iCRF: Advanced Electronic Data Capture
iCRF, the Aptiv Solutions Electronic Data Capture system, was specifically designed to support trials with adaptive interim analyses, including management of clinical drug supplies. The web-based system incorporates the latest technical standards in data-base technology and Internet programming.
- Seamless integration of medical coding means fast coding during study
- Query management online and offline means fast data cleaning in parallel to data entry
- Direct data access for statistician means fast statistical evaluation for interim analysis
- Validation and documentation according to GAMP 5 and 21 CFR Part 11
- Three-tiered web-based system:
- Database backend: Oracle 10g
- Application server: Apache and Tomcat Cluster
- Browser client: Internet Explorer or Firefox
- Modular architecture with defined interfaces for increased flexibility
- State-of-the-art database system: Oracle 10g
