Ed Seguine is CEO of Clinical Ink, a provider of electronic source document technology. Previously he was CEO of Fast Track, General Manager of Medidata's Trial Planning products, and helped establish Eli Lilly's venture capital group. He has an MBA from Indiana University and a BS from BYU.
Dennis Marquis is a Director within the Global Quality and Regulatory Compliance organization for BMS R&D. He and his staff conduct audits of internal and external organizations for compliance with e-record and e-signature regulations for all three major areas of compliance; GLP, GMP and GCP.
Prior to joining CDER Jonathan worked at CDRH BIMO and co-developed the Software Education Program. Jonathan specializes in Computerized Systems used in FDA regulated Clinical Investigations. Jonathan holds an MS in Bioscience Reg. Affairs from Johns Hopkins & BS from UMCP in Cell Biology & Genetics
Andrew Roberts, Novartis Institutes for BioMedical Research, Switzerland
Description
Electronic medical records (EMRs) are often touted as the miraculous solution to reduce clinical trial costs in the future. This session focuses on the business model implications of using EMRs for clinical research and how that could affect whether EMRs are really the solution.
Learning Objectives: Differentiate myth from fact about EMRs for clinical research Summarize major business model implications of proposed EMR-EDC standardization efforts in language executives can understand Evaluate relevance of EMR data for specific study objectives.