Readability Testing

Ensuring your patient information leaflet (PIL) is compliant and comprehensive

PLG’s experience shines in readability testing

We provide readability tests, focus tests, and bridging reports. Our experienced team follows the procedure set by the European Medicines Agency (EMA) and can cover all types of submission procedures (centralized, mutual recognition, decentralized, and national). We test leaflets for the medicines of all therapeutic groups — from simple generic products to more complex biotechnology products. We aim to minimize the number of tests performed to expedite your approval process.

While our primary focus is readability testing in the EU and UK, regulations apply to Eurasian Economic Union (EAEU) procedures. We support clients with testing to be conducted locally with native speakers in English, French, Russian, Romanian, Italian, Spanish, and many more.

Mature students and their teacher in a classroom

PLG’s team is prepared to address the various challenges a company can face during the testing stages. Our expertise lies in:

Readability tests for medicinal products
Bridging study (double bridging, format bridging) and bridging statement
Focus tests
Testing alternatives: we have had a high success rate with delivering clients a cost-saving method, which involves conducting focus testing and preparing a bridging report in various formats and bridging statements.

This looks like itll work. Cropped shot of a handsome senior man reading a bottle of prescription medication.

PLG’s team can also support non-standard readability testing services:

PLG can perform not only standard readability testing on the leaflets alone but can also adapt or combine them with usability tests of different types of packaging/relevant documents or accompanying a medical device, such as:

– Documents relevant to patients accompanying medical devices (example: implant card, SSCP)

– Usability test of a medicine bottle based on the instructions listed on the label only (immediate packaging)

– Combination of package leaflet testing with usability of the medicine bottle

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PLG offers experience and accuracy as advantages to our clients

We have provided readability testing for 18 years and have 100% accuracy with no deficiencies received from health authorities.

We have many resources and can carry out multiple tests simultaneously. Our solution provides a cost-effective approach for our clients.

We have tested more than 4,000 leaflets; all European medical agencies, EMA, MHRA, and agencies of EAEU accept our user test outcome reports. Our teams collaborate to provide complex services (medical writing, PIL mock-up creation, translation, and user testing).

KEY FIGURES :

4,000+

Readability tests conducted by PLG

1,000+

Additional testing services conducted (double bridging, bridging statements, focus tests)

Global clients.

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Test of the medicine bottle and label together

Challenge: Accessibility and correct use of medicine to be taken in an emergency, in case of a heart attack, as a first measure until an ambulance arrives.

Approach:

– Testing: 2 rounds, 6 participants each

– Demographics (people over 40 years old, 50% male and 50% female)

– Each participant is literate in English

– Questionnaire with 9 questions in total: 4 to the information on the label and 5 to the format of the label and user-friendliness of the bottle.

Results: The interviewer recorded how long it took each participant to open the bottle following the instructions on the label. The PIL was 100% successfully accepted by the health authorities.

Expectant woman read leaflet take tablets medication or suppleme

Usability test of non-standard primary package

Challenge: PIL user test + usability test of the bottle in the same interview

Approach:

– Testing: 2 rounds, 10 participants each

– General demographic (age: over 18 years old, 50% male and 50% female)

– Each participant is literate in English. The questionnaire had 17 questions to cover key safety information in the PIL, 3 questions about the format of the PIL, and 4 additional questions to evaluate the user-friendliness of the medicine bottle.

Results: Based on the test results, the user instructions were improved and entirely accepted by the health authorities.

To test or not to test?

We aim to minimize the number of tests you must perform and to expedite your approval process. We will review your portfolio, assess the leaflets, and advise on the best approach.

Yulia Alshibaya

Readability Testing Team Lead