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Regulatory Affairs, Pharmacovigilance and Quality Assurance

More info about

Sofus Readability Tests

Our tests are performed in accordance with all applicable guidelines, and together with our experience from regulatory affairs – and authority evaluation of readability tests in particular – we can ensure a successful outcome.

Target patient groups – representative samples

As in any scientific trial on patients, the selection of the target group is very important for a true and reliable result. We always recruit the target patient group randomly based on the Central Registry of the Swedish Population. We take care to ensure that the target group is representative with respect to age and gender for the concerned product, with specific focus on the education level that should be in line with the education levels of the Swedish population in general.

The package leaflet

We use printed leaflets or pdf-mock ups in the tests. If required, we can assist the client with the design of the mock-ups in eps-format, as well as implement the text and/or design changes based on the results of the tests.

Reporting

The client receives the results of the readability test summarised as a written report that is ready for submission to the competent authority.

Timelines

After receipt of the printed leaflets or mock-ups for the product, we can normally supply a full test report within four-five weeks.