Course Outline

Module 1: Introduction to outsourcing

• The basics of outsourcing models and strategies
• What to outsource: selection, goals and benchmarking
• Vendor selection & management essentials to include timeframes
• Regulatory Requirements and Quality expectations
• Basics of vendor oversight and vendor management?
• Metrics to drive transparent outsourcing
• Vendor Governance

Module 2: Meeting regulatory expectations

• Examining EU and US regulatory expectations and requirements
• Exploring the evolution of vendor oversight: sponsors maintaining full accountability even with the complexity of outsourcing
• Understanding transfer of obligations rather than transfer of responsibilities
• Case studies: Examples of cases where the sponsor has failed to comply with regulation / received warning letters
• How can sponsors ensure meeting regulatory expectations?

Module 3: Selection of the right outsourcing partners

• Start with the end goal as a focus
• Selecting a partner to fit your defined strategy
• RFI, RFP
• Bid Defence
• Vendor capabilities assessment
• Site inspections
• Financial assessment and mock bids
• Cost management versus getting it right first time
• Core elements for contracts
• Quality Agreements
• Identifying, understanding and managing risk

Module 4: Vendor management: What are the key components of vendor management?

• Vendor management: What are the key components of Vendor Management?
• RACI
• Ensuring and enabling operational deliverables
• Monitoring and documentation of goals, deliverables and quality
• What is the overarching concept for vendor management?
• Operational Metrics
• Achieving effective management across multiple service providers
• Issue management and effective escalation processes

Module 5: Vendor oversight: What are the key components of vendor oversight?

• What is difference between vendor management and vendor oversight?
• What is defined as success for vendor oversight?
• Define your oversight philosophy
• Demonstrating control to inspectors
• Effective shared risk approaches to vendor oversight: ‘Skin in the game’
• Hands on/hands off – does it matter?
• Auditing strategy: Reaffirmation of vendor capabilities and CAPA management

Module 6: What is governance? Implementing an effective governance structure

• Ensuring organizational alignment to outsourcing strategy
• What is required for effective governance of vendors
• Designing a model to effectively manage and oversee multiple vendors
• Roles and responsibilities in vendor management
• Ensuring complementary relationships between QA and outsourcing
• Business continuity

Module 7: Risk Management for Clinical Outsourcing

• Risk Management for Outsourcing
• Risk Identification
• Risk Impact Mitigation through Risk Management
• Risk Management Plan

Module 8: Maintaining healthy business relationships

• Success strategies for effective communication
• The right level of transparency
• Overcoming challenges with change management
• Case studies: Differing approaches taken by vendors

Module 9: Using metrics effectively when outsourcing

• Metrics to measure your performance
• Metrics to measure vendor’s performance
• Metrics to drive transparency
• Metrics to drive trust

Module 10: High level legal and financial considerations when outsourcing

• Development of a contract
• Key documents
• Legal terms
• Typical legal issues and how to overcome them
• Financial Oversight