 7/17/2024

    Despite the psychedelics industry reeling from Lykos’ recent failed FDA hearing, MindMed is riding high after a positive End-of-Phase 2 (EOP2) meeting with the regulator that has set up the small biopharma for a Phase 3 trial of its LSD-based treatment for generalized anxiety disorder (GAD). 

  3. A Look At 5 Years Of CRO Leadership Awards 7/9/2024

    Are the same companies winning the CRO Leadership Awards year over year? I decided to look back at the data to find out. 

  4. Insights Into TMF Challenges & Solutions — Part 2 6/28/2024

    In part 2 of this two-part Q&A, Nicole Palmer, CEO and president of consulting firm Granular Level, gives some good career advice for TMF professionals and talks about TMF audits and the EU’s Clinical Trials Information System (CTIS).

  5. 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. 

  6. 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.

  7. 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.

  8. 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. 

  9. 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.

  10. 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.