The Avoca Group, a Princeton, N.J.-based consulting and research organization specializing in clinical outsourcing and alliance management, held its second annual Avoca Quality Consortium Summit May 8 and 9. Last year, Avoca formed the industry‐wide Avoca Quality Consortium, bringing together quality, outsourcing and operational professionals from member pharma, biotech and CROs to accelerate the development of a best practice approach to quality management and oversight of outsourced clinical research.

The Summit engaged more than 100 senior executives from large to small pharma companies and leading service providers in discussions on effective clinical trial oversight, risk assessment and risk management, change management and creating a culture of quality.

The consensus: The industry must move toward a more proactive approach to quality management and risk management. While no “one size fits all” formula can be applied to all organizations, the Consortium has been able to bridge gaps and develop mutually agreed upon standards of quality that have a built‐in flexibility with tailored modules that companies can adapt and implement to meet their organization’s needs and pave the way for improved outcomes.

This year, the Consortium, which now has more than 30 sponsor and CRO member companies, is focusing on creating specific guidelines and tools for proactive quality management and effective oversight. It also has conducted an assessment on member company approaches to risk assessment, management and sharing in outsourced clinical trials. Avoca is collaborating with the Metrics Champion Consortium and participates in ongoing discussions with CTTI and Transcelerate to ensure no duplication of efforts.

“Providing insights, standards and tools for proactive quality management and effective oversight will have a significant, positive impact on the industry in terms of ensuring efficiency while focusing on maintaining high quality,” said Patricia Leuchten, CEO of The Avoca Group.