Implementing ICH E6(R2): Getting the Balance Right

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical,
  • Wednesday, December 05, 2018

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.


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.

Message Presenter

Julie Peacock, Client Services, 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.

Message Presenter

Who Should Attend?

CROs, Clinical Operations and Data Management Professionals, including those involved in:

  • Clinical Trial/Clinical Study Management
  • Clinical Data/Informatics/IT
  • Clinical Outsourcing
  • Clinical Project Managers/Directors
  • Director of Project Delivery

Clinical Research, Technology and Business Professionals, including those involved in:

  • Biometrics/Biostatistics
  • Business Technology/Applications/Solutions
  • Business Analyst
  • CTO
  • Project Management

What You Will Learn

Join this webinar to gain insights into:

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

Xtalks Partners


Comprehend provides a suite of cloud applications and consulting services that dramatically improve the clinical trial process. Our solutions deliver actionable risk and performance insights across studies, systems, sites, and vendors. By using elements of our Clinical Intelligence Platform to unify, monitor, and analyze data across all sources, sponsors and CROs alike are able to reduce risk, achieve milestones on time, and stay within budget. As a trusted partner, Comprehend helps speed the time to quality results.


Founded in 1976, CGI is among the largest independent IT and business consulting services firm in the world. With 74,000 professionals across the globe, CGI delivers an end-to-end portfolio of capabilities, from IT and business consulting to systems integration, outsourcing services and intellectual property solutions. CGI works with clients through a local relationship model complemented by a global delivery network that helps clients digitally transform their organizations and accelerate results.

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