Data Handling, Analysing


Data Management

  • Data management plan
  • Data base design
  • Data input according demands (double, electronically etc.)
  • Data cleaning systems (query, online etc.)
  • Coding (MedDRA®, ICD 10 etc.)
  • Audit trail documentation
  • Remote data capture / eCRF in cooperation with established partnerships

Biostatistics

  • Biostatistical planning and consulting
  • Sample size calculation
  • Randomization procedures
  • Analyses plans
  • Interim analyses
  • Adaptive design planning
  • Organization of IDMC (Independent Data Monitoring Committee)
  • Biostatistical evaluations with SAS® and other software
  • Statistical report

Medical Writing of

  • Reports
  • Publication manuscripts

Managing and Monitoring Quality Management