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ICOSpeedRead Overview - ICON plc

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Technology <strong>Overview</strong><br />

<strong>ICOSpeedRead</strong> TM<br />

Medical Imaging<br />

Excellence in<br />

Medical Imaging Technology<br />

Transforming images into information.<br />

Turning information into knowledge.<br />

Mapping Life Pixel by Pixel. TM<br />

<strong>ICON</strong> Medical Imaging has created <strong>ICOSpeedRead</strong>, a Independent Image Review<br />

System, that incorporates RECIST (1.0 and 1.1) criteria to quickly get the image review<br />

process up and running. The system allows protocol specific configuration and allows <strong>ICON</strong><br />

Medical Imaging to begin reading in as little as two (2) weeks. No other competitor offers<br />

these components, in this time frame, with this level of quality.<br />

<strong>ICOSpeedRead</strong> consists of a complete, validated, package including:<br />

• An Independent Image Review Charter<br />

• RECIST based eCRF linked directly to our image management and analysis system<br />

• 24/7 live reporting from the system to keep the team informed of each subject’s status<br />

• A comprehensive, image enabled, outcomes based database for internal use or delivery<br />

to regulatory authorities.<br />

All components have been completely validated and comply with GCP and 21 CFR Part 11,<br />

including complete audit trail tracking. The system has been sent to the FDA and currently is<br />

in use for recent oncology submissions.<br />

To learn more about <strong>ICON</strong> Medical Imaging’s <strong>ICOSpeedRead</strong> TM technology,<br />

please contact us for a personalized demonstration.<br />

www.icon<strong>plc</strong>.com


Technology <strong>Overview</strong><br />

<strong>ICOSpeedRead</strong> TM<br />

Medical Imaging<br />

Full compliance with RECIST protocols<br />

Derived Responses<br />

Error Checking,<br />

and complete audit trails.<br />

21 CFR Part 11 Compliant,<br />

For more information, please contact:<br />

<strong>ICON</strong> Medical Imaging <strong>ICON</strong> Medical Imaging AG<br />

2800 Kelly Road, Suite 200 Zeltweg 46<br />

Warrington, PA 18976 CH-8032 Zurich<br />

United States of America Switzerland<br />

www.icon<strong>plc</strong>.com<br />

Tel: +1 267 482 6300<br />

Fax: +1 267 482 6301<br />

Email: imaging@icon<strong>plc</strong>.com<br />

Tel: +41 44 582 41 00<br />

Fax: +41 44 582 41 01

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