Data Management

High-quality and professional data management is becoming increasingly important due to the growing awareness of quality control and quality assurance in clinical research.   

Good and reproducible results from statistical analyses can only be achieved with a high-quality database.  

What we offer

  • Data collection
    • Paper case report forms (CRFs)
    • Electronic case report forms (eCRFs) according to EMA Guidelines and FDA 21- Part 11
  • Preparation of the “Data Management Plan” (DMP)
  • Creation of the “Data Validation Plan” (DVP)
  • Database creation (Excel or Stata incl. audit trail)
  • Data entry (double or single)/ data import
  • Data query management
  • Plausibility check and quality control of the database
  • SAE reconciliation