User Testing &

Readability Studies

User testing or other form of patient consultation ensures that patients’ views on the content, and design and layout are taken into account so that the final Patient Information Leaflet which is submitted as part of the Marketing Authorisation application enables medicine users to take safe and accurate decisions about their medicines.

We have well established networks available to conduct readability testing of labels and leaflets to comply with the UK and European requirements. We have experience in establishing the key messages for safe use and preparing suitable questionnaires. We can carry out pilot studies as required, and conduct the interviews of appropriate subjects as required. Once the data has been collected the following activities can be completed as required:

Validation of results and amendment of labelling as appropriate

Preparation of user test report

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Preparation of bridging reports

Submission of applications to regulatory bodies

Management of products through the assessment process

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