NEW - Clinical Sponsor Oversight

Summary

In clinical research, many organisations increasingly rely on external service providers, including Contract Research Organisations (CROs), laboratories, Electronic Clinical Outcome Assessment (eCOA) vendors, imaging vendors, and decentralised technology providers.

As the sponsor, you retain overall responsibility, which places greater demands on your oversight practices.

Through concrete examples and practical methods, this course will give you tools to:

• Understand regulatory expectations for sponsor oversight in outsourced clinical trials and translate them into practical actions
• Clarify how much or how little sponsor oversight is required
• Ensure that service providers deliver in accordance with your standards and regulatory requirements
• Document oversight activities to the right standard

This course helps you understand, structure, and strengthen your oversight practices, giving you better control over outsourced work and helping you safeguard participant safety, data integrity, and compliance.

In addition, you will gain practical tools and ideas for how to ensure the right level of oversight.

This course is interactive through concrete examples and practical methods. You will gain tools to develop an oversight plan and to document oversight activities, ensuring appropriate quality and compliance in clinical trials.

 

Keywords

• Sponsor oversight
• Clinical research organisation (CRO)
• Outsourcing
• Regulatory expectations
• Inspection readiness