Best Practices for CRO Oversight: How an Oversight Capability Maturity Model and Automation

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…

Best Practices for CRO Oversight: How an Oversight Capability Maturity Model and Automation

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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.

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