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  • 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 site 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.
  • Tracking and quality control/assessment of image data.
    • Information available to Sponsor in real time by secure web access 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.
  • Complete audit trail.
  • Secure server back-up for all images and image analysis data.

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  • Consultation.
    • Study Design, Imaging Protocol Development or Review, Imaging Biomarkers, Clinical Trial Management, Imaging Manual, etc.
    • Sequence Imaging assessment.
    • Image response assessment.
  • Training
    • General training in imaging techniques (addressed to CRAs, SC and general audience).
    • Project Specitic Training (imaging endopoints).
    • Image response criteria (addressed to CRAs, SC and general audience)