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Avoca Group Forms CRO Quality Consortium

Sponsors include Lilly, Pfizer

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

The Avoca Group has formed the Quality Consortium, a pharmaceutical industry consortium focused on clinical quality management. Under the direction and guidance of The Avoca Group and its president and chief executive officer, Patricia Leuchten, the Quality Consortium will bring together lead sponsors Eli Lilly and Pfizer, other pharmaceutical and biotech companies, and leading CROs to create standards for quality management, initially with a focus on quality agreements and metrics. The consortium’s long-term goal is “the development of a new paradigm in the industry’s approach to quality management and partnering with CROs to ensure high quality and risk mitigation,” according to a press statement.

“The Avoca Group’s 2011 Report on Quality and CRO Oversight revealed some insightful data regarding industrywide dynamics between sponsors and CROs,” said Ms. Leuchten. “Through our analysis we identified opportunities to potentially improve outcomes through collaboration in quality management and metrics. The Quality Consortium will effectively share industry best practices and establish new standards.”

Jeff Kasher, Ph.D., vice president and chief operating officer, global clinical development, at Eli Lilly and co-sponsor of the Quality Consortium, said, “At Eli Lilly, we place a high priority on the success of our CRO partnerships. We are excited about our sponsorship and participation in the Quality Consortium and look forward to the possibility of quality oversight standardization. We believe that by establishing industry standards for quality oversight we can optimize our partnerships with CROs and improve our ability to ensure data integrity and patient safety.”

In addition to sponsors Eli Lilly and Pfizer, the consortium has added members at Amgen, Astellas, Biogen Idec, Bristol-Myers Squibb, Cubist, GlaxoSmithKline, Grunenthal and Purdue Pharma. According to a press statement, “Members will collaborate with industry professionals, share quality management best practices with colleagues and experts, gain specific tools and knowledge that will have immediate impact in enhancing their organizations’ approach to oversight, and identify and proactively address current gaps between pharmaceutical sponsors and CROs.”

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