Readability testing Services
Readability testings of patient information leaflets (PIL) are also referred to as Readability User Testing (RUT). Basically this is your Module 1.3.4. Knowhownow has been involved, as contractor and subcontractor, with readability testing since the beginning of the requirement in November 2005.
Readability testing services we offer MAH’s:
– Draw bridging reports
– PIL reformatting to current QRD
– Review of the Word text. Amendments are based on technical readalitity, use of laymen terms, thousands of interviews etc. All in order to optimize readability (i.e. legible, clear and easy to use). Sometimes even prioir to testing.
– Mock up design: we comply with all National Agency Specifications as well as your company’s design specifications
– Printing mock-ups in small batches
– 3D mock-up preparations
– Quick turnaround in as little as 3 weeks.
– Reports in compliance with guidelines, ready for submission to these authorities (eCTD compatible). In English or National language.
– Cost effective solution (very competitive costs).
– 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 native interviewers in the following countries: Netherlands, Belgium, UK, Italy, Germany, France, and Sweden.
– A readability test can be conducted during your clock-stop, or even before Day 0.
For more information about our readabilitytesting servicess or a quotation, please send us an email to email@example.com or give us a call at 003143982065.
All readaility testings are conducted in accordance with EU code of conduct.