Ophthalmology Imaging

Ophthalmology Imaging

Top Ophthalmology Imaging CRO

  • Board-certified ophthalmologists, retinal specialists, and imaging analysts providing high quality, standardized, and reproducible interpretations of ocular images, for rapid and reliable image assessments to support clinical research study endpoints
  • Long-standing relationship and collaboration with ophthalmic imaging KOLs/SMEs within an extensive reader network for expert support with various modalities of ophthalmic imaging
  • Imaging analysts with a widespread knowledge in qualifying sites with customized and advanced ophthalmic imaging acquisition protocols
  • In-depth understanding of the various ophthalmic evaluation techniques available for the required study assessments, and their respective advantages/disadvantages
  • Cohesive study team with experience utilizing ophthalmic imaging in clinical trials to monitor disease progression in support of study efficacy and safety objectives among large, global patient populations

Streamlined Process

  • Harmonization of image acquisition protocol across global sites to successfully assess the study-specific objectives
  • Imaging Review Charter and other manuals documenting standard procedures used for clinical trials
  • 24/7 global site management
  • Compliance with GCP, GDPR, HIPAA requirements and alignment with QIBA profiles, FDA guidance, and Metrics Champion Consortium (MCC)

Integrated Technology

  • Validated analytical workstations dedicated to data analysis
  • Cloud-based image transmission system with zero local IT footprint (ClinTrak® Imaging); seamless integration with other study-related services through ClinTrak®
  • Real-time visualization of all images as well as customized metrics and KPIs remotely for audits/inspections
  • Advanced data mining in support of trials with disease assessment endpoints

Expert Quality

  • Rigorous quality control and validation process
  • Dedicated imaging QA officers
  • Standard Operating Procedure (SOP) driven process
  • Successful 2019 FDA Inspection with no findings
  • CFR Part 11 compliant and fully validated imaging system for clinical trials

Modalities

  • Color Fundus Photography
  • Optical Coherence Tomography (OCT)
  • Optical Coherence Tomography Angiography (OCTA)
  • Fundus Auto-fluorescence (FAF)
  • Fluorescein Angiography (FA)
  • Indocyanine Green Angiography (ICG)
  • RetCam
  • Electrophysiology
    • Full Field ERG
    • Multifocal ERG
  • Humphrey Visual Field (HVF)
  • B-Scan Ultrasonography
  • Slit Lamp Photography
  • Anterior Segment Optical Coherence Tomography (OCT)
  • Corneal Topography
  • Specular Microscopy
    • Endothelial Cell Count
    • Hexagonality
    • Coefficient of Variation
  • Confocal Microscopy
    • Corneal/Scleral
    • Lids/Lashes
  • Volumetric Measurements
    • Densitometry
    • Pachymetry