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OmniComm Systems, Inc. (OTCBB:OMCM), a leading global provider of eClinical solutions, announced today that it was selected as the EDC System of choice by Menlo Park, CA based Intersect ENT for its RESOLVE Clinical Study, a Novel In-Office Treatment option for Chronic Sinusitis Patients.
"We selected OmniComm's system after considering many other options. Our decision was based on TrialMaster's natural and intuitive user interface, and its ability to seamlessly produce validated SDTM data exports created directly from the TrialMaster database. With SDTM datasets available shortly after commencing patient enrollment, we have significantly sped up the process of managing our study and identifying potential data issues. We anticipate that OmniComm's state of the art technology will allow rapid database closure, analyses and results that comply with FDA's expectations," said James Stambaugh, Vice President of Clinical Affairs and Reimbursement.
Intersect's new product, a Steroid Eluting Implant for Post Sinus Surgery Patients, is placed in vivo during a routine physician office visit, and is designed as a treatment alternative for patients with recurrent sinus obstruction. The RESOLVE Study plans to enroll 100 patients, at up to 20 U.S. sites.
"We are extremely pleased to be chosen by Intersect ENT to support their new product development," said Stephen Johnson, President and COO of OmniComm. "Intersect has developed a strong reputation for developing local drug delivery solutions to advance clinically proven therapies that improve the quality of life for many patients with ear, nose and throat conditions." Johnson further stated, "We are delighted to be partnering with them to offer solutions that will help them be more efficient in the collection and management of their clinical product development."