Patient Information Leaflets (PILs) are required for all medicinal products in Europe and must be tested to establish readability. RApport has run user tests since they became mandatory in 2005.
We operate a standard process for user testing which involves a small pilot test followed by two Rounds of testing, with 10 subjects in each Round.
With our experience we are able to advise you on the layout and wording of your PIL from the start and are happy to draft your PIL from the SmPC. All you need to do is help us decide the most important key safety messages for the patient so that we can adapt the test to the product. We can also arrange the artwork and design of the PIL if required.
We will deliver a submission ready report including the information required by the European Regulatory Agencies. We are also able to provide bridging reports if you have user testing reports for other products with similar text and layout. These can sometimes be used instead of a full Test.