Patient Information Leaflet

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Patient Information Leaflet

Are Your Patient Information Leaflet Truly Understandable to Patients?

Clear and understandable Patient Information Leaflet (PIL) are not only a quality element but also a crucial requirement for licensing processes. PIL Readability Testing reveals whether the information provided is truly understood by target users, enabling them to use the medication safely and correctly.

We Manage the Readability Testing Process from Start to Finish

From test planning and participant organization to the results evaluation report and final documentation to be submitted to the authority, our expert team manages the entire process end-to-end. By preparing a compliant, complete, and audit-ready file, we ensure the secure progress of your licensing processes.

Our Service Advantages

Testing Process in Compliance with Regulations

We plan and conduct instruction manual readability tests in accordance with relevant requirements.

Licensing Process Ready Reporting

We report test results in a format that can be used in licensing application and evaluation processes.

Patient-Friendly Content

We evaluate whether the patient understands the information in the instructions for use correctly and easily.

End-to-End Consulting Support

We provide support at every step, from test planning and participant selection to the results report.

Patient Information Leaflet Readability Test Services
PIL Readability Test Quality Steps

Why is a Readability Test of Patient Information Leaflet Necessary?

The Patient Information Leaflet (PIL) are a critical document for the patient to use the medication correctly and safely. Insufficient clarity of the instructions can lead to incorrect dosage, non-compliance with treatment, and risks to patient safety. PharmaSoft plans and executes the PIL readability test process in accordance with regulatory expectations. We provide expert consulting support in the preparation of the test protocol, conducting interviews with target users, analyzing the data, and preparing the results report ready for submission to the authority.
  • Preparation of the test protocol
  • Conducting interviews with target users
  • Data analysis
  • Reporting of findings
  • Results report ready for submission to the authority
  • Data management in accordance with the GDPR
Our goal is to evaluate the patient comprehensibility of your patient information leaflet and to provide reliable documentation support for your licensing process.