Ophthalmology
Ophthalmic Reading Center
We are the leader in retinal imaging evaluation services for multinational studies.
Key highlights of our ophthalmic-focused team include:
– 23+ year history of conducting programs for ocular therapeutics as well as monitoring of ophthalmic safety for systemic treatments
– Successful completion of over 100 ophthalmology trials
– Expertise in managing screening studies with expedited results
– 1.5+ million ocular images analyzed
– Experience in delivering clinical trial data to regulatory authorities
– In-house, full-time ophthalmologists ready to read for your next study
WorldCare Clinical and DARC (Digital Angiography Reading Center) have been one company since 2021. Since 1998, DARC Ophthalmic & Ophthalmology Reading Center has been the world leader in retinal imaging evaluation services for multinational studies.
Ophthalmology Central Reviews
We have experience across modalities, including:
- Color Fundus Photography
- Optical Coherence Tomography (OCT)
- Optical Coherence Tomography Angiography (OCTA)
- Fundus Auto-fluorescence (FAF)
- Fluorescein Angiography (FA)
- Indocyanine Green Angiography (ICG)
- Fundus Photography
- RetCam
- Electrophysiology
- Full Field ERG
- Multifocal ERG
- Confocal Microscopy
- Corneal/Scleral
- Lids/Lashes
- Specular Microscopy
- Endothelial Cell Count
- Hexagonality
- Coefficient of Variation
- Volumetric Measurements
- Densitometry
- Pachymetry
- Corneal Topography
- Humphrey Visual Field (HVF)
- B-Scan Ultrasonography
- Slit Lamp Photography
- Anterior Segment Optical Coherence Tomography (OCT)
- Multifocal And Full Field Electro Retinography
- Microperimetry
- Visual Field Interpretation
- Anterior Segment Photographs, OCTs, And Ultrasound
Read Team
Our dedicated team of ophthalmologists, technicians, regulatory experts, and project managers is among the most knowledgeable and well-respected in the industry. Our services also include safety monitoring. Experts work with sponsors to design trials which ensure high-quality results in a cost-effective manner. We collaborate with sponsors in workflow design and imaging charter development to establish the foundation necessary to meet the sponsor’s clinical trial goals.Reader Training
Through a combination of our expert ophthalmologists and our rigorous training and testing regimen, we are committed to increasing the accuracy and precision of data subject to blinded independent central review.
Study Design
Our experts work with sponsors to design trials which ensure high-quality results in a cost-effective manner. We collaborate with sponsors in workflow design and imaging charter development to establish the foundation necessary to meet the sponsor’s clinical trial goals.
Web-Based Technology Platform
Our state-of-the-art systems are 21 CRF Part 11 compliant and are used to analyze images from all modalities. The systems can be accessed by ophthalmologists to perform assessments anywhere in the world. Thousands of clinical sites in the U.S., Latin America, Europe, and Asia-Pacific have uploaded imaging data directly into our secure system.
Regulatory Experience
We have an extensive history in preparing submissions for regulatory approval by the U.S. Food and Drug Administration (FDA) Medical Imaging Division and the European Medicines Agency (EMA). Our Quality Management System is designed to provide the structure and controls required to support execution of the clinical study, while ensuring that processes meet current regulatory standards.