Written information accompanying medicinal product is very important for the patient safety and effective use of the medicine. Therefore, to ensure that this information is clear and easy to use, Readability User Testing of the package leaflet needs to be performed as a consultation with the patients. The results of these studies are then described in Readability User Testing Reports which are submitted to regulatory authorities as part of the dossier.
Biomapas has an extensive experience with Readability User Testing, therefore our medical writers can effectively help you with this procedure by reviewing the package leaflet of your product and making sure that it is well-suited and understandable to the patients; by conducting Readability User Testing study, summarizing its results and preparing Readability User Testing Report. Alternatively, our medical writers can assess if your medicinal product is a good candidate for an abridged version of this procedure and prepare a so-called Bridging Report.