Dr. Jonathan Goldman MD, Chief Medical Officer at ICON Medical Imaging, and a recognised expert in echocardiography commented: MIRA-ECHO satisfies an important unmet need in clinical trials that involve ECHO. For the first time we have a solution that allows us to adjust and fine-tune traced cardiac measurements stored in the eCRF against a moving source image, whilst maintaining regulatory compliance and an audit trail. Combining MIRA-ECHO to the existing MIRA-QCA module for quantitative coronary angiography allows us to offer clients unparalleled capabilities for cardiovascular assessments.
ECHO is a widely used clinical method for assessment of heart structure and function. It is playing an increasingly important role in clinical trials as both a marker of cardiac safety and as a measurement of the therapeutic effects of drugs and devices being evaluated in patients with heart failure. Currently available ECHO software is limited by the inability of the interpreting physician to fine-tune tracings of measurements of the borders of the heart wall against the full motion image of the heart. This fine-tuning can optimise the accuracy of an important marker of heart performance – the left ventricular ejection fraction.
MIRA-ECHO is a digital DICOM (Digital Imaging and Communications in Medicine) image viewer and analysis software module that is integrated with an eCRF (Electronic Case Report Form). It displays links from the traced images back to the measured moving heart image, and also to the numerical measurements captured in the eCRF. Functionality embedded within the eCRF allows a physician to adjust preliminary measurements, while maintaining compliance with 21 CFR Part 11 regulations. MIRA-ECHO also enables measurement and assessment of the full complement of ECHO parameters.
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 http://www.iconmedicalimaging.com
About ICON plc
ICON plc is a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries. The company specializes in the strategic development, management and analysis of programs that support clinical development – from compound selection to Phase I-IV clinical studies. ICON teams have successfully conducted over 5500 development projects and consultancy engagements across all major therapeutic areas. ICON currently has over 6500 employees, operating from 71 locations in 38 countries.
Further information is available at http://www.iconplc.com