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James Riddle, MCSE, CIP, CPIA, CRQM
With 25+ years’ experience providing support to the clinical research community, James Riddle helps sponsors, CROs, and research sites advance clinical research with a mission to improve human health. His expertise includes developing and operationalizing processes for maximum efficiency, client satisfaction, and participant protection; development and implementation of technology solutions; and efficient, compliant operation of large clinical research review programs. Prior to Advarra, Riddle held leadership roles at two major central IRBs and served as a senior leader within the research oversight office at the Fred Hutchinson Cancer Research Center. He is also a member of CTTI, NWABR, SASI, and PRIM&R.
Latest Posts by James Riddle
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Why Device, Diagnostic, and Digital Therapeutic Research Needs Endpoint Adjudication
In its March 2006 guidance, Establishment and Operations of Clinical Trial Data Monitoring Committees, the...
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DMC vs EAC: What’s the Difference?
Clinical research oversight relies on both DMCs for big-picture data review and EACs for detailed...
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Planned Emergency Research and Exception from Informed Consent
Explore the regulatory criteria and ethical considerations for planned emergency research, including exceptions from informed...
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James Riddle and Willie Muehlhausen Discuss Digital Technology and Virtual Data Collection in Clinical Research
About the Advarra In Conversations With… The future of healthcare innovation hinges on research and...
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Reflections from Cell and Gene Meeting on the Mesa 2021
I recently had the privilege of both presenting at and attending the 2021 Alliance for...
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Cell & Gene Therapy vs Drug Research: What’s the Difference?
Cell and gene therapy’s popularity has grown exponentially in the past year. However, it's important...
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How Sites Can Win in the New Age of Genetically Engineered Treatments
With gene therapy trials on the rise, sites must prepare biosafety protocols, facility standards, and...
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Q&A – Regulatory Fine Points: Exploring 21 CFR Part 11 Validation
In a recent webinar, James Riddle, Shannon Roznoski, and Stuart Cotter of Advarra presented Regulatory Fine...
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Is GDPR Coming to the US? CCPA and Its Impact on Research
Remember on the older The Price Is Right game shows with Bob Barker, when the...
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