Your focus: statistical report writing

SMARTSTATS is an umbrella software consisting of modules that facilitate report writing in line with all kinds of guidelines and authority (EMA/FDA/MHLW/…) expectations.

Value for you

  • Standardize reporting across the organisation 
  • Up-to-date with latest authority requirements (EMA, FDA, …)
  • Suitable for GxP use (GAMP5 validated, 21 CRF Part 11 compliant)
  • SaaS: no maintenance cost for you (i.e. we maintain it for you)
  • Save cost and time in report writing 
  • Significantly reduce human errors
  • Go further than Excel (e.g. REML, quantile computation, etc.) to always give exact statistical results
  • Easy to use: made by statisticians for non-statisticians
  • Best-in-class decision making

Our statisticians provide support for any questions concerning the use of the software and the processing of your data.


Generate eCTD reports in compliance with authority expectations:

  • Enoval: module for analytical method validation (physico-chemical) in line with ICH Q2(R2).
  • Seelva: module for bioassay validation in line with ICH Q2(R2) and USP 1033.
  • More to come…

SMARTSTATS – the details

Contact us to request a demo or check our demo version with the links below>>

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