Sponsors continuously tell us that they are required to monitor and manage risk from various perspectives and under multiple FDA guidances. Complying with regulations such as ICH E6 (R2) while maintaining milestones and addressing issues are time-consuming and costly for them.
This webinar will present a case study of a leading pharmaceutical that faced multiple challenges affecting risk including:
|In a recent poll, sponsors were asked, “How significant a priority is risk reduction, including ICH E6 compliance for you and your team?” More than 70% claimed that risk reduction was a top priority.|
We will examine best practices for defining, analyzing and operationalizing the process of managing risk in the study conduct phase to answer questions such as:
- “How are my studies performing and where are the risks?”
- ”What are the reasons for enrollment leakage?”
- “What are the most common causes of protocol deviations?”
Join Comprehend Systems for an in-depth study and demonstration of how a leading pharmaceutical reduced risk and improved productivity across studies and portfolios.
We look forward to you joining us!
Julie Peacock, Clinical Intelligence Expert, Comprehend
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.