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Readability / User Testing.

If patients can’t read it, it isn’t safe.

Arriello has offered a full RUT and labelling service including mock-up creation since its conception, and we are considered global industry experts.

Readability User Testing is an integral part of product compliance and is designed to ensure that product leaflets are “legible, clear and easy to use” for patients, in accordance with Directive (2004/27/EC).

Our readability test services include:

  • Review of the text and layout of the proposed PIL (Product Information Leaflet), and suggestions for improvement.
  • Questionnaire preparation.
  • Recruitment of participants.
  • Pilot test + Full readability test performed by an experienced interviewer.
  • Project management/administration.
  • Test protocol development and writing of the final report, including all results.
  • Support in addressing readability testing related deficiency letters.

Our test reports are prepared in English, but we can also conduct user testing in local languages, such as French, Spanish, German, or Dutch. Contact us for more information.

Mihaela Trandafir talks about readability and user testing…

Video: Regulatory Affairs Services – Readability User Testing (RUT).
Mihaela Trandafir
Senior Regulatory Affairs Specialist

Bridging studies.

We also offer Bridging studies, with or without focus testing, for any European country, and can help you by assessing if Bridging is appropriate for your submission.

In bridging, a successful user test on one PIL (the “Parent” PIL) can be used to support a justification for not performing a full test of a similar leaflet (a “Daughter” PIL).

When a Bridging report is not enough to support your project needs, we will help you outline a ‘’Focus test’’ concentrating on the significant changes, in compliance with a QRD template as well as relevant guidelines.

Bridging includes:

  • Review of the text and layout of the proposed PIL and suggestions for improvement, in compliance with a QRD template as well as relevant guidelines.
  • Review of previous consultations/readability tests.
  • Comparison of the ‘’Daughter’’ and ‘’Parent’’ leaflets in content, structure, and design.
  • Writing of a bridging report containing the rationale for bridging for submission to regulatory authorities.
  • Support in addressing readability testing related deficiency letters.