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.