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ICON Delivers New Electronic Solution to Expedite Clinical Trial Adjudication
Date:1/26/2009

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ICON's new endpoint solution is a fully validated module of the existing MIRA(TM) (Medical Imaging Review and Analysis) technology platform, developed and managed by ICON Medical Imaging. MIRA is a proprietary 21 C.F.R. Part 11 compliant system that provides functionality for imaging and clinical data management, image analysis, project management and document management. The new endpoint module stores all data relevant to the adjudication of cardiovascular events - including Case Report Form (CRF) output, patient charts, laboratory results, ECG, echocardiogram, Multi-Gated Acquisition Scan (MUGA), coronary angiogram, peripheral angiogram and x-rays - in a digital DICOM (Digital Imaging and Communications in Medicine) format. Adjudicators in different locations can simultaneously access and review this data in a secure online environment and complete the assessment in an electronic CRF. The CRF is logic driven and can also allow for queries for extra data as well as programmatic identification of cases that require consensus resolution.

Dr. Didier Saur, MD, Vice President, Endocrinology & Metabolism at ICON Clinical Research added: "This latest regulatory requirement will make the clinical development of diabetes drugs more demanding in terms of patient exposure and inclusion of patients at a higher cardiovascular risk. Companies developing oral anti-diabetic drugs can not only benefit from ICON's new technology solution but also from the vast experience of ICON's diabetes and cardiology specialists as well as the expertise of our Cardiac Scientific Advisory Board."

About ICON Medical Imaging

Located in Warrington, PA, ICON Medical Imaging, a division of ICON plc, is the leading provider of Medical Imaging core laboratory services to pharmaceutical, biotech and life science clients globally. The team's extensive experience and expert guidance enables clients to maximise the suc
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SOURCE ICON plc
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