Electronic Data Capture (EDC)
We offer a fully validated online system to capture
case report forms (CRFs).
We provide you with easy-to-use, intuitive, fully validated, FDA 21CFR part 11-compliant Electronic Data Capture (EDC) system based on OpenClinica Enterprise ® Edition >.
- Hosting of OpenClinica ® Enterprise Edition on our own servers
- eCRF development based on study protocol (incl. validation)
- CRF export for paper based data capture
- Web based interface for data entry
- User account management with various roles and tailored views/screens
- Medical coding (ATC/DDD, MedDRA)
- EDC user training (offline and online)
- Data validation (edit checks and rules incl. validation)
- Full audit trail