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CORE LAB

• 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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TRAINING AND CONSULTING

• 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)

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