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by wendy connick                                             setting new standards                                        ...
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'Setting New small company brings industry giants together'


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'Setting New small company brings industry giants together'

  1. 1. by wendy connick setting new standards One small company brings industry giants together A s the FDA tightens scrutiny of many companies are involved and outsourced clinical trials and engaged in this initiative. They are issues increasing numbers willing to be open and collaborative of high profile warning letters, so that, as a group, we can be better the pharmaceutical industry is as an industry, which ultimately will responding. Instead of safeguarding affect patient safety.” their best practice approaches — Avoca understands the nuances trade practices they’ve spent years of clinical research and clinical out- developing — industry leaders are sourcing. By carefully monitoring coming together to share insights and industry trends, they are able to help develop higher quality management clients stay ahead of the curve. “We standards that will benefit both the are not generalists. We are subject industry and consumer safety. matter experts,” Leuchten said. This spirit of collaboration to en- “The trends we focus on are re- hance the quality of outsourced clini- lated to how companies are chang- “ Patty Leuchten, CEO: The Avoca Group cal trial conduct was the brainchild ing and evolving. A major trend is a of Patty Leuchten, founder and CEO consolidation of spending with few- of The Avoca Group. Avoca spe- er outsourcing partners.” Leuchten cializes in relationship and alliance said, adding that this is in response management, bringing pharmaceu- to pressure within the industry to tical companies and con- reduce costs and time lines while in- tract research organiza- creasing efficiency. The trends we focus tions (CROs) together in the early stages of product As pharmaceutical companies work with fewer providers, relation- on are related to how development. ships with those providers become According to Leuchten, critical to the success of product companies are changing the FDA letters were a development. Avoca’s survey and wake-up call for many research data help clients discover and evolving.” leading organizations. what is working and what isn’t in - Patty Leuchten “This is partly why I these alliances. formed The Avoca Qual- This specialized knowledge and ity Consortium,” she said. in-depth understanding of the indus- “It’s a direct response to some of the try enabled Avoca to embark into the external challenges companies are uncharted territory of setting global facing to ensure high quality in the quality management standards. “We conduct of outsourced clinical trials are bringing together the giants of an while also working very efficiently.” industry to do something that will By bringing top players from have significant impact and that has pharma, biotech and CROs together, never been done before,” Leuchten Leuchten believes the consortium said. “The possibilities and potential will help create high standards for for this are very exciting.” 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 howTHE SUIT MAGAZINE - APR / MAY 2012