Clinical Events Adjudication in the Digital Age

AUTHOR BIOS Ron Marks, Ph.D. Chief Scientific Officer, Director of Biostatistics Ron is a skilled, knowledgable biostatistician and biomedical researcher who served on the University of Florida faculty for 30 years in the Division of Biostatistics. In 2004, he retired from the university, and he now devotes his time fully to building Clinipace Worldwide and assisting in product design, trial execution and customer support. He has an extensive background in design, analysis and reporting of large-scale clinical trials and other research studies and has been a lead clinical trial consultant with a number of large pharmaceutical companies, including Unilever, Braun, Procter & Gamble and GSK. Heather Bristol, MS Vice President, Informatics As Vice President of Informatics at Clinipace Worldwide, Heather oversees the Data Management and Global Implementation Departments and drives technological advances of their proprietary software, TEMPO. Heather has been actively involved in clinical research for 18 years. She began her clinical research career running the Data Coordinating Center for the first large-scale (22,000-subject), web-based clinical trial, INVEST. She has been driving the industry to run more efficient, technology-amplified clinical research since. Heather holds a master’s in statistics from the University of Florida and a Bachelor of Science in mathematics from Sonoma State University. Manejeh Yaqub, MD CEC Consulting Expert Manejeh leveraged her experience as a medical monitor and clinical safety expert to establish the first Clinical Events Committee (CEC) at Clinipace Worldwide as well as its processes and procedures. In her role, she identified CEC and Data and Safety Monitoring Board (DSMB) members, established charters, performs training, develops and manages contracts with physicians serving on these committees and manages CEC/ DSMB budgets and payments. Manejeh participates in various CEC and DSMB meetings in addition to business development activities for related bid wins. Prior to joining Clinipace Worldwide, Manejeh served in various medical monitoring positions and other related roles in market-leading biopharma companies, including Medtronic, Abbott Vascular and Elixir Medical. 10

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