A consortium-wide research assessment focused on managing risk in outsourced clinical trials is one of the initiatives the US-based Avoca Quality Consortium will be pursuing during its second year of operations.

Set up in January 2012 by The Avoca Group, a consulting and research organisation that specialises in clinical outsourcing and alliance management, The Avoca Quality Consortium brings together quality, outsourcing and operational professionals from pharmaceutical and biotechnology companies, as well as contract research organisations, to accelerate the development of best-practice approaches to quality management and CRO oversight.

Over the past year, the Consortium has created a Clinical Quality Agreement template and completed a Quality Metrics initiative, Avoca noted.

The focus in 2013 will be on guidelines and tools for effective oversight, continuing “in the same spirit: research that leads to useable tools to support proactive quality management”, said Jeff Kasher, vice president, clinical trial: materials, implementation, and transformation at Eli Lilly.

Corporate sponsors

Lilly was one of the founding corporate sponsors of The Avoca Quality Consortium, along with Pfizer.

Both companies will maintain that role during 2013, with Kasher and John Hubbard, senior vice president and worldwide head, development operations at Pfizer, co-chairing the Consortium’s Annual Summit scheduled for 8-9 May in Princeton, New Jersey.

The aforementioned research assessment on risk management in outsourced clinical trials will include looking at Consortium members’ approaches to managing risk compared with the overall industry approach.

“Our overarching goal is to help our diverse members strike the right balance between meeting timelines, ensuring cost containment and achieving the highest level of quality in their clinical trials,” commented Patricia Leuchten, president and chief executive officer of Avoca. 

“We made tremendous progress during our first year and are now poised to expand the scope of this critically important work.”