Our PIL readability testing protocols and reports have been submitted to the European Authorities and have been accepted without comments or reserve.

Our timelines and prices are made very competitive due to the fact that resources are used optimally. Administrative matters and bureaucracy are reduced to the minimum to guarantee a total focus on the customer's needs.

Our tasks are undertaken under secrecy agreement.

We have access to the general population living in Belgium and more particularly in Brussels, which is largely multi-cultural. Depending on your requirements we can access specific target patient populations (such as children, elderly adults, the blind) and/or health professionals (such as nurses, pharmacists, GPs, specialists in all therapeutic fields).

Services we can provide to your company include:

  • Writing and designing PIL that meet legal obligations
  • PIL readability and usefulness testing and reporting that meet legal obligations (including subjects recruitment, independent interview, results analysis, advice on PIL improvement and final report)
  • PIL readability and usefulness testing by health professionals (nurses, pharmacists, GPs,
    specialists in all therapeutic fields)
  • We provide PIL Readability services in French, Duch and English
  • Testing the Braille language (collaboration with the Braille's League)
  • Expert advice on your PIL based on your SPC
  • Devise a plan for the testing of key leaflets that will permit bridging studies to be completed for all of your currently marketed products

Basically, a PIL readability and usefulness testing will consist of a 6-step package:

  1. Analysis of the current leaflet and preparation of evaluation questionnaires (standard to all leaflets and specific to the concerned drug)
  2. Planning of the testing methodology
    • Target populations
    • Number of patients
    • Availability of patients
  3. Instructions to general practitioners
  4. Collection of data
  5. Statistical analysis of collected data
  6. Report for the regulatory bodies (according to the recommendations of the Directive 2004/27/EC)
    • Product description
    • Test or consultation details
      • Method
      • Choice of population
      • Language tested
    • Questionnaire
    • Original and revised package leaflets
    • Summary and discussion of results
    • Conclusion