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Our team performs all the necessary services within the framework of organizing and conducting the User / binding testing of the instructions for medical use (leaflet). User testing is a test of the package leaflet, aimed at studying the readability, clarity and accessibility of the package leaflet by target groups of patients. The goal of user testing is to provide a legible and easy-to-use package leaflet that will enable the majority of drug users to make safe and correct decisions about its use.
When is user testing required?
medicines contain new chemical compounds or are produced in fundamentally new dosage forms (new for the EAEU market)
change in dispensing conditions (prescription to non-prescription)
significant change in security information
adding new guidelines and associated new patient populations
Why us?
We work in full compliance with the requirements of Decision of the EEC Council No. 88, Decision of the EEC Council No. 78
Flexible pricing
Short terms, depending on the needs of the client
Representative Sample
Our team has completed more than 100+ successful projects
The leaflet user testing service includes the following steps:
Project start
Preparation of Protocol PT LV
Preparation of the PL User Test Protocol, including the Questionnaire
Coordination of the LP User Testing Protocol with the Customer
Pilot stage
Recruitment of the target group of respondents
Interviewing a limited number of respondents (according to the Protocol)
Overview of the results of pilot testing of drugs, recommendations
Making changes to the layout of the LP and the Questionnaire (if necessary) and agreeing with the Customer
Stage 1 and Stage 2
Conducting interviews of respondents
Overview of the results of the first and second stages of drug testing, recommendations
Making changes to the layout of the LP (if necessary) and agreeing with the Customer
Preparation of the Report and Summary of PT LV
Final statistical processing of collected data
Preparation of the Report and Summary
Coordination of the Report and Summary with the Customer
Completion
You can provide only the molecule name, and we will develop the entire strategy for bringing the drug to market: from designing, calculating the sample size, selecting a reference drug, its procurement (in the Russian Federation or import), to writing the final report on the conducted research and submitting it to regulatory authorities.
Fill out the feedback form and we will provide you with a set of documents, which includes: