SMARTSTATS

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.

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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.

Features

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>>

Request a Demo
Demo Version
Software Login

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