
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

Ways to Streamline Informed Consent Process in Clinical Trial Startup
At a busy research site, a clinical trial is ready to launch — but it’s...
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Understanding the Impact of the New EU Artificial Intelligence Act on Clinical Research
Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention....
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The Value of Continuity: Program-level Data Safety Monitoring Boards
In the realm of pharmaceutical development, ensuring the safety and efficacy of new treatments is...
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Understanding FDA’s 2024 Draft Guidance on DMCs
The FDA's 2024 draft guidance emphasizes the critical role of independent DMCs in clinical trials,...
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DSMB Best Practices and Behind the Scenes Insights
Ensure your DSMB meets regulatory standards. Learn best practices in administration, member selection, and overcoming...
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What is a Data Monitoring Committee?
DMCs play a vital role in clinical trials by independently reviewing interim data for safety...
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Improving Study Activation Time for Gene Therapy Research
This blog explores how research sites are focusing on their institutional biosafety committee (IBC) programs...
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Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials
How do you know your experimental therapy is working? Sometimes, it can be as simple...
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Privacy Regulations Impact on Global Clinical Trial Endpoint Adjudication
New privacy regulations seem to form every few months, especially with individual U.S. states adopting...
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Unpacking IRB Innovations for Decentralized Clinical Trials
In the blink of an eye, the world has gone digital. So many tasks which...
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