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Optimizing Study Monitoring Performance and Efficiency
Program Code:
374
Date:
Wednesday, June 27, 2012
Time:
3:30 PM to 5:00 PM
EST
CHAIR
:
Ken is the chairman of CISCRP and a Senior Research Fellow, Assistant Professor, at Tufts CSDD. He is a well-known speaker and author, serving on several editorial boards including the Drug Information Journal. Ken holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern U.
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PRESENTER
(S):
Ken is the chairman of CISCRP and a Senior Research Fellow, Assistant Professor, at Tufts CSDD. He is a well-known speaker and author, serving on several editorial boards including the Drug Information Journal. Ken holds an MBA from the J.L. Kellogg Graduate School of Management at Northwestern U.
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Lisa Rhiner,
Clinical Study Lead, PharmaNet/i3 Strategic Resourcing
Lisa Rhiner is a Clinical Study Lead for PharmaNet/i3 Strategic Resourcing. She has over 20 years in the industry working across therapeutic areas and phases of development, with emphasis on utilization and process improvement. She earned a BS in Clinical Research Admin from GWU.
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Michael Brennan,
Johnson & Johnson Pharmaceutical Research & Development, LLC, United States
Dr. Brennan has been in the pharmaceutical industry for over 20 years. He is a Director of Informatics. He was the the business owner for a cross-company regulatory information system that is being developed within J&J. Prior to this role, Michael was VP of Global Regulatory Operations at Centocor.
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Description
The global CRA workforce plays a vital role in assessing clinical trial compliance, maintaining relationships with investigative sites, monitoring patient safety and ensuring data quality. During the past decade, study monitor workload has increased and utilization has changed dramatically, with wide variability by geographic region. This symposium explores key characteristics, responsibilities and capacity of the global CRA workforce, notes trends impacting study monitor performance, and explores practices and solutions designed to improve CRA capacity, efficiency and effectiveness.
Learning Objectives:
Review baseline metrics characterizing global CRA workforce workload and utilization
Identify workforce trends and key management issues
Describe monitoring practices that can reduce cycle time, lower work burden and impact efficiency Discuss the impact of data standards on enabling 'real-time' data review.