Dan Schell articles

31. Are You Afraid Of Adopting New Outsourcing Models? 8/21/2024

    Pricing strategies for outsourcing clinical services have evolved over the years, yet many sponsors are reluctant to change from their status quo. That may change, though, as CROs begin to add technology and site networks to their offerings. 

32. Why We Need Technology Consolidation In Clinical Trials 8/16/2024

    As more and more trial designs incorporate technologies that generate an immense amount of data, data managers struggle to continuously interconnect disparate systems and standardize data. All of this fuels the need for technology consolidation.

33. Government Contract Advances Walgreens In Clinical Space 8/1/2024

    Walgreen’s new $25 million deal with BARDA (Biomedical Advanced Research and Development Authority) is a huge win for the pharmacy chain. John Campbell, head of DCTs at Walgreens, explains the ins and outs of the study and what could be next for the company regarding its clinical trials division.

34. 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.

35. 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). 

36. 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. 

37. 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).

38. 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. 

39. 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.

40. 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.