Site Qualification
The key to any imaging trial is the ability of the imaging sites to deliver consistent quality images for analysis. To ensure our high standards are met we conduct a 3-step site qualification process assessing each potential site on their equipment and personnel as well as their likelihood to remain in compliance and adhere to timelines throughout the life of the study. Our site team utilizes a proprietary software tracking system, SMART (Site Management Automated Reports and Tracking), in order to accelerate imaging site qualification and initiation in an effort to shorten the project start up phase.
Our site Pre-Qualification consists of a survey of each potential site to gather the following information:
- Equipment type and make
- Field strength
- Gradient strength
- Coil availability
- Personnel qualifications
- Data Transfer capability
Qualifying sites will then pass into the Initial Qualification stage where remote training will be conducted and sites will submit phantom and/or volunteer scans for review. These scans will help us assess both the system and overall site capabilities. Sites must pass the Initial Qualification stage prior to scanning of the first subject.
Once the first subject is scanned, the data set is sent to VirtualScopics for quality inspection and analysis. This constitutes Final Qualification making the site ready to accept and scan further subjects.