GENERAL CAPABILITIES

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Related Information

Downloads and Links

• Fact Sheet: Imaging Core Lab Summary (PDF)

Full Service Study Design and Management

• Design and implementation of centralized independent review/analysis of images
• Defined in the Imaging Review Charter
• Design of imaging related eCRFs for the central image QA/read/analysis results
• Creation of database for image analysis results
• Data management of imaging results (ClinTrak Imaging)
• Efficient transmittal and analysis of images allows rapid turn–-around for time-sensitive imaging components, such as those for eligibility safety
• Experienced at performing IMT as a measure of atherosclerosis progression.
• Data transfer specification document, and data transfers
• Statistical analysis of imaging results
• Generation of report for imaging component of study
• Seamless integration with other study-related services such as IVRS, web-based reporting, and study management
• Seamless database integration with clinical database
• Regulatory submission preparation

Medpace ICL Services

• Consultation on imaging biomarker strategy for clinical development plans across therapeutic areas
• Preparation of and recommendations for the imaging-related components of the clinical trial protocol, ICFs, and CRFs
• Coordination with Sponsor/clinical CRO on global site selection to ensure that sites have access to imaging capabilities needed for the trial
• Evaluation of on-site equipment
• Identification of qualified on-site imaging staff
• Site qualification to confirm imaging quality prior to trial subject scanning
• Imaging Review Charter to define imaging acquisition, data management, and image analysis procedures
• Standardization of image acquisition protocol across global sites
• Study specific training of staff
• Site imaging technical manual
• On-site or web-based training (multilingual)
• Training of clinical trial CRAs in imaging components of trial
• Centralized collection and archival of images from sites globally via web to ICL servers or courier to office
• Tracking and quality control/assessment of image data
• Information available to Sponsor in real time by secure web access using our ClinTrak® Imaging system
• Images processed and archived by Image Analysts and Project Assistants trained in a uniform manner, following ICL SOPs
• QC/QA checks
• Proper image de-identification and adherence to imaging protocol
• Real-time feedback to sites on quality issues
• Utilizes ClinTrak Imaging
• Proprietary 21 CFR Part 11 compliant software
• Complete audit trail
• Secure server back-up for all images and image analysis data