Proper written information on the medicinal product’s package leaflet is highly important for the safe, correct, and effective usage of the medicine. Thus, to ensure that the presented information is clear and comprehensible, Readability User Testing (RUT) must be performed with the patients to receive their feedback.
We offer the following services for successful Patient Package Leaflet Testing within the EAEU region:
- Development of the Testing Protocol
- Preparation of the Summary of Product Characteristics (SmPC) according to the local requirements
- Preparation of the Patient Information Leaflet (PIL) according to the local requirements
- Conduction of the Patient Information Leaflet testing with patient groups and implementation of the necessary corrections
- Provision of the final report on Patient Information Leaflet testing.
The findings from the testing are submitted to regulatory authorities as Readability User Testing Reports.
Biomapas has extensive experience with Readability User Testing, therefore our medical writers can effectively help you with this procedure by reviewing the package leaflet of your product and making sure that it is well-suited and understandable to the patients; by conducting a Readability User Testing study, summarizing its results and preparing Readability User Testing Report.
For any inquiry regarding our services, please contact Biomapas Business Development team.