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.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Gilead Shares Final Data from Phase III MYR301 Trial of Bulevirtide in Chronic Hepatitis Delta Virus
May 7th 2025Long-term results from the study show 90% of patients with chronic HDV who achieved undetectable HDV RNA at 96 weeks of treatment remained undetectable for nearly 2 years post-treatment.