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A Systematic Approach to Study Start-Up
Session Chair(s)
Marina Alexandra Malikova, PhD, MBA, MS, RAC
Executive Director, Translational Research, Assistant Professor of Surgery
Boston University School of Medicine, United States
Systematic assessment of risk factors and key performance indicators at a start-up phase can allow for more efficient execution of a clinical trial and ensure better accrual rates. This session will discuss best practices to expedite start-up phase.
Learning Objective : Develop a sound business strategy for a more efficient study start-up; Determine key performance indicators and risk factors contributing to the delays at the start-up phase; Implement mitigation strategy in order to avoid delays and allow for successful launch of a clinical trial.
Speaker(s)
IRB Performance Metrics: Data From 105 Institutions Defining the Current State and Implications for Clinical Trials
Stuart Horowitz, PhD, MBA
WCG IRB, United States
President, Institutions & Institutional Services
A Systematic Approach to Study Start-Up: Applying Quality Risk Management to Clinical Studies
Marc Jason DeLuca, MS
InVentiv Health Clinical, United States
Associate Director, QRM Group
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