Demonstrating that patients can easily find and correctly understand the information in the patient information leaflet (PIL) is a mandatory part of marketing authorisation applications. We design, conduct and report readability tests and bridging reports in line with TİTCK guidelines, the European Commission readability guideline and CMDh documents.
Readability (User) Testing
- Pre-test readability assessment of the PIL and recommendations for improvement
- Preparation of a product-specific question set and test protocol
- Recruitment of participants matching the target user profile
- Pilot test followed by test rounds
- Assessment of the acceptance criterion for each question: at least 16 of 20 participants must find and correctly understand the information
- PIL revisions between test rounds where needed
- Management of participant data in line with the Turkish Personal Data Protection Law (KVKK)
- Preparation of the readability test report in a format suitable for the marketing authorisation dossier
Bridging
- Demonstrating compliance on the basis of a previously tested PIL, without a new test
- Comparative analysis of content and layout similarity between the parent PIL and the daughter PIL
- Assessment of bridging suitability for new strengths, pharmaceutical forms, line extensions and similar cases
- Preparation of the bridging report in line with CMDh recommendations
- Identification of cases where bridging is not sufficient and recommendation of focused testing
Our process: Preliminary assessment → Protocol and question set → Testing → Reporting → Support in responding to authority questions
