Readability User Testing for Patient Information Leaflets
M.P.C.A. International BV has been involved with readability testing since the beginning of the requirement in November 2005 and has developed a validated webtool to facilitate the work and handle a databank of readers.
Readability testing — why it matters
"Reading the information on a leaflet is not the same as understanding it."
The most important part of our work is to ensure that people understand how to use a medicinal drug safely and correctly. Readability testing of Patient Information Leaflets (PIL) generates a validated Module 1.3.4 in the eCTD.
The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use. M.P.C.A. has developed a validated webtool — visit www.MPCA-leesbaarheid.be
Request a quotationValidated by these authorities
🇪🇺 EMA (EU)
🇬🇧 MHRA (UK)
🇳🇱 CBG-MEB
🇧🇪 FAGG/FAMHP
🇫🇷 ANSM
🇩🇪 BfArM/PEI
🇮🇹 AIFA
What we offer for readability testing
PIL reformatting to current QRD template
Review of Word text (20 or twice 10 interviews) for optimal readability
Mockup handling
Quick turnaround — as little as 48 hours within 4 weeks
Reports according to guidelines, ready for submission
Cost-effective solution — very competitive pricing
100% approval rate to date
Proven effective test methods — online available during special circumstances
Need a readability test for your PIL?
Contact us for a quotation or more information. Call us on +32 476 66 47 05 or send an email to info@mpca.be.