The event - held May 1st and 2nd at the Hyatt Regency in New Brunswick, New Jersey – is designed as a forum where sponsors and service providers can discuss how to operationalize best quality management and develop a set of industry standards.
Avoca CEO Patricia Leuchten told Outsourcing-pharma.com about the attendees and set out the event’s aims, explaining that: “We have sponsor companies that represent the largest outsourcing spend in the industry conferring with Avoca on the development of industry standards.
“We also have small to medium size companies that have robust approaches for quality management in place. They are providing their best practice approaches for Avoca consultants to consider as we work to develop these standards.
“We also have the top international CROs as well as small to medium sized service providers that are recognized as leaders in the industry that comprise our CRO Consortium membership to date.”
Attendees will include Amgen, Astellas, AstraZeneca, Biogen Idec, Bristol-Myers Squibb, Cerexa, Cubist, GSK, Grunenthal, Janssen, Imclone, Lilly, Pfizer, Purdue and Roche as well as CROs like Chiltern, Covance, Harrison Clinical Research, Icon, INC Research, Parexel, PharmaNet/i3, PRA, Quintiles, RPS and Theorem.
Leuchten also set out the event programme, explaining that: “Day one is a meeting of the pharma and biotech members of the consortium” explaining that the focus will be on reviewing the work done to date, including a presentation of interim results of benchmarking work Avoca did on approaches to oversight and quality management.
Day two – she continued - is open to all members of the Consortium – including CROs – and will be “an interactive session in which Avoca moderators will be engaging the audience and the panel members in discussion.”
Discussion topics include documentation of quality expectations, sponsor satisfaction of CRO performance as it pertains to quality, ways measuring the quality of trials, considerations in emerging regions and how strategic alliances between sponsors and CROs impact quality