Package leaflet user testing
Package leaflet testing is a test of the package leaflet
(instructions for medical use) aimed at studying the readability,
clarity and accessibility of the information to the target groups of patients.
We provide a service for user testing of the package leaflet in accordance with the requirements of Decision No. 88 of the EEC Council of 03.11.2016
Package leaflet user testing is required for almost all medicinal products in order to prove the readability and understanding by patients of the intended information.The result of user testing is a user test report proving that the information in the package leaflet is presented in a convenient and understandable form for potential users.User testing allows you to test the design of the PL and improve it. As a result of user testing, we will give recommendations on the advantages and disadvantages of the package leaflet which will help minimize the possibility of additional requests from the regulatory authority.If your medicinal product meets the binding criteria described in Council Decision 88, we will prepare binding user testing for you, which will significantly help optimize your budget.What does user testing include?
01
Pre-assessment of the package leaflet
02
Test protocol development
03
Printing user testing documents
04
Conducting a survey of 20 respondents (meeting the inclusion criteria)
05
Analysis of results, statistical processing of data
06
Preparing a user testing report
