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 will dive into best practices for the identification and ongoing management of risk during the clinical trial process. We will also present a case study of a leading pharmaceutical company that faced multiple challenges affecting its risk profile.
We’ll 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, and Comprehend for this informative webinar.
Meet the Speakers
Heather brings more than 26 years of experience in clinical trials project management, clinical monitoring, and operational strategy across the biotech and CRO industries, with a specialty in oncology clinical trials.
She holds a bachelor’s degree in Environmental Studies: International & Environmental Development from the University of Colorado at Boulder.
Closely aligned with customers and the sales organization, Julie focuses on enabling prospects and customers on Comprehend’s Clinical Intelligence solutions. She manages go-to-market strategy, sales enablement, and product marketing.
Prior to Comprehend, Julie spent 18 years at Oracle Corporation in the enterprise application space, where she managed strategy, field enablement, and launch activities for a series of BtoB solutions.
Julie holds a bachelor’s degree in Marketing from Auburn University.