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Eli Lilly & Co. and Pfizer, Inc. continue as lead Consortium sponsors
The Avoca Group, an industry-leading consulting and research organization specializing in clinical outsourcing and alliance management, announced today the Avoca Quality Consortium’s 2013 key initiatives. Building upon a successful launch year, the Avoca Quality Consortium will implement additional initiatives aimed at further enabling members to optimize approaches for proactive quality management of outsourced clinical trials.
Formed in January of 2012 with 29 members, The Avoca Quality Consortium brings together executives from pharma, biotech, and clinical research organizations (CROs) to accelerate the development of best practice approaches to quality management. Over the past year, the Consortium successfully completed the creation of a Clinical Quality Agreement template and a Quality Metrics initiative.
“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,” explained Patricia Leuchten, President and CEO of Avoca. “We made tremendous progress during our first year and are now poised to expand the scope of this critically important work.”
For 2013, the Quality Consortium will conduct a consortium-wide research assessment focused on managing risk in outsourced clinical trials. This will include an assessment of Consortium members’ approaches to managing risk compared to the overall industry’s approach.
“At a time of increasing regulatory expectations, industry collaboration to raise the bar on quality in critical trials is more important than ever, “said Jeff Kasher, Ph.D., Vice President, Clinical Trial: Materials, Implementation, and Transformation, Eli Lilly Co. “Our first year work produced very practical tools, which many members have already put into use. Our 2013 focus on guidelines and tools for effective oversight will continue in the same spirit: research that leads to useable tools to support proactive quality management.”
Research and work on leading practices in proactive quality management serve as the two pillars of the Avoca Quality Consortium. Members of the Avoca Quality Consortium will receive 2013 guidelines and tools focused on effective oversight, revisions and refinements to its quality agreement and metrics tools, Avoca research reports, participation in the May Summit and Fall Working Sessions, participation in regular WebEx Meetings and updates on work related to avenues for operationalizing approaches to proactive quality management.
Eli Lilly & Company and Pfizer, Inc. are founding corporate sponsors and will continue in that role during 2013. Jeff Kasher and John Hubbard, Ph.D., FCP, Senior Vice President and Worldwide Head Development Operations, Pfizer, Inc. will co-chair the Consortium’s Annual Summit set for May 8&9 in Princeton, NJ.