We work extensively with our customers and the regulatory bodies to make sure nQuery always meets regulatory requirements and guidelines.

nQuery is used at the following regulatory agencies:

  • FDA
  • EMA
  • PMDA

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  • nQuery was specifically developed with FDA approval in mind. The Statement Generator automatically uses regulatory approved syntax and language.
  • nQuery is used extensively at the FDA by regulatory statisticians during the trial review process
  • Over 200 FDA-based statisticians use and trust nQuery 
  • FDA reviewers regularly correspond with us for training and software enhancements. We recently provided training for up to a 100 statisticians.

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I have been a user of nQuery software since the late 90's for sample size calculations in clinical trials, and for the last 14 years nQuery has been a standard product in the Boehringer-Ingelheim toolkit

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Andy Lawton, Boehringer Ingelheim

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