Clinipace To Manage Two Phase II Clinical Trials For Inspire Pharmaceuticals

Main Category: Eye Health / Blindness
Also Included In: Clinical Trials / Drug Trials
Article Date: 29 May 2009 - 3:00 PDT

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Clinipace, a digital clinical research organization, announced 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."

Source
Clinipace