Medical Imaging Management Services
A powerful proprietary image management software program for clinical trials, ClinTrak® Imaging integrates real-time central image collection, quality assurance, tracking, quantitative and qualitative analysis, data management, and image-related reporting with electronic database capture (EDC) functions; including archival of source image data. ClinTrak Imaging also supports central image collection to receive, store, and review imaging data from clinical sites, imaging facilities, and reading centers. Fully validated and 21 CFR Part 11 compliant, it maintains a full audit trail and is customized to each study to meet the specific needs of the trial.
ClinTrak Imaging readily supports a wide variety of imaging data types. Image analysis can be customized to fit the desired reading paradigm of the study, including assessments performed for inclusion/exclusion criteria, assessments conducted on an ongoing basis throughout the study to maintain quality control, and batch analysis as subjects complete the trial. All analyses can be performed in a blinded fashion based on study-specific requirements.
Technologist feedback, query generation, and reporting are built-in, so imaging centers can quickly identify and correct potential problems. ClinTrak Imaging also supports ongoing status reports so Sponsors can track the study’s progress.