Readability Testing of PILs and Bridging
Readability testing of patient information leaflets (PIL) is a process designed to test medical product leaflets to ensure the text displayed is “legible, clear and easy to use” for medicine users, as defined by the European Directive 2001/83/EC, and amended by Directive 2004/27/EC.
Since 2005, all manufacturers of medicinal products must pay special attention to the readability test process as it has been a legal requirement in European countries in order to obtain the approval for their product.
At Novalins, our Life Sciences Division has specific involvement in readability user testing and our experts are backed up by the experience of successfully completing hundreds of readability tests in the frame of CP, MRP, DCP and national submissions. We work in close collaboration with Regulatory Affairs specialists to ensure that the patient information leaflet of their drugs and medicinal products are correctly readability-tested.
Our readability test services include:
- A thorough review of the text and layout of the product information leaflet (compliance with QRD template according to the procedure – CP, DCP, MRP or national submission – checking of grammar, spelling, clarity)
- Questionnaire and protocol development
- Screening and recruitment of suitable participants
- Pilot test performed by an experienced interviewer
- Further development of the PIL based on the pilot test results
- Full readability test on 20 participants native in the language
- Submission of a complete report including all test results
Novalins offers full readability tests mainly in English but also in other languages, such as Dutch, French, German or Spanish.
In addition to readability testing and bridging strategies, we also assist regulatory affairs specialists with the following main solutions:
- Medical writing (PIL writing / review)
- Medical translation of the SmPC, PIL and labelling in all European languages for marketing authorisation
- Medical transcription
- Mock-up creation
- Clinical translation
- Medical language translation of the Common Technical Document (CTD module 1, CTD module 2, CTD module 3, CTD module 4 and CTD module 5)
- Linguistic validation of Patient Reported Outcome (PRO) measures