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.
The Oversight Capability Maturity Model (OCMM) five steps to maturity
The Oversight Capability Maturity Model includes 10 different dimensions for Oversight Capability, such as Strategy, Leadership, Metrics, etc. Within each of the dimensions are the five levels of maturity, linked to tools to help the organization position and measure themselves. The model includes 50 detailed descriptions of capability. With this information, sponsors can more easily identify where they need to improve, and quickly advance their Oversight objectives. The model helps them drive greater efficiency and quality, reduce cycle time and risk, enable fewer findings during audits and regulatory inspections, and support better, more effective partnerships.
The Facts about CRO Oversight
Following the discussion of the OCMM, Comprehend presented feedback from its research into CRO Oversight. Attendees confirmed findings that sponsors are not yet fully enabled to make oversight operational. In fact, less than 35% had begun oversight processes, and most at a rudimentary level.
|More than 65% of webinar attendees noted that they were still in the early stages of making oversight operational at their organizations.|
When asked, “What is the top challenge to enabling a successful CRO partner relationship?” webinar attendees reported that their most significant challenge was not having mutually agreed upon metrics with their CROs.
Case Study: Achieving CRO Oversight with Automation and Best Practices
Focusing on how to solve these challenges, Comprehend presented a case study of a sponsor who had applied automation to address resource, quality and risk issues. The sponsor needed to add 50% more trials without adding headcount. The VP of Clinical Operations had to optimize its resource pool through collaboration with CROs, while improving visibility and productivity across increasingly complex trials. There was a level of uncertainty about their data, causing risk and potential audit issues.
With a plan for Continuous Oversight, this sponsor was able to define Quality Agreements, assign responsibility for ownership, work from the same data, and predict and manage issues and escalation – all in collaboration with its CROs and in real-time.
The sponsor applied a continuous oversight approach to:
|Aggregation of Data
Continuous certainty of all relevant and quality data
|Quality Agreements and Oversight Plans
Continuous certainty that the CROs are adhering to the quality plan
|Automated Risk Identification
Continuous updates with notifications of threshold breaches, shared between CRO and Sponsor
The result? The sponsor added a new CRO and new studies with no additional headcount, improved cycle time, increased CRA productivity by hundreds of hours and saved thousands of dollars in site management fees and CRO change orders.
Comprehend‘s Clinical Intelligence Suite helped this sponsor with real-time oversight of their CROs. With automated quality agreements and oversight plans and aggregated data, they were assured that they were adhering to ICH E6 (R2). They became an active collaborator with their CROs to meet milestones and improve quality.
For more details, please see our webinar.
About the Avoca Group
The Avoca Group is an integrated research and consulting firm providing survey research, consulting services and training in the areas of clinical trial outsourcing, strategic alliances and quality management. The company’s focus is to help solve complex clinical trial challenges and to improve the quality and efficiency of clinical trial execution. Founded in 1999, the company works exclusively in the healthcare industry and has a focus on clinical research and clinical outsourcing.
To find out more on how Avoca can help, please contact Beth Lisathaus.