Big Pharma, CROs Gear Up for Summit Focused on Outsourced Trial Quality

Related tags Clinical trial Pharmaceutical industry Contract research organization

Some of largest pharmaceutical, biotech and CRO (contract research organizations) companies are beginning preparations for a summit in May to focus on how to manage quality in the outsourcing of clinical trials.

The Avoca Quality Consortium's Summit will include more than 100 representatives from some of the largest CROs, such as Covance and Icon, as well as drug companies, including Pfizer, Eli Lilly and AstraZeneca. PPD and Sanofi are the latest companies to join the consortium.

We are optimistic that more can be done that will benefit our industry as a whole​,” James D. Esinhart, CEO of Chiltern told Outsourcing-Pharma.com in anticipation of the summit. He said the company is “eager to share​” its experiences on areas such as the pre-qualification of service providers, and the adoption of common tools that add transparency and cut costs and time.

The summit includes one working day for private discussions between CRO and pharma member companies and one day that’s open to the public. The sessions on the first day will include discussions of Avoca’s industry and consortium research findings and best practices for partnerships, while sessions in the second day will feature an overview of the expectations that the FDA has for sponsor companies and CROs for managing risk and project oversight. Co-chairs of the summit will be Lilly VP Jeff Kasher and Pfizer senior VP John Hubbard.

I expect that the consortium members will further define efforts around proactive quality management, and, continue to align expectations and practices between CROs and sponsors​,” John G. Potthoff, president and CEO of Theorem Clinical Research, told us. “For my own goals, I would like to leave the meeting with a collaborative understanding on what elements drive quality prior to starting a clinical trial, and, defocus on metrics that are likely unrelated to quality​.” 

Patricia Leuchten, President and CEO of Avoca, also told us that the consortium will aim to strike the right balance between meeting timelines, ensuring cost containment and achieving the highest level of quality in outsourced clinical research.

Chiltern believes the Avoca summit is “unique by bringing together broad representation from our industry, with open dialog in a collaborative setting, focusing on quality issues that matter to everyone​,” Esinhart added.

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