Medical Reading conduct readability user testing of patient information leaflets according to Directive 2001/83/EC as amended by Directive 2004/27/EC. Readability user testing is conducted on the basis of methods of linguistics, communication and social sciences.

Compliant User-Tests

Tests are accomplished according to current guidelines of the European Commission, the EMEA and the national authorities.

Scientific background

The evaluation of readability is based on scientific approaches like of our work are the studies of the Communication Research Institute, Sydney and social science research of Prof. Dr. Uwe Flick and Dr. Jan Kruse.

Quality assurance

Medical Reading applies quality assurance standards of the pharmaceutical industry. All steps of the procedure are defined by SOPs.

Design and typography

Medical Reading and their partners are experienced not only in linguistics, but also in design and typography of consumer friendly information.

Reporting

The final reports of the user-tests are generally written in English. They contain the quantitative and qualitative evaluation results, a test protocol, questionnaire, confidentiality and consent forms, a medium containing audio recordings of the interviews and further documents required by the authorities.

Member of DIA

Knowledge about actual European legislation and regulatory affairs is kept up to date amongst others by a membership of the Drug Information Association (DIA).

Medical Reading and Text-College

Medical Reading is a subdivision of Text-College OHG, since 2000 academy for the education of copywriters and authors of product information.

Medical Reading

Wolf Bruns

Adam-Berg-Str. 188

81735 München
Tel.: +49-89-68 09 95 93 
Fax: +49-89-68 09 95 92

E-Mail: info@medical-reading.de