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READABILITY TESTING OF PILs
THE METHODOLOGY OF THE USER TESTING IS BASED ON THE MHRA GUIDELINE
(according to the requirements of the Directive 2001/83/EC as amended)


The USER TESTING comprises:

  • Review of your existing PIL and suggested revision. The PIL is reviewed by our  experienced PIL writer. This is to ensure the PIL will pass a user test and complies with current guidelines.
  • Creation of Questionnaire (approximately 12 -15 questions which are designed to prompt the participant to find in the PIL certain items of information which reflect specific safety issues related to the medicine being tested. They are then asked to explain this information in their own words. The questionnaire should have a balance of specific and general questions. These questions should be randomized and not appear in the same order as they appear in the PIL. This is sufficient to identify potential problems and implement changes.
  • Recruitment of target-group of 23 - 25 participants are recruited to suit the widest range of demographics available and who are considered to be within the target group. Participant selection is based upon criteria complying with the guidance of the MHRA, to ensure valid test results. Participants selected are, wherever possible, people who do not use written documentation at work, are not over-educated (the maximum education of a participant is 4 years of University) and who admit to having had difficulty with PILs in the past. Participants are excluded from the test if they work in medical, pharmaceutical or media industries. 

  • A pilot testing is performed to identify any problems prior  to full user testing (on a group of 3 volunteers).

  • 1st round testing is performed with 10 participants.
1st round results are analyzed and reviewed for quality.
Any revisions to the PIL are suggested to the MAH

  • 2nd round testing is performed with 10 participants to re-test implemented changes.
If the PIL achieves a satisfactory test result based on the 2nd round testing, the final report is created in English (or other language), ready for submission to the Authorities. If the PIL does not achieve a satisfactory result, 3rd round testing may be necessary. (A satisfactory test outcome is when 90% of literate participants are able to find the information displayed in the PIL and 90% of those are able to explain the information in their own words).
The single user test takes no longer than 45 minutes.

  • Complete report production, ready for submission. This report details the entire process of the user testing of your PIL and provides information about the outcome of the user test which can be submitted to an Authority.

OTHER SERVICES:

Faithful translation – Pharmbicon offers Clients a service to translate faithfully medical documents into English, German, Polish.

  • Bridging and portfolio assessment  –  it is not necessary to user testing every single PIL !! We can advice on the most effective strategy for testing a portfolio of products to bridge the results of user testing across different products.

TIMELINES

With standard user testing, the typical timeline from project inception to completion is 2 - 3 weeks. If an additional round of testing is required, the process normally takes an additional 1 - 2 weeks.

QUALITY CONTROL
  • interviews are performed by professional interviewers 
  • we respect the ESOMAR code
  • interviewers are trained before each testing by Pharmbicon’s professional
  • all reports are validated by our regulatory affairs professional to ensure acceptance by an authorities
  • all interviews are recorded and checked for accuracy.

WHY choose  pharmbicon ?

  • we have the expert ability to user test PIL's, packs and any other written material which may be intended for users of your product
  • we are an established consultancy company with the long experience in the pharmacy (5 years)
  • we offer a   f i x e d  p r i c e   user testing service, no hidden costs!
  • we make customer satisfaction as the absolute priority.