Sponsors and CROs are under increasing pressure to monitor and manage risk from various perspectives and under multiple FDA guidances. Complying with regulations such as ICH E6(R2), while meeting milestones and addressing issues, is time-consuming and costly.
This webinar dives into best practices for the identification and ongoing management of risk during the clinical trial process. We also present a case study of a leading pharmaceutical company that faced multiple challenges affecting its risk profile.
Examine best practices—including how to define, analyze, and operationalize the risk management process in the study conduct phase—that you can use to answer important questions, such as:
- “How can I identify and mitigate risk earlier?”
- “How can we put lessons learned into our risk mitigation plans moving forward?”
- “What metrics and/or processes can be used to help resolve risks that are identified?”
- “How can team members from the CRO, sponsor, and other vendors collaborate more effectively to actively identify and manage risk?”
Join Heather Davis, an industry veteran with more than 26 years of experience in clinical trials, for this informative webinar.