New York, NY – Developers at EyeKor, LLC, have introduced real-time reporting of key clinical trial performance metrics in EXCELSIOR™, the company’s clinical trial data management and image analysis software.
EXCELSIOR™, an FDA 510(k)-cleared application, is a cloud-based platform specifically designed for ophthalmic clinical trial management. EXCELSIOR™ is focused on providing investigators, clinical trial sponsors, and clinical research organizations with secure, real-time access to trial data, and enhancing efficiency, accuracy, and transparency in data and diagnostic image collection and analysis.
The new reporting function allows the users to track trial progress and reading center performance against several key performance metrics defined by the Metrics Champion Consortium (MCC), allowing sponsors to gain real-time insight on reading center services, processes, and ability to meet critical timelines.
“The EXCELSIOR™ Performance Metrics report provides a comprehensive snapshot of a clinical trial’s progress and reading center performance,” says Yijun Huang, PhD, of EyeKor. The summary report highlights three key areas of clinical trial performance:
· Recruitment progress: technician and equipment certification, subject enrollment, and data collection progress
· Reading center performance: turnaround time and timeliness of data quality check and grading steps, tabulated for all visits and for the eligibility visit separately
· Clinical sites’ performance: overall quality of data submissions, turnaround time and timeliness for uploading data, and query metrics (number of queries and average turnaround time of resolution)
Automatically generated to reflect real-time status, the EXCELSIOR™ MCC-standard report includes graphical representations of key statistics and can be saved and shared with trial stakeholders in a variety of file formats.
“Adding this key metrics reporting capability underlines EyeKor’s commitment to secure, efficient, and standardized information access, and to providing the highest standard in reading center services for ophthalmic clinical trials;” says Luca Sergio, Managing Partner of Ethis HealthTech, “it will enable more effective decision making and greater peace of mind for clinical trial managers and stakeholders.”
EyeKor, LLC, is a network of established reading centers and ophthalmic clinical trial experts that offers a complete spectrum of integrated ophthalmic clinical trial services. EyeKor experts are unified through common standard operating procedures, quality control and assurance, regulatory compliance, and computing infrastructure. EyeKor’s expertise encompasses a diverse array of ophthalmic testing methods including fundus photography and angiography, optical coherence tomography, slit-lamp photography, fundus autofluorescence imaging, automated visual field testing, and electrophysiological testing.
Managing Partner, Ethis HealthTech