User Testing and Self-Selection Studies

PIL User Testing and Readability Studies

Patient Information Leaflets (PILs) are a vital part of pharmaceutical packaging, providing patients with essential information about their medications. Ensuring that PILs are clear, understandable, and user-friendly is crucial for patient safety and adherence. At ERA, we assist you in conducting PIL User Testing and Readability Studies to assess the comprehensibility and effectiveness of patient-facing materials. Here’s how our services in this area can benefit your organization:

PIL User Testing:

Study Design:

Our experts collaborate with you to design PIL user testing studies that reflect the diverse patient populations using your medications.

ERA ensures that the study objectives align with regulatory requirements and focus on user comprehension.

Participant Recruitment:

We can manage recruiting of participants from target patient groups, ensuring that the study represents the intended user population.

Usability Assessment:

ERA can organise user testing sessions, athering quantitative and qualitative data on user comprehension, satisfaction, and any difficulties encountered.

Recommendations for Improvement:

Based on study findings, ERA provides actionable recommendations for enhancing PIL content, structure, and presentation.

We help you prioritize revisions to improve patient understanding.

Readability Studies:

Content Evaluation:

Our experts conduct in-depth readability studies in compliance with latest legislation and guidance to assess the clarity and readability of PIL content, including language, layout, and typography.

Plain Language Recommendations:

Our experts can provide plain language recommendations for simplifying PIL content while maintaining accuracy and completeness.

They offer guidance on using plain language principles for improved patient comprehension.

Regulatory Compliance:

Documentation and Reporting:

ERA assists in documenting and reporting the results of PIL user testing and readability studies for regulatory submissions.

We ensure that your submissions meet regulatory requirements.

Self-Selection Studies:

Design and Execution:

Our experts can design and execute self-selection studies to evaluate how patients or healthcare professionals select and use pharmaceutical products.

These studies can assess factors such as labelling clarity, instructions, and ease of use.

Compliance and Adherence:

We can evaluate patient or healthcare professional compliance with self-selection instructions and assess any deviations.

Our experts identify potential barriers to proper product selection and use.

Recommendations for Improvement:

ERA provides recommendations for optimizing self-selection processes, including labelling revisions and user support tools.

We help you enhance product accessibility and safety.

By partnering with ERA for PIL User Testing, Readability Studies and self selection studies, you enhance the comprehensibility of patient information, contributing to better patient outcomes and medication adherence. Our commitment to rigorous study design, participant recruitment, usability assessment, readability evaluation, and regulatory compliance ensures that your PILs are user-friendly and meet the highest standards of patient communication.