Biostatistics Scene
Drug Safety Reporting

STATKING medical personnel work to ease the burden of medical monitoring for your internal staff by providing 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


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

 
 
©2005-2006 STATKING Consulting, Inc.