The Avoca Group, a research organization specializing in clinical outsourcing and client service, announced the formation of the Quality Consortium, a pharmaceutical industry consortium focused on quality management.
“The Avoca Group’s 2011 Report on Quality and CRO Oversight revealed some insightful data regarding industrywide dynamics between sponsors and CROs,” said Patricia Leuchten, president and CEO of The Avoca Group. “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.”
Under the direction and guidance of Leuchten and The Avoca Group, the Quality Consortium will bring together 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.
Jeff Kasher, PhD, Vice President and Chief Operating Officer, Global Clinical Development, at Eli Lilly and co-sponsor of the Quality Consortium, said: “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 continues adding members, including Amgen, Astellas, Biogen Idec, Bristol-Myers Squibb, Cubist, GlaxoSmithKline, Grunenthal and Purdue Pharma. 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.
Membership is still available for a limited time to qualifying organizations. The consortium’s work begins this month and the inaugural Quality Summit to review and share member insights and analyses, sponsored by PharmaNet/i3, is scheduled for May 2012. For membership inquiries or to become part of the consortium, contact Caryn Laermer at 609-799-0511 or visit the consortium’s website.
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.