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Product Information User Testing

Regulation in most regions is increasingly focused on effective communication of medicine information to patients.  This is especially advanced in Europe where consultation with and user testing by target patient groups is required to demonstrate that patients can find and understand key messages for the safe use of the medicine.

Whether you require one test or the testing of your entire portfolio, Fulcrum Pharma provides comprehensive solutions to meet your needs.  If your portfolio contains several similar patient information leaflets (PILs), we can conduct a detailed assessment of these to create a strategy to ensure that user testing is carried out in the most cost effective way.

Fulcrum Pharma provides a highly experienced team of Regulatory Professionals, Interviewers and Data Analysts to support the testing and reporting of your PILs, we are focused on a quality service that is continuously reviewed to keep up to date with regulatory agency guidance and client needs.  Our clients range from large multinationals to small start-up companies.

All interviewers are fully trained in the specific field of user testing patient information.  As a member of the Market Research Society (MRS) Fulcrum Pharma ensure that all interviewers are accredited members of the society.

Our standard user testing service includes:

• Readability review of PIL text including guidance on design and layout
• Cross check of PIL text to SmPC and QRD
• Assist client to establish the key messages for safe use
• Questionnaire preparation and pilot as required
• Conduct 2 rounds of interviews using 10 subjects in each round
• Validate results and feedback to client at each stage
• Prepare user testing report to meet EU Directive

Other user testing related services we offer include:

• Bridging techniques including - statements, reports and studies
• Rewrite or align PIL to QRD format
• Conversion of SmPC to PIL
• Multi-lingual translation services
• Prompt responses to any questions from competent authorities

We also provide testing in other languages, if for example, you require your PIL to be tested in your local language.

We have practical experience of user testing in a wide range of products and procedures:

• POM, OTC and Generic PILs, Devices and Packaging
• Centralised, Decentralised, Mutual Recognition, and National Submission Procedures

Whatever your requirements Fulcrum Pharma can provide a bespoke service to suit your needs.

For more information, please send us an email.

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