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ImageIQ Selected As Imaging CRO For CryoLife (CRY)'s PerClot Intraoperative Hemostasis Pivotal Clinical Trial



11/3/2016 10:54:11 AM

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CLEVELAND--(BUSINESS WIRE)--ImageIQ, an innovative Imaging Software and Contract Research Organization focused on supporting preclinical research and clinical trials, announced today that it has been chosen by CryoLife to provide its full complement of clinical trial management and imaging support services and technology for a new prospective multi-center pivotal clinical trial seeking to generate safety and efficacy data for medical device IDE approval. ImageIQ’s technology and services will be utilized in support of CryoLife’s IDE study of their PerClot® Polysaccharide Hemostatic System in patients in need of adjunctive intraoperative hemostasis during open elective cardiac, general or urological surgery when control of capillary, venular, and arteriolar bleeding by pressure, ligature, and other conventional procedures is ineffective or impractical. Specifically, CryoLife will leverage ImageIQ’s EDCIQ™ imaging-enabled electronic data capture (EDC) system, customized specifically to the study’s design and workflow to support compliance with all imaging-related activities. Additionally, ImageIQ will develop and validate the imaging and image analysis protocols, procure, test and install imaging hardware, provide study site imaging qualification, training and management, and provide quantitative software-based image QA and processing prior to expert image evaluation by centralized surgical readers. Lastly, ImageIQ will also support all imaging-related data collection, transfer, storage and management.

About ImageIQ

ImageIQ, originally Cleveland Clinic’s Biomedical Imaging and Analysis Center (BIAC), is an Imaging Contract Research Organization (ICRO) providing innovative image management software, image analysis capabilities, protocol development, biomarker exploration, and clinical trial management expertise for imaging in drug and medical device clinical trials. ImageIQ combines its creative approach to problem-solving and software engineering with biomedical and imaging expertise to provide Sponsors with accelerated clinical research timelines, enhanced operational efficiencies, and imaging outcome data that is quantitative and objective. Simply put, ImageIQ’s mission is to enhance the preclinical research, clinical trial and product R&D programs of its clients by providing inventive solutions for improved outcomes. www.Image-IQ.com or @ImageIQ via Twitter

About CryoLife, Inc.

Headquartered in suburban Atlanta, Georgia, CryoLife is a leader in the manufacturing, processing, and distribution of medical devices and implantable living tissues used in cardiac surgical procedures. CryoLife markets and sells products in more than 80 countries worldwide. For additional information about CryoLife, visit our website, www.cryolife.com.

ImageIQ, Inc.
Brett Hoover, Vice President, 855-462-4347
bhoover@image-iq.com
http://www.image-iq.com


Read at BioSpace.com


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