SmartPill Diagnostics, Inc., developer of the SmartPill Capsule, a non-invasive, ingestible medical device that captures physiological parameters from within the GI tract, today announced that it has selected Cognigen Corporation (Amherst, NY) to provide clinical research organization services to the phase II 510(K) clinical trials of the SmartPill Capsule System.
Buffalo, NY (PRWEB) December 3, 2004 -- SmartPill Diagnostics, Inc. (www.smartpilldiagnostics.com), developer of the SmartPill Capsule, a non-invasive, ingestible medical device that captures physiological parameters from within the GI tract, today announced that it has selected Cognigen Corporation (Amherst, NY) to provide clinical research organization services to the phase II 510(K) clinical trials of the SmartPill Capsule System.
In its role as Clinical Research Organization (CRO), Cognigen is responsible for monitoring clinical trials at the five participating sites; managing, validating and analyzing trial test data; and generating the clinical monitoring report that will support and facilitate SmartPill Diagnostics application to the FDA for 510(K) approval.
David Barthel, president and CEO of SmartPill Diagnostics, said, We selected Cognigen on the basis of its experience and reputation within the pharma and bio-tech industry, its team-based" collaborative approach, and because, fundamentally, Cognigen possesses the infrastructure, tools and processes that are crucial to successful clinical trials. With the addition of Cognigen, our clinical trial team is now complete and preparing for the start of phase II clinical trials in January 2005."
Cynthia A. Walawander, M.A., Executive VP of Cognigen, said, We are very excited about forming a business relationship with SmartPill Diagnostics, one of the clear leaders in the Western NY life sciences sector and a medical device developer with world-class technology. We are equally excited about the role Cognigen is playing in upcoming clinical trials of the innovative SmartPill Capsule System."
SmartPill Diagnostics also announced today that the following medical institutions have agreed to participate in clinical trials of the SmartPill Capsule System:
- Massachusetts General Hospital
- Wake Forest University
- Temple University
- University of Michigan
- The Buffalo VA Hospital
The size of a vitamin pill, the SmartPill ambulant capsule device uses patented technology to measure peristaltic pressure, temperature, pH and transit time; parameters that are expected to aid diagnosis of GI motility disorders.
About Cognigen Corporation
Cognigen is a leading provider of cognitive engineering services that reflect an innovative strategy involving three interconnected components: aggressive data management and assembly processes; innovative data analysis, modeling, and simulation activities; and effective Internet-based collaboration strategies to engage development teams in the interpretation and understanding of generated knowledge. More information on Cognigen Corporation can be found at www.cognigencorp.com.
About SmartPill Diagnostics, Inc.
SmartPill Diagnostics is a leading developer of ambulant capsule technology (ACT) that non-invasively aids diagnosis, definition and therapeutic intervention of gastrointestinal motility disorders; enhances patient comfort and convenience; and reduces the cost of exploratory examinations. The SmartPill Diagnostic System identifies criteria, heretofore unavailable, that are expected to assist Gastroenterologists and researchers in accurately diagnosing GI motility disorders, and lead to improved treatment at lower cost. Learn more at www.smartpilldiagnostics.com or call SmartPill Diagnostics at 716-855-1068.
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