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James Riddle, MCSE, CIP, CPIA, CRQM

VP of Research Services & Strategic Consulting, Advarra

Prior to joining Advarra, James Riddle served as a leader of the human subject protection and animal care and use program at the Fred Hutchinson Cancer Research Center, one of the nation’s largest independent cancer research centers. In addition, he was an Association for the Accreditation of Human Research Protection Programs (AAHRPP) site visitor and was the vice president of operations and director of technology at another large central IRB. Riddle is also a faculty member, mentor, and regular speaker for Public Responsibility in Medicine and Research (PRIM&R); a member of the Clinical Trials Transformation Initiative (CTTI) Steering Committee; a board member of the Northwest Association for Biomedical Research (NWABR); and a leader of the Alliance for Clinical Research Excellence and Safety (ACRES) Site Accreditation & Standards Initiative (SASI) technology domain accreditation team.

James Riddle

Latest Posts by James

 
Blog

What is a Data Monitoring Committee?

In a complex clinical trial, data monitoring committees oversee interim data to ensure adequate safety monitoring.

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6 min. read
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Blog

Multiple Dynamic Endpoints and the Role of Endpoint Adjudication Committees in Clinical Trials

Trial designs incorporating multiple endpoints to support efficacy are receiving increased focus from the FDA, including a recently published guidance.

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6 min. read
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Blog

Privacy Regulations Impact on Global Clinical Trial Endpoint Adjudication

Endpoint adjudication committees must keep up with rapidly developing requirements as they receive potentially identifiable research data.

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5 min. read
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Blog

Unpacking IRB Innovations for Decentralized Clinical Trials

Ethical oversight committees continue to innovate to keep pace with the rapid changes and evolution of research conduct.

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6 min. read
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Blog

What Goes into a Charter for DSMB or Endpoint Adjudication?

This blog outlines the key elements of a DMC/EAC charter document, explaining its importance in conducting safe and compliant research.

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5 min. read
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Blog

Clinical Endpoint Adjudication Committees: Not Just for “Endpoints”

This blog outlines critical events where EACs are used to look at more than just “endpoints” in clinical research.

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4 min. read
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Blog

A Look at the Processes Behind Clinical Endpoint and Event Adjudication

Take a closer look at how and why we leverage proprietary, custom, and intelligent technology in our EAC program

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7 min. read
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Blog

Why Device, Diagnostic, and Digital Therapeutic Research Needs Endpoint Adjudication

This blog outlines when a device clinical trial sponsor should engage an EAC or CEC to provide specific medical expertise & safety oversight.

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5 min. read
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Blog

DMC vs EAC: What’s the Difference?

This blog outlines the requirements for each committee, what it does, and the critical roles each plays in keeping research participants safe.

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5 min. read
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White Paper

Planned Emergency Research and Exception from Informed Consent

This white paper outlines considerations for those involved in planning, designing, conducting or reviewing EFIC studies

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Podcast

Trend Forecasting: What Does 2022 Have In Store for Clinical Research?

What will be the 2022 trends in clinical research? In this episode, we forecast what is coming up for clinical trials.

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Podcast

James Riddle and Willie Muehlhausen Discuss Digital Technology and Virtual Data Collection in Clinical Research

In this episode, we discuss the growth of decentralized clinical trial technology and how IRBs evolved to account for technology advancements.

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