EyeKor provides reading center services for ophthalmic imaging, visual function testing, and electrophysiological testing. At the sponsor’s discretion, the image reading can be performed by a reading center of the sponsor’s choice, or by trained EyeKor staff. Multi-step grading is built into EXCELSIOR™, providing users the ability to adjudicate discrepant or questionable features on the image and provide a single grading result. Any patient’s images can be viewed side by side across all time points and imaging methods, enabling easy evaluation of changes to the eye as the trial progresses. The Imaging Charter, created during the start-up phase, includes the quality control plan, whereby reproducibility of reading center assessments can be documented and monitored over the course of the trial. EXCELSIOR™ can be configured to any reading center work flow to accommodate quality control, e.g., masked regrading of a desired percentage of submissions.
EyeKor graders are trained in accordance with EyeKor’s SOPs and evaluation procedures. Reader Certifications are issued upon successful completion of the required training and testing modules. Inter- and Intra-grader variability are assessed periodically to monitor reader performance as a group and individually.
EXCELSIOR’s™ integrated query system further enhances our ability to track issues with imaging submissions and alerts the appropriate study personnel to issues that need resolution. Additional quality control mechanisms are implemented to identify outliers in the data or longitudinal inconsistencies for a subject or data type.