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

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?”

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 they were able to take advantage of industry best practices and automation to deliver an on time project.

Saama can put you on the fast track to clinical trial process innovation.