How ICH E6(R2) Drove RBM for One Sponsor

With impending changes necessary to address ICH E6(R2), risk-based methodologies are top of mind. Sponsors must proactively answer important 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?

Learn how a mid-sized sponsor was able to address these questions through a meaningful risk assessment and approach to oversight. Working with limited resources, the sponsor was able to take advantage of industry best practices and automation to deliver an on-time project.

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How ICH E6 (R2) Drove a Mid-Sized Sponsor’s RBM Initiative

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