Wednesday, March 19, 2014

Pharma Consortium Preps Clinical Trial Quality Guidelines

Standards for Niche Supplier Pre-Qualification also on Agenda

By Marc Dresner

The Avoca Quality Consortium—comprised of more than 30 pharma, biotech and clinical research companies—is preparing an array of detailed guidelines, tools and templates aimed at standardizing quality management in outsourced clinical trials.

According to Patty Leuchten, president and CEO of the Avoca Group, which founded the industry collaborative in 2012 with sponsors Eli Lilly and Pfizer, the toolbox will build on a framework of eight components developed last year.

The rollout, expected later this year, will be accompanied by a series of educational webinars for each of the respective categories.

Guidelines, tools and templates for eight components of effective quality management will be based on a best practice framework developed last year. 

Patty Leuchten
“We’re designing tools and resources around governance, communication, risk assessment, metrics, oversight, leadership—all of the essentials for proactive quality management and oversight of outsourced clinical trials,” Leuchten told Inside Clinical in a podcast interview.

The Quality Consortium also plans to produce standards for pre-qualifying niche and third-party service providers, a project undertaken at the behest of Consortium members and a much-needed first for the industry, Leuchten noted.

Sponsors and CROs all pre-qualify ancillary suppliers using criteria sufficiently different to create a huge strain.

“Sponsors and CROs all pre-qualify ancillary and niche suppliers using a similar set of criteria, but the criteria are sufficiently different to create a very big strain,” Leuchten said.

“Developing pre-qualification standards will have a huge impact on reducing cost and inefficiency in this space,” she added.

Stay tuned for the final segment of Inside Clinical’s interview with Patty Leuchten, where we’ll really dig into the state of sponsor/CRO strategic partnering, the latest developments and some dramatic trends in this rapidly evolving space!
Editor’s note: The Avoca Group will present its 2014 research data for the first time at the 23rd Annual Partnerships in Clinical Trials conference running March 30-April 2 in Las Vegas.  And as a reader of this blog, when you register to join us and mention code XP1900BLOG, you'll save $100 off the current rate!

For more information or to register, please visit

Marc Dresner
Marc Dresner is IIR USA's senior editor and special communication projects lead. He is the former executive editor of Pharma Market Research Report, a confidential newsletter for marketing researchers in the pharmaceutical industry. He may be reached at Follow him @mdrezz.

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