User Tests for Clinical Documents

From clinical trial documents to lay summaries, educational materials, patient information, diaries, and questionnaires.

High comprehensibility and clear statements are essential for medical and pharmaceutical documents. They form a critical foundation for the safe and effective ingestion or administration of your product, build trust in your brand, and minimize the risks of medication errors and other hazards during use.

Lay summaries of clinical trial results are easily understandable descriptions of the design and overall results of clinical trials. The EMA mandated the submission of lay summaries through the EU Clinical Trials Regulation (EU CTR) 536/2014. Among other requirements outlined in the regulation, sponsors must submit a summary of clinical trial results regardless of the trial outcome. The summary must be provided in a "layperson-friendly format" and uploaded to the portal in all EU languages in which the study was conducted—one year after the end of trial (EoT) for adult studies and six months after the EoT for pediatric studies.

Information for physicians or patients must frequently be produced as educational materials as a regulatory condition for marketing authorization. The challenge here is to present important information—such as handling instructions—clearly and concisely. Ultimately, a user test demonstrates whether these complex materials genuinely ease the workload for physicians or serve as a practical aid for patients.

This applies equally to patient documents in clinical trials. Comprehensible documents ensure that study participants feel well-informed. This makes it easier for participants to understand the study procedures, motivating them to participate and contribute actively. As a result, optimal data collection and the highest possible data evaluability are achieved.

Using user testing based on the validated readability test for package leaflets, we assess whether your medical documents and data are clear and comprehensible for the target audience. Naturally, our many years of experience with clinical trials and our expertise in handling medical and pharmaceutical texts and design are incorporated into the development and optimization of your documents, helping to meet your required standards.

Thanks to our extensive pool of participants and our cooperation with various patient self-help groups, testing is also possible with specific target groups.

Timing, always possible: from product/study development to post-marketing

We are happy to test the following for you:

• Patient support and compliance programs (PSPs), including apps, software, and websites

DOCUMENTS FOR CLINICAL TRIALS:

• Lay summaries of clinical trial results (Lay Summary)

• Study descriptions, patient information sheets (PIS) for clinical trials

• Informed consent forms (ICF) for clinical trials

• Patient diaries

• Questionnaires to capture patient assessments, such as quality of life, perceived disease symptoms, and patient satisfaction (Patient-Reported Outcome [PRO])

MEDICAL DOCUMENTS:

• Educational materials for healthcare professionals (consultation guides, therapy guides, product preparation instructions)

• Educational materials for patients (materials for training programs, e.g., hypertension training)

• Patient Information Materials (information brochures, guides, checklists)