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Session 6: Logistical and Operational Benefits and Challenges of an Audit Method
Session Chair(s)
Annette Schmid, PhD
Senior Director Scientific & Medical Services, Head of Oncology Imaging Strategy, PAREXEL International, United States
This session critically evaluates the advantages, limitations and practical implications of implementing an audit method in oncology clinical trials. What does this mean with respect to the predictability and reliability of the process? How might it impact the management of timelines, quality and risk, and the success of a regulatory submission? What steps should be put in place in advance of any reads? Are there implications for patients? Perspectives from the pharma sponsor, core laboratory industry, and the site clinical trial reader will be presented.
Speaker(s)
Robert Ford, MD
Founder and Principal, Clinical Trials Imaging Consulting, LLC, United States
An iCRO Perspective
S. Peter Eggleton, FFPM
Medical Director, GCDC Oncology, Merck Kgaa, Germany
An Industry Sponsor Perspective
Ira Smalberg, MD
Radiologist, Tower Saint John's Imaging, United States
A Site Reader Perspective
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