Wednesday, February 8, 2012

Pharma Industry Consortium Tackles Clinical Trial Quality Management

Inside Outsourcing Interview Series Probes Push for Standardized Quality Metrics

By Marc Dresner, IIR

The clinical outsourcing industry got a jolt in December when a dozen bio-pharmas—including five of world’s largest manufacturers—announced they had formed a Quality Consortium to establish and standardize metrics and best practices in clinical trial quality management.

The initiative is being coordinated and managed by clinical outsourcing research and consulting firm The Avoca Group, whose 2011 industry report on quality and CRO oversight identified widespread dissonance between sponsors’ quality expectations and CROs’ ability to deliver on them given years of downward pricing pressure and compressed timelines.

(Editor: To purchase The Avoca Group report at a 15% discount click here and enter the code PARTNERSHIPS.)

According to The Avoca Group’s executive director of survey research and relationship management, Denise Calaprice-Whitty, “sponsors and service providers have realized that they really need to get on the same page, but this is relatively uncharted territory, and many of them aren't sure what to include in their quality agreements.”

Mitchell Katz, executive director of medical research operations at Purdue Pharma—a founding member—added that the FDA’s dual mandate for closer oversight of outsourced trials by sponsors and the inclusion of quality management systems to ensure compliance prompted sponsors to unite in pursuit of an industry-level solution.

“We are in desperate need of something that is not just defined by each individual company; we need to set a standard for all companies,” Katz told Inside Outsourcing.

In this exclusive podcast interview for Inside Outsourcing: Spotlight on Clinical Trial Partnerships, Katz and Calaprice-Whitty discuss:

- Quality agreements: components and negotiation
- Challenges facing sponsors and CROs
- KPIs vs Quality Metrics
- Quality Consortium plans and progress

Listen to this episode of Inside Outsourcing!

Read the interview transcript!

EDITOR’S NOTE: Inside Outsourcing: Spotlight on Clinical Trial Partnerships is brought to you by the producers of the 21st annual Partnerships in Clinical Trials conference and exhibition—the world’s premier gathering for clinical development leaders and practitioners—taking place March 4-7 in Orlando, FL.

As a reader of this blog, when your register to join us this March in Orlando and mention code XP1700BLOG, you'll receive a 15% discount off the standard rate. Visit the webpage for more information.

Learn more about the Quality Consortium.

Ps. For a candid take from senior executives on the state of sponsor/CRO partnerships and industry trends, tune in to PartnershipsTV™ —the official streamcast network of Partnerships in Clinical Trials!

Marc Dresner is IIR USA’s communication lead for audience engagement. He is the former executive editor of Pharma Market Research Report, a confidential newsletter for market research professionals specializing in the pharmaceutical, biotech and healthcare industries. He may be reached at Follow him @mdrezz. Meet him at the 2012 Partnerships in Clinical Trials conference in Orlando this March!

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