Winning Strategies for Achieving a Quality EDC Clinical Trial Process

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Leonard A. Grunbaum, MBA – Program Committee Member

Session Description

According to Health Industry Insights, 2007 will be the watershed year for industry’s move to broad scale use of electronic data capture (EDC) in clinical trials. The FDA has also recognized the move to EDC with a new guidance on computerized systems used in clinical investigations. This workshop will provide sponsors, CROs, investigational sites, IRB members, and EDC and electronic health records (EHRs) vendors the opportunity to discuss and propose process changes, assessment/audit methods, and delivery practices for assuring the quality of electronically captured data across the whole chain of clinical trial activities.

• DIA Outsourcing Summit
• Publication Writing and Building Partnerships
• PMI Pharmaceutical SIG/DIAPMSIAC Joint Conference:
• The Future of Pharmaceutical Project Management – Is a Paradigm Shift Needed?
• Clinical Trial

Featured Sessions

• FDA’s new guidance for computer systems used by investigators in clinical trials
• Practical guidance on EDC necessities versus expectations by auditors/inspectors
• EDC as the “glue” across the clinical trial production process from protocol development to eCTD submissions € Future of EDC (validation, CDISC, data cleaning)
• HL7 and Euro-Rec certification of source systems
• Ways to use EDC for quality monitoring and auditing (data mining for quality)
• Special Town Hall Session: Industry standards and issues of compliance with EDC