Implementing ICH E6(R2): Getting the Balance Right
Date: December 5th, 2018
Time: 10am PT (1pm ET)
Duration: 60 minutes

Register

You have created a project to address R2 guidance, identified partners, and started sharing data. Now what? Are you dealing with information overload? If so, you are not alone.

In light of the ICH E6(R2) guidelines, sponsors and CROs are assessing how well they work together. This webinar will include real-world stories that explain where to draw the line on roles and responsibilities, reveal relevant metrics and the data that drives them, and show how your R2 process can run more efficiently.

Join Karen McCarthy Schau of CGI and Julie Peacock of Comprehend Systems as they dive into best practices of defining the ownership, prioritization, and application of the data that is being shared.

You’ll gain insights into:

  • Data transfer frequency and sources
  • Defining clear partner processes
  • Appropriate metrics and measurement
  • Elimination of manual processes and spreadsheets

During the webinar, featured speakers will share a case study that shows how a sponsor with ICH E6(R2) as its guiding principle was able to phase its approach. In doing so, the sponsor learned what was most beneficial and what to avoid in future phases, while still meeting its objectives.

Featured Speakers

 

Karen Schau

Karen McCarthy Schau, Director Consulting Services, Health & Life Sciences, CGI

Karen is a clinical research/clinical management professional with 20 years of diversified experience across functional areas and global regions. She is actively engaged in clinical operations business process improvement consulting and clinical systems deployment, with emphasis on eTMF, risk-based quality management (RBQM), investigator portal, CRO engagement, and clinical architecture. Karen’s career includes 10 years specializing in process re-engineering and system implementation for a large global CRO. She currently focuses on helping companies deploy solutions to streamline processes, improve productivity and operational efficiency, and better manage information. She is a member of the MCC Metrics Consortium.

 

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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.