SmartPill Diagnostics Selects Cognigen to Provide Clinical Research Organization Services to SmartPill Capsule Clinical Trials
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 Diagnostic’s
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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Source : http://www.prweb.com/releases/2004/12/prweb184861.htm