EXCELSIOR™ is a first-of-its kind, FDA 510(k) cleared data management system featuring cloud-based architecture designed to enhance efficiency and accuracy in the collection and interpretation of ophthalmic clinical trial data. The foundation of EyeKor, Inc., EXCELSIOR™, is HIPAA and 21 CFR part 11 compliant.
A Comprehensive, cloud-based solution
With the specific requirements in mind for facilitating an ophthalmic imaging clinical trial, the EXCELSIOR™ platform was developed as a comprehensive, cloud-based solution for data collection, site certification, workflow management, image evaluation and reporting of high-quality, objective trial endpoints. EXCELSIOR™ offers clinical trial stakeholders complete data accessibility and accountability, resulting in enhanced efficiency and accuracy for data collection and interpretation.
Built To Meet Regulatory requirements
EXCELSIOR™ is built to meet the most sophisticated regulatory controls required for modern imaging clinical trials, and is HIPAA and 21 CFR part 11 compliant. Utilizing audit trail functionality, EXCELSIOR™ tracks all access and modification of the study data. It is a first-of-its kind, FDA 510(k) cleared data management system with specific indication for use to manage ophthalmic clinical trials.
unparalleled service coupled with advanced technology
EyeKor provides the team, the technology and the ophthalmology expertise to manage your ophthalmology imaging studies, from early Phase 1 project when availability to data and images is essential, to large global phase III project when real-time progress and status reporting is paramount. The combination of advanced technology and exceptional service is key to optimizing your imaging strategy and ensuring trial success.