In a recent Comprehend webinar, The Avoca Group laid out the process they undertook to build an Oversight Capability and Maturity Model. This Best Practice model was designed in cooperation with the Avoca Quality Consortium, an industry-wide collaborative that brings together a group from more than 70 member companies from sponsors, CROs and clinical service providers to improve quality management in outsourced clinical research. The concept for the Avoca Quality Consortium was born from the realization that there are significant gaps in alignment between sponsors’ expectations and CRO service delivery.
Avoca Group’s Oversight Capability Maturity Model
Avoca’s Oversight Capability and Maturity Model was developed for companies to assess their current level of oversight maturity and provides tools, templates and guidelines to achieve a higher level of oversight maturity. According to interim findings from the 2017 “Avoca Industry Research on Risk in Clinical Trials,” only 33% of Sponsors are satisfied with their Providers’ (CROs/FSPs) level of expertise and experience in applying risk-based approaches to quality management overall. The ICH E6 (R2) addendum, requires risk-based approaches be utilized in all aspects of clinical trials with the responsibility of quality lying with the sponsor. These risk-based approaches to clinical trial execution add a more complex layer to oversight.