Study-preparation:

  • calculation of sample size
  • preparation of the statistical part of protocols
  • overall, pooled analysis of existing (historic) data for new hypotheses

Study-analysis:

  • design of data entry screens (SAS, OpenClinica, MS Access, build-in automated checks)
  • data base design
  • Randomisation/Code Breaking Logistic
  • single/double data entry (SAS, OpenClinica, MS Access), data-verification
  • coding (diseases usually according to MedDRA), WHO-ART drugs usually according to WHO Drug Reference List, WHO-ATC, or according to special codes of the client)
  • automated, computer supported generation of queries/data clarification forms for monitors and investigators
  • data validation/consistency/logical checks, data cleaning
  • checks for protocol violations, checks for reliability of data
  • statistical programming/analysis
  • statistical report
  • data quality report (on demand)
  • meta-analysis
  • development of statistical analysis plan
  • CDISC Standard: eg. CDASH, SDTM, ADaM, ODM, define.xml

Software development:

  • customer's tailored data base, e.g. for adverse events (regulatory purposes)