Dan Schell articles
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Want To Improve Study Startup? Get More Efficient
10/3/2024
John McAdory, VP of ClinOPs at CG Oncology, recognizes that today’s clinical trial designs tend to be very complex, which complicates study startup. He says the key to improving this challenge is to find small ways to be more efficient throughout the process.
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AI Can't Help Bad ClinOps/Health Equity Data
9/25/2024
Brian Johnson, Ph.D., VP, R&D Technology at Takeda discusses the huge opportunity of connecting disparate ClinOps data and leveraging generative AI to reduce costs and labor during the clinical process.
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Key Takeaways From Clinical Trial Diversity Discussion
9/24/2024
During the Clinical Leader Live, The Diversity Mandate: Effective Strategies in Clinical Trials”, we discussed everything from the guidance, to diversity action plans, to the need for better data on race, ethnicity, and identity. In this article, we also share 25 questions audience members had regarding this hot topic.
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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.
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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.
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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?
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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.
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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.
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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.
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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.