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
www.theavocagroup.com 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 how
THE SUIT MAGAZINE - APR / MAY 2012