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.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.