Clinical Data as a Service (CDaS) by Caresyntax offers a comprehensive suite of technology and professional services designed to collect and analyze real-world evidence (RWE) generated during the normal course of patient treatment within surgical processes. This service leverages a proven Clinical Quality Improvement (CQI) methodology to gather data and provide analyses that drive value-based quality improvement initiatives. CDaS enables industry partners to analyze de-identified RWE and real-world data (RWD) concerning their products' usage in operating rooms across the US and EU, acting as a data analytics engine for both clinical and industry partners by managing the burdens of data collection, cleansing, analysis, and reporting. The outputs are tailored to partner needs, ranging from data analytics and reports to white papers, presentations, publications, and regulatory submissions. The CDaaS CQI method is FDA-validated and can be conducted without requiring Institutional Review Board (IRB) submission or individual patient consent, as it does not meet the criteria for research on human subjects. Data captured can include clinical data from electronic medical records, imaging, video, medical devices, direct patient follow-up, and hospital financial data, all customized to project needs. Projects are significantly faster than traditional clinical trials, delivering actionable insights in months rather than years, and can be deployed anywhere a partner's product is in use. Caresyntax ensures compliance with regulations like GDPR and HIPAA.

Features & Benefits

• Real-World Evidence Collection: Collects and analyzes data generated during standard patient care processes.
• Clinical Quality Improvement (CQI) Methodology: Integrates clinical teams and uses iterative cycles to identify true measures impacting value and outcomes.