ImageIQ, an innovative imaging software and Contract Research Organization (CRO) focused on supporting preclinical research and clinical trials, announced 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 used 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.