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.