The Casey Eye Institute TCTC 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 images are uploaded they are assessed for quality, and in some cases our team of specialists provide additional analytic services. The Reading Center software has built-in functionality that allows us to configure a customized process and end points for each clinical trial.
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 clinical trial information is deidentified and stored in our database, which resides on enterprise-class servers at our secure data center. The TCTC RC 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 center 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 center are protected by SSL encryption and transaction auditing.