In a past Comprehend webinar on CRO oversight, The Avoca Group laid out a process for building an Oversight Capability and Maturity Model (OCMM). This best practice approach was designed in cooperation with the Avoca Quality Consortium, an industry-wide collaborative that brings together a group of more than 100 sponsors, CROs, and clinical service providers to improve quality management in outsourced clinical research. The Avoca Quality Consortium was born out of the realization that there are significant gaps in alignment between sponsors’ expectations and CRO service delivery.
Avoca’s OCMM 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. The ICH E6(R2) addendum requires risk-based approaches be utilized in all aspects of clinical trials, with sponsors being the responsible parties. These risk-based approaches to clinical trial execution add a more complex layer to oversight.
The OCMM covers strategy, leadership, metrics, and other aspects of oversight. Within each dimension are five levels of maturity, linked to various positioning and measurement tools. The model includes 50 detailed descriptions of capability, designed to help sponsors identify improvement areas 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.
Following the discussion of the OCMM in the webinar, Comprehend presented feedback from its own 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 of those were 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 about their top challenges to enabling successful CRO partnerships, the majority of webinar attendees cited not having mutually agreed upon metrics.
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. In order 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. At the same time, the sponsor was uncertain about the quality of data provided by the CRO, which could potentially cause serious risk and audit issues.
With a plan for continuous oversight, the sponsor was able to monitor its quality agreements and manage issue resolution collaboratively, all in real time. This effective plan included the following key elements:
Continuous confidence in relevant data.
Quality Agreements and Oversight Plans
Continuous CRO accountability and enhanced trust.
Collaborative Task Management
Automated notification of threshold breaches to key stakeholders, who can assign tasks and follow up with fully auditable documentation.
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 aggregated data and automated quality agreements and oversight plans, the sponsor was assured that they were adhering to ICH E6(R2). The sponsor became an active collaborator with its CROs, in order to meet milestones and improve quality.
For more details on using automation and establishing your own OCMM, watch our webinar now.
Editor’s Note: Since this blog was first posted in 2017, we’ve made it even easier to manage oversight with the Comprehend Oversight Scorecard. This powerful new data visualization and analytics solution delivers a quick, comprehensive overview of risk, quality, and performance indicators across a single study or an entire portfolio. With the Oversight Scorecard, users can monitor scores for sites, studies, countries, and vendors—based on pre-selected metrics—to make better, faster decisions.
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 about how Avoca can help your organization, please contact Beth Lisathaus.
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