CodeAngelo® is Cliantha’s proprietary, 21 CFR Part 11, web-enabled clinical Suite with Integrated clinical solutions that seamlessly combine EDC and safety into single system.
Functionalities are designed especially to support global clinical operations and data management. The system supports simple features to configure CRF’s, coding dictionaries, and query management. CodeAngelo™ has been developed from the ground up as a truly integrated system. CodeAngelo™ allows the user to view all levels of activity with your study in real time, at all times. This unmatched level of control allows sponsors to make mid-study changes, contain costs, improve safety and increase your return on investment (ROI)
Key System Highlights
- US-FDA 21 CFR Part 11 Compliant System
- Application Program Interface (API) based modular system, ease of adding new modules
- Full-scale or modular deployment, fully configurable as per sponsor requirements
- Fully-validated with comprehensive IQ, OQ, PQ documentation
- Secure, roles-based access & authority checks Strong system authentication and security and audit trails
- Electronic signatures and records
- Ability to designate appropriate access for both site-level and study-level
- Tools for overall system monitoring
- Design tool for configuring study protocol, site, eCRF and edit checks
- Custom define and export clinical data in real time in a variety of formats.