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Clinical trials

Data Management

Project-specific databas

  • CRF design (paper or electronic)
  • Data management plan including annotated CRF,
    data entry guidelines, data validation plan
  • Installation, programming, validation and maintenance of study database
  • Integrated audit trail based on SQL database system
  • Continuous quality assurance

Data entry

  • Double data entry by independent personnel
  • Reconciliation of first / second data entry
  • Import of external data (e.g. Labor, EKG etc.)

Data control

  • Tracking of incoming CRF, AE / SAE check
  • Automated CRF control system
  • Medical and general plausibility check
  • Generation and processing of queries
  • SAE reconciliation
  • Final quality control, database lock

Coding

  • MedDRA, WHO-Drug, ATC, ICD-10

Data transfer

  • Data transfer, format as requested