Thursday, May 26th

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As the FDA tightens scrutiny of outsourced clinical trials and issues increasing numbers of high profile warning letters, the pharmaceutical industry is responding. Instead of safeguarding their best practice approaches — trade practices they've spent years developing — industry leaders are coming together to share insights and develop higher quality management standards that will benefit both the industry and consumer safety.

This spirit of collaboration to enhance the quality of outsourced clinical trial conduct was the brainchild of Patty Leuchten, founder and CEO of The Avoca Group. Avoca specializes in relationship and alliance management, bringing pharmaceutical companies and contract research organizations (CROs) together in the early stages of product development.

According to Leuchten, the FDA letters were a wake-up call for many leading organizations. "This is partly why I formed The Avoca Quality Consortium," she said. "It's a direct response to some of the external challenges companies are facing to ensure high quality in the conduct of outsourced clinical trials while also working very efficiently."

By bringing top players from pharma, biotech and CROs together, Leuchten believes the consortium will help create high standards for outsourced clinical trials based on proactive quality management.

"We now have 25 members and are just getting going," Leuchten said."We're very excited with how many companies are involved and engaged in this initiative. They are willing to be open and collaborative so that, as a group, we can be better as an industry, which ultimately will affect patient safety."

Avoca understands the nuances of clinical research and clinical outsourcing. By carefully monitoring industry trends, they are able to help clients stay ahead of the curve. "We are not generalists. We are subject matter experts," Leuchten said. 

"The trends we focus on are related to how companies are changing and evolving. A major trend is a consolidation of spending with fewer outsourcing partners." Leuchten said, adding that this is in response to pressure within the industry to reduce costs and time lines while increasing efficiency.

As pharmaceutical companies work with fewer providers, relationships with those providers become critical to the success of product development. Avoca's survey and research data help clients discover what is working and what isn't in these alliances.

This specialized knowledge and in-depth understanding of the industry enabled Avoca to embark into the uncharted territory of setting global quality management standards. "We are bringing together the giants of an industry to do something that will have significant impact and that has never been done before," Leuchten said. "The possibilities and potential for this are very exciting."

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