We perform full testing services for different medicinal products and formulations.
We offer our clients:
- wide database of PIL’s potential users recruited from varied sources, ensuring a broad selection of age, gender, education and socio-economic groups, our database is continuously extended,
- consultancy on the leaflet information and layout (comparison of the SmPC and PIL and adjustment to QRD template and other requirements), proposition of changes which improve the legibility of the leaflet and if necessary writing a new leaflet from existing SmPC or rewriting the leaflet for compliance with current regulatory requirements,
- recruitment of appropriate target population adjusted to the requirements and content of the PIL,
- performing the test according to the current guidelines (pilot testing, round I and II of testing, analysis of the results and introducing necessary changes, if needed),
- preparing all necessary components of the Module 1.3.4: protocols, questionnaires and final reports from the testing in required languages and submitting them to our client or agencies both in hard and electronic copies,
- audio recorded interviews,
- staff experienced in testing,
- the justification for the exemption of User testing.
