CDMmanager: Paper-based CDMS System
CDMmanager©, our paper based CDMS system supports all
requirements Sponsors and CROs may need to complete paper-based
studies with results comparable to those achieved by EDC
systems. CDMmanager© incorporates SCiAN's 25 years
of experience in managing drug development phase I-III
clinical trials as well as phase IV trials.
Core functionality
- FDA 21 CFR Part 11 compliant
- Integrated CRF and DCF tracking module
- Page-level definition for single or double entry
- Supports "heads-down" double data entry
- System-enforced sequencing of steps / implementation of
data management SOPs
- Access control to enforce s for data entry and data entry error
correction
- Symbolic language for comprehensive (across-forms) data
validation / edit checks
- Query generation, routing, resolution for all different
distribution of responsibilities
- Modules for coding, SAE reconciliation and medical/science
review
- Comprehensive status reporting
- Document management systems
- Data export into SAS analysis data sets.