Video

Implementing ICH E6(R2): Getting the Balance Right

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.

Karen McCarthy Schau of CGI and Julie Peacock of Comprehend Systems 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 recording, we’ll 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.

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