We provide clean, scientific databases and validated statistical analysis.

Our service includes a final study report compliant with the regulatory guidelines,.

To serve our clients’ data management needs efficiently and cost effectively, CDMS has established a data management team based in Vienna (Austria) using validated software and computer systems compliant with ICH-GCP, EMEA and FDA standards.

  • Design of Data Management Plan including data management section in the study protocol
  • Database design with database definition, security and Data entry screens
  • Design of Data Validation Plan
  • Data Entry with by demand ongoing data, entry (single or double entry)
  • Medical/Science Review (consistency of data)
  • SAE Reconciliation
  • Medical Coding (adverse events and concomitant drugs)
  • Data Validation and Query Management
  • Database Lock and Audit (interim and final) with associated documentation
  • Database Documentation in defined formats (ASCII, SAS etc.)
  • Design of statistical analysis plan
  • Performing interim and final analyses
  • Presentation of results from the statistical analysis
  • Data analysis plus data listing
  • Statistical report writing
  • Final study report writing
  • Medical writing (publication manuscripts, preparation of presentations)