PRINCETON, N.J., May 25, 2017 /PRNewswire/ -- At its annual Summit USA in New York City on May 10-11, 2017, the Avoca Quality Consortium (AQC) released a "Regulatory Roadmap" -- a set of practical guidelines, tools, and documents -- to empower its Members to understand the recently rolled out ICH E6 R2 regulations and apply leading-practice solutions.
"Because Avoca began this work five years ago, we were well prepared to support the industry when the new regulatory guidelines were released," says Patricia Leuchten, CEO of the Avoca Group.
Covering clinical trial management and oversight in Europe and the United States, ICH E6 R2 requires that organizations adopt documented quality risk management processes. It calls on drug development professionals to make decisions based on a careful weighting of the likelihood and consequences of various risks.
Avoca's Regulatory Roadmap will help biopharmaceutical companies and clinical research organizations (CROs) adapt to the new regulations more quickly.
Since 2011, AQC Members have collaborated to encourage proactive approaches to risk management, oversight, and quality. Based on Member input, The Avoca Group began developing leading practice documents five years ago in anticipation of regulatory changes that would mandate a more proactive approach to managing quality and mitigating risk.
ICH E6 R2 makes much of what the Consortium envisioned a reality. "Our leading practice documents, which are now mapped to ICH E6 R2, will give AQC Members a 'roadmap' to regulatory changes that will influence how we, as an industry, oversee quality," says Leuchten. "Our work earlier this year was focused on helping our Consortium Members make sense of ICH E6 R2. We linked already available tools, templates, and documents to the new regulations and created 17 new tools to help our Members navigate and implement ICH E6 R2 within their organizations."
Quality is the mission of the AQC. Strict adherence to quality management leads to the successful trials that bring medicines to patients who need them. The AQC's annual Summit gives sponsors and clinical service providers a unique chance to collaboratively address issues of mutual concern in the clinical trial landscape. "As complexity increases, so too does the need for collaboration between all stakeholders in the clinical trial process," says Coleen Glessner, Senior Vice President, Chief Quality Officer, Alexion, and Summit emcee. "The AQC provides a unique environment where industry leaders, from both sponsors and CROs, come together to collectively discuss regulatory changes, create proactive approaches, and leverage what is available to the industry through the AQC."
December 2016 was the fifth anniversary of the Quality Consortium, and 2017 is the second year that, due to Member interest, the AQC will hold a Summit in Europe -- to take place in Dublin June 7-8. Ideas discussed at the Summit are later put into practice through the work of the Consortium. At the Dublin meeting, the AQC Regulatory Roadmap will be discussed and rolled out to a European audience.
The New York Summit's primary sponsor was ICON, the global CRO that has headquarters in Dublin. Also sponsoring the Summit were InVentiv Health, Purdue Pharma, Bioclinica, Longboat, Appian, and MedAvante.
Participating leaders included:
Dimitris K. Agrafiotis, PhD, FRSC, Chief Data Officer, Covance; Paul Gilbert, Co-Founder & Chief Executive Officer, MedAvante; Brian Hagen, PhD, Founder and Managing Director, Decision Empowerment Institute; Jeff James, Executive Vice President, Alliance Management, ICON; Andy Lee, Senior Vice President, Head of Global Clinical Trials Operations, Merck; Robert Metcalf, PhD, Vice President, MDU Diabetes and Clinical Transformation, Eli Lilly and Company; Adrian Otte, MB, BCh, FFPM, Vice President Global Development Operations, Amgen; and Roni Zeiger, MD, Co-Founder and CEO, Smart Patients.
"We're grateful to our sponsors and the industry leaders who joined us to provide their insights and lead such thought-provoking and inspiring conversations. The leading practices discussed and debated at the Summit will define Avoca's agenda in coming months," says Leuchten.
While much discussion at the Summit was focused on technical issues, panelists and attendees also raised critical questions about how to continue to build a culture of quality within individual organizations. "The landscape of clinical trials is evolving, and the pace of change is rapid," says Patricia Leuchten, CEO of the Avoca Group. "The Summit is an opportunity for us as an industry to prioritize opportunities and make decisions about how to address the complexities we face for the collective benefit of the industry."
About The Avoca Quality Consortium (AQC) and the Avoca Group
Sponsored by Eli Lilly and Pfizer and led by The Avoca Group, The Avoca Quality Consortium (AQC) brings together 70+ pharma, biotech, and clinical service companies that share a commitment to collaboratively improving the execution and management of outsourced trials. Members have access to a large and growing repository of 250+ leading practice tools, guidelines, and standards that deliver meaningful improvements to the speed, efficiency, and quality of clinical trial execution, as well as the means to track and influence the development of innovative new approaches.
Since its inception in 1999, The Avoca Group has delivered high-quality, actionable research to pharmaceutical companies, CROs, and specialty service providers. A pioneer in clinical outsourcing research and consulting, Avoca has tracked and influenced the progression of the sector, making it the ideal partner for companies seeking to continuously improve the execution of clinical trials.
For more information, visit theavocagroup.com.
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SOURCE Avoca Quality Consortium