High-Quality Imaging and Site Compliance
MMI verifies the ability of each study site to support the imaging requirements of the trial. Based on the study-specific imaging protocol, we evaluate each site’s equipment, infrastructure, and personnel to verify that the site can reliably acquire the required imaging and ensure smooth transfer of images to our facility for centralized review. We provide detailed guidance and hands-on training to assure the highest level of image quality and processing. All training materials are comprehensive, user-friendly, and professional.
Our procedures for site qualification and training include:
- Comprehensive equipment testing and calibration.
- Detailed inspection and verification of the acquisition and storage systems.
- Printing and distribution of study-specific protocols and ancillary material.
- Didactic training on the imaging protocol and frequently asked questions.
- Distibution and training on calibration markers and imaging phantoms.
- Evaluation and verification of test images produced per the imaging protocol.
- Development of site- and equipment-specific quality assurance (QA) procedures.
- Instruction on QA phantom setup, scan acquisition, and analysis of QA scans.
- Verification of image transfer procedures and data query process.
Site Compliance Monitoring and Maintenance
Following initial site training, we perform ongoing monitoring to assure compliance to the imaging protocol. Each shipment of images is carefully inspected for adherence to documented standards for subject preparation, image acquisition, image quality, image labeling, transfer, management, and completion of transmittal information. Where appropriate, sites are promptly notified of protocol deviations, and corrective action is implemented. As needed, we travel to sites to verify equipment calibration, processes, and training. Additionally, we provide on-demand technical and logistical support for study-related questions.