Biostatistics Scene
Medical Monitoring

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)
  • Preparation of Periodic Adverse Event Experience Reports (PADERs)
  • Notification of potential expedited IND, alert and suspected unexpected serious adverse reactions
  • SAE reconciliation
  • Safety Monitoring Plan Development


 
Biostatistics Statistical Programming Clinical Trial Management Clinical Project Management Clinical Data Management Clinical Study Monitoring Medical Writing

 
 
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