Archemin

Advice & reporting for the chemical and pharmaceutical industries

Pack Insert Readability testing according to EU guidelines

All Patient Information Leaflets (PILs) for new products have to undergo readability user testing

Archemin’s multilingual team – Dutch, French and English – offers full PIL user testing services in compliance with both EU and national guidelines!

A full report, including description of the test procedures and documentation of the outcome, is provided. This com­prehensive document in support of the proposed Patient Information Leaflet is provided, ready for inclusion in the CTD, without additional work.

Preliminary advice

  • Patient-friendly wording
  • Layout / development of a "house style"

Developement of a standardised protocol and questionnaire

  • Specifically designed for the product to be tested
  • Ensures adequate coverage of all relevant issues

Volunteer test panel

  • Experienced interviewers
  • Testing in French, Dutch or English

Analysis

  • Clear proposals for readability improvement

Final report

  • Comprehensive documentation
  • Ready for inclusion in the e-CTD
  • Proven quality

Want to know more / require a quote?

Send your request to mi [at] archemin [dot] eu