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User testing and patient consultation of package leaflets

 

Full service in user testing of package leaflets(PLs) according to EU and national guidelines.

 

Based on our know-how and experience Clinagil provides advice on package leaflet wording and content prior to any testing. This assures a smooth process to a successfully completed user test.

 

The user test is planned in agreement with own SOPs conform to the draft guidance from august 2005 concerning consultations with target patient groups” for the package leaflet and “A guideline on the readability of the label and package leaflet of medicinal products for human use” by the European Commission, 1998.

 

The user test is performed according to a standardised protocol. The questions are selected specifically for the product to be tested. This assures relevance to the product and coverage of the questions to the potential user problems of the tested product.

 

A written report with full documentation of the readability test procedures and outcome are delivered.

 

Clinagil can currently provide readability testing of PLs written in Danish. If your PL is not available in Danish it will be translated prior to testing. All test documentation is provided in English.