A powerful proprietary image management software program for clinical trials, ClinTrak® Imaging integrates real-time central image tracking, quantitative and qualitative analysis, data management, and image-related reporting. ClinTrak Imaging also supports central image collection to receive, store, and review image data from clinical sites, imaging facilities, and reading centers. Fully validated and 21 CFR Part 11 compliant, ClinTrak Imaging maintains a full audit and is customized to each to study to meet the specific needs of the trial.
Whatever the study, ClinTrak® Imaging readily supports a wide variety of imaging data types. This platform also supports image analysis, which can be customized to fit the desired reading paradigm of the study. These include assessments performed for inclusion/exclusion criteria, assessments performed on an ongoing basis throughout the study to maintain quality control, as well as batch analyses 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 any potential problems. ClinTrak® Imaging also supports ongoing status reports so sponsors can track the progress of the study.
- Secure electronic image uploader supporting all file types with zero local footprint
- Automated tools for:
- Imaging anonymization and pixel data masking
- DICOM tag extraction
- Medidata comparisons across image data sets
- Safe archival received images
Image viewing capabilities
- Built-in DICOM viewer for quality control or analysis
- Web based environment that can allow images to be viewed- by any member of the study team, including Sponsor, Data Safety Monitoring Boards (DSMB), etc. Complete integration with several image analysis software programs that allows automatic capture of image data, convenient for central reviewers
Independent reader module
- Implementation of study specific assessment criteria for use by the Imaging Core Lab reader or other Sponsor identified reader.
- Remote access enabled to support remote reads without issue
- Ability to program various central review workflows including single read or multiple read plus adjudicator paradigms
Central Reporting Capabilities
- Subject Scan Reports
- Customizable to fit study-specific needs of reporting imaging findings to study sites and Sponsor
- Site-specific reports include
- Quality feedback
- Subject management decisions
- Technologist-specific reports provide ongoing feedback for image optimization.
- Site Personnel and Study Contacts Warehouse
- Capture site communications and outreach
- Technologist Oversight
- Training, credentials, certification, and re-certification tracking
- Monitoring of technologist performance for received images
- Start up and Qualification tracking
- Sponsor access provides
- Real-time visualization of imaging data
- Subject status tracking
- Study-specific report
- Site access provides
- Easy access to study documents
- Imaging resources specific to the study