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 high-intermediate 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 and EMA communications for vendor oversight and the necessigy for "managing the clinical trial for quality". 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.
What You Will Learn
- Historical and regulatory background for the current vendor oversight landscape
- Vendor Life Cycle Management ? Why is this needed? What is the benefit to my organization?
- What are the regulator's saying about vendor oversight?
- The application of Quality Management Systems in vendor oversight
- Vendor Governance Structures: Right-sizing for your organization
- Time for Change? Re-thinking the current paradigm for vendor RFPs – early identification of potential risks
- What are the risks with outsourcing?
- Focus on quality and risk: RFP content and selection methods for early identification of risks with vendors and their capabilities
- The role of the Project-Protocol: Quality Plan for Vendor Oversight
- Vendor Oversight: Roles, Responsibilities, Qualified Staff for Oversight Activities, and Methods
- Vendor Related Study Plans: Vendor Management Plan, Vendor Quality Management Plans, SOPs,Training and Equipping Staff for Vendor Oversight
- Metrics: Overview and utilization
Who Should Attend
This course is designed for professionals involved in clinical research, clinical operations, outsourcing, regulatory affairs, quality-compliance, and commercial-medical affairs. This course will also benefit project managers, sponsors, CROs, ACROs, AROs, NIH, DoD, and VA.
At the conclusion of this activity, participants should be able to:
- Understand the criticality of an organizational definition for “quality” that drives clinical trial and vendor oversight
- Discuss the principles, tenets and methods for Vendor Oversight
- Explain methods to manage and monitor the vendor's performance utilizing in-process monitoring assessments and methods, audits and metrics
- Describe vendor governance and management infrastructure for reference and use