SERVICES

Clinical Studies (Phase I- Phase IV)

  • Site and investigator selection
  • Ethics Committee and Ministry of Health applications
  • Site Coordinator support
  • Site initiation, monitorization and close-down visits
  • CRF / e-CRF preparation
  • IVRS, IWRS preparation

Data Management and Statistics

  • Validation
  • Database preparation
  • Data entry
  • Data management
  • Sample size calculation
  • Randomization
  • Statistical analysis plan
  • Statistical interim analysis
  • Statistical final analysis

Medical Writing

  • Protocol writing
  • CRF / e-CRF design
  • Clinical study report
  • Full article
  • Poster

Training

  • Investigator Meeting
  • Monitor and Investigator training
  • Good Clinical Practices and current legislation training
  • CRA school


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