#41: Quality Oversight of CROs - Clinical Vendors

Tutorial name:
#41: Quality Oversight of CROs - Clinical Vendors

Day & Time:
June 24, 9:00AM - 5:00PM

Room Number:

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FDA and EMA communicate at industry conferences, FDA-CTTI meetings, and regulatory agency public meetings. Sponsors and CRO-vendors who are transferred the responsibilities for trial conduct must have in place a vendor management-oversight program and methods, as well as a quality management system and risk management framework for the execution of clinical trials. Building upon this framework and benchmarking to ISO-9001: 2008, Quality Management Systems, this tutorial describes Quality Oversight of Vendors, with the focus on quality systems, quality attributes, and performance monitoring.

Learning Objective(s):
At the conclusion of this tutorial, participants should be able to:

• Discuss quality management systems principles and methods in the context of clinical program management and vendor oversight.

• Identify two (2) key elements of an internal communication plan for vendor oversight that supports both business and team successes.

• Identify two (2) metrics for utilization when outsourcing a clinical trial to a vendor.

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