User tests for clinical documents

Documents for clinical trials including lay summaries, educational material, patient information, diaries, questionnaires

Clear writing is very important in medical and pharmaceutical documents. It supports the safe and effective use of your product, it enhances consumer confidence and it minimizes risk.

Lay Summaries are plain language descriptions of the design and aggregate results of clinical studies. The EMA initiated the call for the submission of lay summaries through the European Union Clinical Trials Regulation (EU CTR) 536/2014. Among others elements described in the regulation, sponsors must submit a summary of the results of the clinical study, together with a summary and the Clinical Study Report (CSRI, irrespective of the outcome of the study. The summary must be provided in a “format understandable to laypersons”, with posting to the portal 1 year after the end of the trial (EoT) for studies in adults, and 6 months after the EoT for studies in the pediatric population, in all the EU languages in which the study was conducted.

Educational material for physicans or patients are often additional requirement for your registration. The challenge is to give the most important information clearly any easily written in the short. Finally an user test indicates whether the complex material is supportive for physicans or patients. 

This likewise applies to patient Information documents in clinical trials. Clear writing ensures that study participants are well informed. It also encourages their active participation and adherence to the study schedule, which as a result optimizes data collection.

Using validated methods, our readability user tests check whether your medical and pharmaceutical documents are clear and understandable to the target group. Our analysis incorporates our extensive experience with clinical trials and know-how regardingmedical/medicinal and pharmaceutical texts.

We maintain an extensive test person panel in both Germany and the UK and have the cooperation of several patient self-help groups.  Therefore we can target, as much as possible, a test to its intended readership.

We are looking forward to test for you:

  • patient support / compliance programs (PSP), also providing apps, software, and/or websites in combination with a user test

DOCUMENTS FOR CLINICAL TRIALS:

  • summary of the results of the clinical trial for laypersons (lay summary)

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

  • informed consent forms for clinical trials (ICF)

  • patient diaries

  • questionnaires to record patient assessments (patient-reported outcome (PRO)), such requests about the quality of life, experienced symptoms, and satisfaction of patient

MEDICAL DOCUMENTS:

  • educational materials for medical professionals e.g. consulting documents, therapy guidebooks, and product preparations

  • patient training materials e.g. hypertension-training

  • patient brochures, guides, and checklists