If you are involved with a clinical trial for an ophthalmic product, you’re likely capturing and analyzing image data as part of your study. Which brings up a problem: Collection and interpretation of image data is one of the most challenging aspects of a clinical trial, and it becomes exponentially more difficult when different devices (often from different manufacturers) are used by different people at different sites. Standardizing the data format and analysis across image types and manufacturers is critical element for data interpretation for clinical trials
EXCELSIOR™ image management software provides a solution for the most daunting problems in the field. Developed by EyeKor LLC, this unique software platform harmonizes the data from different imaging modalities using the internationally recognized DICOM (Digital Imaging and COmmunications in Medicine) standards. Data standardization is performed by EyeKor's data quality evaluators who provide quality control.
"Data quality control and harmonization is the first and most essential step in clinical trial data evaluation," says Ronald P. Danis, MD, Chief Scientific Officer, EyeKor. "Good data ensures the rigor of the study outcome. EyeKor meticulously approaches this, so that good quality data can be viewed, graded, and analyzed in a single, web-based platform. This functionality, among many others, uniquely positions EXCELSIOR™ to harnessing the expertise of multiple reading centers with a broad range of functionalities."
EXCELSIOR™ has received FDA 510k clearance as a class 2 medical device indicated for managing ophthalmic clinical trial data. Interested in learning more about the exceptional EXCELSIOR™ software for ophthalmic clinical trial management? Contact Luca Sergio: (212) 791-1440