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#41: Quality Oversight of CROs-Clinical Vendors

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

Day & Time:
June 14, 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 management systems, risks associated with outsourcing and approaches for early identification of risks to support adequate oversight, 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, and the criticality for early risk identification with a CRO clinical vendor in order to execute adequate vendor oversight;
• Identify two key elements of an internal communication plan for vendor oversight that supports both business and team successes;
• Identify two metrics for utilization when outsourcing a clinical trial to a vendor.

Target Audience:
This tutorial is designed for professionals involved in clinical research, clinical operations, outsourcing, regulatory affairs, quality compliance, project management and commercial-medical affairs. Sponsors, CROs, ACROs, AROs, as well as personnel from the NIH, DoD, and VA will also find this tutorial valuable.