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).
  • More to come…

SMARTSTATS – the details

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

Contact Us

Contact Form

Complete this form to stay in contact with us.

Global Approach

PharmaLex has 60+ offices in 32 countries serving more than 1600 satisfied clients worldwide. Search your nearest office.

Scroll to Top

Suspicious Emails

We are aware of a number of suspicious emails about recruitment in circulation purporting to be from PharmaLex. Emails sent by PharmaLex will originate from Should you receive an email and are unsure as to its validity, please report it to

Many thanks for your understanding.

The PharmaLex Team