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Biostatistics Scene
Safety Database and SAE Reporting

STATKING medical personnel will work with your staff to provide the following drug safety reporting services:

  • Safety Database Creation and Data Entry of Safety Data
  • SAE Narrative Writing
  • Preparation of Med Watch 3500A/CIOMS forms
  • Preparation of Periodic Safety Update Reports (PSURs)
  • Electronic Submissions of SAEs to FDA


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