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

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...

Read More...

DMC vs EAC: What’s the Difference?

Clinical research oversight relies on both DMCs for big-picture data review and EACs for detailed...

Read More...

Planned Emergency Research and Exception from Informed Consent

Explore the regulatory criteria and ethical considerations for planned emergency research, including exceptions from informed...

Read More...

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...

Read More...

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...

Read More...

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...

Read More...

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...

Read More...

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...

Read More...

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...

Read More...

Beyond the Regulations: More Considerations for Emergency Research

In this blog post we go beyond the regulatory requirements and examine three other key...

Read More...

A Tale of Two Sites: The Power of Integrated Research Administration

Site timelines for studies can vary widely across the industry due to differences in internal...

Read More...
Scroll to Top