James Riddle, MCSE, CIP, CPIA, CRQM

SVP, Global Review Services, Advarra

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

Blog

Why IRBs Ask for Certified Translations of Informed Consent Forms: Regulation, Guidance, and Practical Reality 

Understanding the regulatory foundation behind translated informed consent documents and why many institutional review boards (IRBs) require...

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Blog

How Integrated IRB and IBC Administration Facilitate a New Era of Interventional Genetic Therapeutics 

Gene therapies and gene-based therapeutics are giving way to a new era of interventional genetics. Integrated ethics review and...

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Blog

Do DSMBs Need AI Expertise?

Rethinking oversight as clinical trials become more data-driven and algorithm-informed  As artificial intelligence (AI) becomes...

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Typing, medical research and man with laptop, scientist and info for biotechnology, website and lab. Healthcare, researcher and person with tech for clinical data, analysis and study for science.
Blog

Data Safety Monitoring Boards (DSMBs) in the Era of AI and Adaptive Clinical Trials

Balancing innovation, statistical rigor, and independent oversight in increasingly complex clinical trials  Clinical trials are...

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Blog

Does mRNA Require IBC Review? How the NIH Guidelines Apply to Clinical Trials

Let me start with a question I get more and more frequently from research sites...

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A digital interface showing a person interacting with transparent virtual icons related to compliance, such as "Policies," "Regulations," "Audit," "Guideline," "Requirement," and "Law." The word "COMPLIANCE" is prominently displayed in the center, surrounded by hexagonal icons representing various regulatory and legal concepts.
Blog

The Impact of ICH E6(R3) on U.S. and Canadian IRBs

Now that FDA has published the ICH E6(R3) Good Clinical Practice (GCP) guidance, aligning early...

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Blog

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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Blog

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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Blog

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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Blog

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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Blog

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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Blog

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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