The Casey Reading Center uses custom-designed software that allows clinical trial sites to upload and track ophthalmic images and data through a web-based interface. After data and images are uploaded, reading center personnel assess for quality, and in many cases our team of specialists provide additional analytic services. The software has built-in functionality that allows us to configure a customized process and end points for each clinical trial. The software audits transactions on the system and routes data and images through our workflow in an automated way.
Clinical trial sites and sponsors have the ability to view the progress of their own information in the system via the world wide web using a standard browser.
All trial information is deidentified and stored in our databases, which reside on enterprise-class servers at our secure data centers. The software, database and server are FDA compliant for electronic records, according to 21 CFR Part 11 and we follow the FDA guidance put forth on General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
The data centers and servers are maintained by a specialized team of information technology professionals. Data is backed up daily and stored off-site, and the servers in our data centers are protected by SSL encryption and transaction auditing.