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
