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overview
It is essential for industry to employ efficient and accurate strategies for monitoring outsourced clinical trials to minimise the chances of receiving warning letters from competent authorities. Companies should have robust structures in place for successful vendor selection, contract design, quality monitoring and risk minimisation when outsourcing clinical trials to remain compliant.
Using a combination of theory and practical examples, this essential 10-module course will provide a crucial overview of your responsibilities as a sponsor, giving you the knowledge, you need to ensure quality oversight over 5 weeks.
What Will You Learn?
- Introduction to the complexities of vendor selection, management and oversight
- Review of different outsourcing strategies and models
- Different outsourcing models from strategy, through vendor selection and effective implementation
- Comprehend your responsibilities as the sponsor both from GCP perspective and from vendor management perspective
- Identify the right level of management and oversight
- Understand the outsourcing strategies for selecting, monitoring and communicating with your service providers
Who Should Attend?
All professionals who are involved in vendor oversight will benefit from this course, including:
- Clinical Outsourcing
- Contracts and Outsourcing
- Clinical Quality Assurance
- Clinical Quality Control
- Clinical Operations
- Vendor Management
- Global QA/Compliance
- Regulatory Affairs
Benefits of an Online Academy Course
- Learn and apply – implement what you learn during the course
- Become part of a professional learning community – discuss any problems with students and/or the trainer
- Time effective – bitesize chunks so it does not impact on your normal working day
- Cost effective – no travel expenses
- Grow as a team – with multiple licenses your team can access the course and learn together, no matter where they are in the world
Online Academy Video
Agenda
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
On-site & in-house training
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