Advanced Clinical Vendor Oversight: Vendor Life Cycle Management

In today's complex clinical research environment with global trials, various financial models and reduced resources to execute clinical trials, sponsors hire various vendors/suppliers to meet the needs of the clinical trial/clinical program. Whether the selection of vendors is in a 'preferred provider' model or not, companies find themselves with the need to select and manage vendors in a highly scrutinized regulatory landscape for vendor oversight. As regulators state, sponsors may transfer their obligations to a vendor for specific activities related to a clinical trial, but it is the sponsor who is ultimately held accountable for the work performed on their behalf. This is a requirement for 'any size' of an organization (virtual, small, medium, large).
 
This course addresses vendor management utilizing a quality management life cycle approach that supports systematic, quality-driven oversight, such as: selection of vendors, identification of risks with a vendor 'upstream' in the process of vendor management (vs. downstream - when the trial is conducted), as well as vendor oversight and management. Referencing the FDA, FDA-CTTI and EMA initiatives influencing industry to 'build quality into the clinical trial', this course focuses on key quality principles and methods for defining, assessing and overseeing outsourced activities for quality.  

Vendor Life Cycle Management, which is well-known and utilized in other industries, will be discussed in the class for benchmarking purposes.

• Historical and regulatory background for the current vendor management landscape
• What is vendor life cycle management? Why is this needed? What is the benefit to my organization?
• What are the regulator's saying about vendor management
• The application of quality management systems in vendor management
• Vendor governance structures
• Vendor selection:  criteria, scoring tools, identification of risks
• Vendor qualification assessment/visits - partnership : QA and functional departments
• Vendor risk management plan
• Vendor management methods
• Vendor related study plans: vendor management plan, vendor quality management plans, SOPs, sponsor training plan, etc.
• Metrics utilization

At the conclusion of this activity, participants should be able to:

• Discuss the principles, tenets and methods for Vendor Life Cycle Management.
• Identify the risks of utilizing an outsourcing model
• Describe appropriate methods to assess, identify, manage and monitor the risks
• Explain methods to manage and monitor the vendor's performance utilizing in-process monitoring assessments and methods, audits and metrics.
• Identify gaps with current vendor governance and management infrastructure and the requisite solutions that address the gaps.