PIL Readability Testing

Making things clear for patients

Full PIL Readability Testing
Making things clear for patients

Pi² has over 30 years’ experience in involving patients in the development
of health information. Working with pharmaceutical companies in the UK
and Europe, we have conducted over 150 PIL Readability tests for Brands,
generics, Prescription Only and OTC products with a 100% success rate;
with no questions from regulators over the past 10 years.


Mock up & text review

Review of package information leaflet text and mock up to optimise readability and check compliance with current guidelines.

PIL User Testing Protocol

Analysis of key safety and compliance messages, question design, development of questionnaire, data sheets and printing of PIL mock ups. Pilot testing on 2-3 test subjects, two rounds of main testing on 10 test subjects per round.

Test Subjects

Selection and reimbursement of test subjects ensuring strong representation of elderly (if appropriate) and people with lower literacy levels.

Final Test Report

Summary findings reported to sponsor after each test phase with any recommendation(s). Production of final test report presented as one PDF ready for submission (within Module 1.3.4).

Bridging Studies


Bridging Strategies

Strategic advice on Bridging Strategies to maximise use of full tests.

Bridging Suitability

Assessment of PIL to determine suitability for Bridging and to identify suitable tested ‘parents’.

Focus Testing

Focus testing of areas of difference between parent and untested ‘daughter’ documents.

Results Studies

Full studies documenting synergies and differences and relevance of user test results.


Medicine Pack Design Testing

Bespoke test solutions? We’ve got some bright ideas.


Medical Device Testing

It’s never been more important to be in safe hands.


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