Focus on the importance of a risk-based approach to
sponsor oversight.
Risk Identification and Assessment: Discuss methods for identifying potential risks early in the trial lifecycle.
Developing Risk Mitigation Strategies: Explain how sponsors can implement plans to minimize the likelihood and impact of identified risks.
Risk Monitoring and Adaptation: Highlight the need for ongoing monitoring of risks and adapting mitigation strategies as needed.
The Role of Oversight in Risk Management: Emphasize how effective oversight is integral to proactive risk management.
Conclusion: Argue that a proactive, risk-based approach to sponsor oversight is essential for preventing issues and ensuring trial success.