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.