Interim findings from the 2017 Avoca Industry Research on Risk in Clinical Trials indicate that only 33% of sponsors are satisfied with their providers’ (CROs/FSPs) level of expertise and experience in applying risk-based approaches to quality management.
With impending changes necessary to address ICH E6(R2), oversight is top of mind and requires sponsors to proactively answer a variety of questions:
- Is my vendor doing what I hired them to do?
- Is the CRO adhering to my quality plan?
- Is the CRO’s performance meeting our expectations?
- What issues should we be escalating?
Watch this webinar and learn oversight best practices.