Dublin, Ireland, August 11th, 2008 – ICON plc (NASDAQ: ICLR; ISIN:IE0005711209), a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced that its Medical Imaging division has become the first commercial imaging core laboratory to offer Quantitative Coronary Angiographic (QCA) analysis with an integrated electronic Case Report Form (eCRF).
This new service has been made possible through the integration of QCAPlus, a leading QCA application from Sanders Data Systems, with an eCRF within ICON Medical Imaging’s proprietary Medical Image Review and Analysis (MIRA™) system. The integration of QCAPlus adds to the existing visualisation, analysis and project management applications currently available through MIRA™.
“Clinical trials incorporating QCA have made a significant impact in cardiovascular drug and device development,” commented Jonathan Goldman MD, Chief Medical Officer, ICON Medical Imaging. “Building QCA capabilities into MIRA™ represents the latest in a series of innovations designed to boost the integrity and reproducibility of clinical trial data, and enhances our leadership in the field of imaging within clinical research.”
Coronary angiography is the gold standard for the diagnosis of obstructive coronary artery disease. The use of quantitative analysis for angiographic interpretation in clinical studies reduces variability and enables findings to be statistically categorised, leading to more reliable study results. The complexity of capturing angiographic analyses in a clinical trials database inspired the integration of QCAPlus with ICON’s MIRA™ system. The new integrated system enables quantitative measurements and qualitative interpretations to be captured in a single electronic case report form in a fully 21 CFR Part 11 compliant environment.
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 success of their medical imaging endpoints, supporting their current research and development capabilities. ICON Medical Imaging has managed over 260 imaging trials in oncology, cardiovascular, CNS, medical devices and imaging agents.
Further information is available at www.iconmedicalimaging.com