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Imaging Core Lab Services
Medical Imaging Core Laboratory | Services


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GENERAL CAPABILITIES




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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