Global Regulatory Affairs

Readability User Testing is used to ensure that a set group of people are able to understand and act upon the information given in a Patient Information Leaflet (PIL). This test is conducted as a regulatory requirement within the pharmaceutical sector to improve the readability of PILs.

We offer our clients a free assessment of their portfolio of products and then advise them accordingly to ensure full compliance with Readability User Testing (RUT) requirements.

Method used during RUT

We aim to ensure that the demographic characteristics of the group tested correspond to those of the territory where the product is to be marketed, while taking into account all national as well as European Medicines Agency (EMA) requirements.

  • Revision of PIL. The leaflet is revised by an experienced PIL writer and the Test Supervisor. The goal is to ensure that the PIL has a very high probability of passing the user readability test and that it complies with the latest requirements.
  • Creation of the test questionnaire.
  • We then liaise with the client to ensure that he/she is fully satisfied with the questionnaire prior to starting the test.
  • The target group of participants is recruited. It consists of potential users of the medicine in question of similar demographic characteristics as potential patients. Participants are selected based on guidelines set by the Competent Authority and Concerned Member States (CMSs).
  • A pilot round is conducted initially to identify any major issues with the PIL. These would have to be resolved prior to starting the test.
  • The test results are discussed with the Marketing Authorisation Holder (MAH) and revisions are considered and discussed, as necessary.
  • The first round of tests is conducted.
  • The results are analysed and reviewed and the provisional quality report drafted. The client shall be sent a copy, if requested.
  • Any revision to the PIL as suggested by the MAH.
  • The second round of tests is then conducted.
  • If a satisfactory result is attained after the second round, the final report is drawn up in the required language ready for submission. If a satisfactory result is not achieved, a third round of tests may be necessary.
  • Preparation of the final report.

Bridging Studies

Bridging studies can minimise the number of RUT to be conducted if a new “daughter” PIL is similar to the original “parent” PIL.

 

We have vast experience in this field and here again we can help you save time and money by using this system and in some cases across different languages.

Focus-testing can be implemented in the case of a small number of significant differences in the contents of the PIL.

Our Experience

We have participated in over 1,500 RT and Bridging Studies, meeting our clients’ needs in any country where it was required. We conduct the tests in the local/national language as required. We started our commercial activity by offering our customers RT, so our experience, references and the number of successfully delivered projects endorse our services.

Benefits for end-user

  • Improved comprehension of information provided
  • Better decision-making resulting from being better informed.

Benefits for companies

  • maximise product sales by delivering effective messages to the end-user
  • cost reductions: administration, printing and packaging and consumer support.

Project Management

We have an experienced multilingual team of professionals who always adopt a project-oriented approach. Thanks to this multi-language management, we ensure that the results are understandable to everyone in any language.

Business Cases

Contact Us

If you are interested in our service please contact us for more information.

Telephone+353 125 44033
Email: marketing@arriello.com

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