Readability testing

Knowhownow has been involved with readability testing since the beginning of the requirement by EMA in November 2005.

 We offer our clients:

• Submission-ready 1.3.4 documents (eCTD)
• Timelines possible between 2 and 10 weeks (respecting your clock-stop slots)
• Design and printing of mock-up for testing purposes
• Testing possible for all European authorities
• All PL´s, Rx, OTC and hospital products
• CP and MRP
• Testing for Patient Instructions, Instructions for Use
• Experience with decades of interviewing respondents which results in a pre/test assessment of the readability of the PIL

Pre-test assessment, a pre-test assessment of the User information. Potential problematic areas of the leaflet will be identified and communicated to the client, if possible/ applicable with suggestions for amendments 

Review of the Word text (based on thousands of interviews) for optimal readability. An extensive review of the text and layout (additional costs), potentially followed by a pilot test 

– Mock up handling

• Design we comply with all National Agency specifications as well as your company’s design specifications
• Printing in small batches
• 3d mock-up preparations

– Quick turnaround in as little as 4 weeks possible.

– Reports according to the guidelines, ready for submission to these authorities.

– Bridging solutions.

– 100% approvals to date.

– Proven effective test methods according to various guidelines, including the EMA (EU), MHRA (UK), CBG-MEB (NL), FAGG (Belgium),  ANSM (France), BfArM and PEI (Germany), AIFA (Italy).

– Our own experienced interviewers in the following countries: Netherlands, Belgium, UK, Italy, Germany, France, and Sweden.

Readability testings of patient information leaflets (PIL) are also referred to as Readability User Testing (RUT).

For more information or a quotation, please click the link below, send us an email to info@knowhownow.nl , give us a call on 0031643982065.