Clinipace to Manage Two Phase II Clinical Trials for Inspire Pharmaceuticals

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Wed May 27, 2009 9:00am EDT

Clinipace`s Technology-Driven Service Model is Designed to Streamline Timelines
and Generate Significant Clinical Trial Transparency and Cost Savings
MORRISVILLE, N.C.--(Business Wire)--
Clinipace, a digital clinical research organization, announced today that
Inspire Pharmaceuticals, Inc. has selected the company to manage and deploy two
phase II studies for the ophthalmic prescription medicine, AzaSite®. 

Currently approved by the U.S. Food and Drug Administration (FDA) for the
treatment of bacterial conjunctivitis, Inspire has initiated two Phase II
randomized placebo-controlled clinical trials of AzaSite as a potential
treatment of blepharitis, an ocular disease characterized by the inflammation of
the eyelids. 

Clinipace will provide technology-driven clinical trial services to Inspire
including data management (EDC), clinical monitoring, site management,
regulatory document management, and biostatistical consulting. To bring
increased trial visibility, the project team will utilize TEMPOTM for Clinical
Trials software from Clinipace to manage site initiation, patient enrollment and
randomization, clinical data capture, monitoring trip reports, site management,
regulatory document tracking, and much more. 

"We share a common goal with Clinipace of changing the way we approach the
clinical development process - shifting away from some of the more traditional
CRO processes and moving towards an integrated technology-driven model," said
Chad Ice, senior director, clinical research, Inspire. 

"With Clinipace, we plan to remove unnecessary layers of management and
processes," said Ice. "We believe that Clinipace can help assure that
communication with our clinical sites is much more seamless - one of the most
vital links driving the success of our clinical trial process." 

"We`re hearing from the market time and time again that pharmaceutical companies
are tired of having over-scaled and over-priced resources pitched to them from
CROs today," said Christopher Porter, chief operating officer, Clinipace.
"That`s the driving force behind our dedication to providing innovative
companies like Inspire a scalable solution with the right kind and quantity of
resources to match any size clinical study and operational approach." 

About Clinipace

Clinipace, an experienced digital clinical research organization (dCRO),
provides on-demand software and clinical services for phase I-IV clinical
trials, registries, and investigator-initiated grant management programs. We
serve biopharmaceutical and medical device companies as well as academic medical
centers. Optimized by TEMPO, our web-based software platform, we deliver
clinical trial and registry services at up to a 30% savings compared to
traditional service providers. Learn more at http://www.clinipace.com. 



Crossroads Public Relations for Clinipace
Molly Thompson, 919-821-2822
Senior Account Executive 

Copyright Business Wire 2009

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