Case Study

How ICH E6 (R2) Drove a Mid-Sized Sponsor's RBM Initiative
Date: Wednesday, June 20th, 2018
Time: 10am PT (1pm ET)
Duration: 30 minutes

With impending changes necessary to address ICH E6 (R2), risk based methodologies are top of mind and requires sponsors to proactively answer questions such as:

  • “Is my vendor doing what I hired them to do?”
  • “Is the CRO adhering to my quality plan?”
  • “Do we have the right level of oversight based on a risk profile?”
  • “What issues should we be escalating?”

Join Julie Peacock of Comprehend for an insightful discussion on how a mid-sized sponsor was able to address these questions through a meaningful risk assessment and approach to oversight.  Working with limited resources they were able to take advantage of industry best practices and automation to deliver an on time project.

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Additionally, attendees will see a live demonstration of how this sponsor put their plans into practice and the insights gained into their oversight process.

Featured Speaker:

IMG_0834.pngJulie 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.