Dan Schell articles

41. We Need More Clinical Trial Awareness … Oh, And CRCs 9/19/2024

    Christina Brennan, SVP for the clinical research program at Northwell Health, talks about how increasing the awareness of clinical trials can lead to better patient-centricity and why we need to start positioning clinical research as a career. 

42. Not What I Expected From A Vendor Conference 9/12/2024

    Dan Schell recounts some of his key takeaways after attending the Veeva R&D Quality Summit in Boston in September 2024. Some of the topics discussed include DCTs, eCOA, and the need to simplify tech integration at sites. 

43. FDA Under Pressure To Respond To China-Related Clinical Trials Questions 8/27/2024

    The FDA has until October 1, 2024 to respond to a number of questions regarding concerns about clinical trials being conducted in The People's Republic of China. How will their answers affect trials going forward and the sponsors that were conducting those China-based trials?

44. 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. 

45. 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.

46. 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.

47. 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.

48. 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). 

49. 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. 

50. 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).