The ability of patients to take their medicines correctly is crucial to minimise adverse events, to maximise compliance and to promote the optimal efficacy of the treatment. Understanding the information provided in the Patient Information Leaflet (PIL) is critical in ensuring medicines are taken appropriately.
PILs always involve medical terminology difficult to understand by the average patient and their readability is often neglected.
Health professionals (nurses and doctors), themselves, have sometimes difficulties to access important information.
Since 2005, European legislation requires that PILs must undergo testing to demonstrate that they are written in clear and understandable language and to ensure that patients are able to find relevant information and to act upon it appropriately. This is referred to as “readability testing” or “user testing”(see reference documents).
We provide PIL Readability services in French, Duch and English
Squarepoint-Pointcarré, a CRO dedicated to medical writing and regulatory affairs, and ResearchLink, a Clinical Trial Network with a large network of investigators, have joined their skills and competencies (see our experienced team) to help regulatory departments of pharmaceutical and bio-pharmaceutical companies to fulfil these new European guidelines for ethical, generic and OTC products (see our services).
