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Non-interventional studies

Data Management

Project-specific database

  • CRF design (paper or eCRF)
  • Preparation of annotated CRF, data entry guidelines, data validation plan
  • TeleForm-Scanning-System
  • Installation, programming, validation and maintenance of database, online / offline
  • Continuous quality assurance

Data entry

  • Registration of participants
  • Data capture by manual entry, electronic scanning or online
  • Import of external data

Data control

  • Tracking of incoming CRF, supervision of AE / SAE
  • Data review
  • Check of condition to allow remuneration
  • Plausibility control and query generation
  • SAE reconciliation

Coding

  • MedDRA, WHO-Drug, ATC, ICD-10

Data transfer

  • Data transfer, format as requested