OpenClinica is powerful, industry leading software for capturing and managing clinical trial data.
- Create your own studies
- Design electronic Case Report Forms (eCRFs)
- Supports GCP (Good Clinical Practice) and CFR Part 11
- Open-source architecture and source code (J2EE). Modular architecture incorporating web services for extensibility.
- 100% web-based
- Dynamic generation of web-based CRFs for electronic data capture via user-defined clinical parameters and validation logic specified in portable spreadsheet templates and rules.
- Management of longitudinal data for complex and recurring patient visits. Automated and manual capabilities for import, export, and interchange of captured clinical data with other systems.
- Extensive interfaces for data query and retrieval across subjects, time, and clinical parameters, with dataset export in common file formats.
- Role-based access control
- Password and user authentication security
- Electronic signatures and certificates
- SSL encryption
- De-identification of Protected Health Information (PHI)
- Comprehensive usage auditing to record and monitor access and data changes