Readability User Testing

• readability tests of medical information in all EU official languages 
• medical writing: creating and optimisation each type of medical information
• typesetting: layout and design development for any kind of medical information
• usability tests of application devices
• bridging studies
• studies of various medicinal and healthcare issues

• Patient information leaflet and SmPC preparation 
• One-on-one interviews with 20 volunteers from the medicinal product’s target group
• Readability user test with native speakers in either the United Kingdom or Germany
• Evaluations performed immediately after each interview, allowing for confusing passages to be corrected quickly and reducing costs for the test
• Analysis of the data based on the evaluation criteria of the European authorities
• Alternatively: bridging study, focus test
• We prepare all documentation for the CTD module 1.3.4 ready for submission

• Readability testing and PIL writing experience since early 2007
• The need for user test is checked first
• PIL reformatting to comply with QRD (Quality Review Document) and Readability Guidelines for optimal readability
• Validated quality procedures
• Very competitive costs with fixed price policies (no hidden costs)
• Reports ready for Submission (namely eCTD ready reports in PDF 1.4, with applicable bookmarks)
• Included reply to possible inquiries from the authorities following submission
• Mock-up development according to readability guidelines

KHN’s core competence is the conduction of full service readability tests. This comprises the following:

• Conduction of readability tests in Germany, BeNeLux, France, England, Sweden, USA
• Project time: 4 weeks
• Optimization of the Word text
• Adaptation of existing text to the current QRD template, taking into account other applicable guidelines
• Layout and design of the leaflet artwork and mock-ups conform the house-style of the client
• Advice on the optimal compilation of readability tests on several PiL's
• Bridging reports and Focus reports in English (ready for submission)
• User test of application aids and IfU’s (Instructions for Use)
• We provide all documentation for the eCTD module 1.3.4, complete for submission (in PDF)
• Possibility for our customers to be present during the interviews (live or live stream - limited to GDPR)
• 13 years of experience in readability testing (references on homepage)
• Interviewers and subjects are all native speakers
• Interview data are recorded word by word per subject and question (100% transparency)
• Unique internal quality control system
• Fast and easy-to-use RfQ (hyperlink: https://www.knowhownow.nl/contact-rfq/)

PHARMEXON’s lead interviewer has been involved with Readability User Testing of Patient Information Leaflets (PILs) since the beginning of the requirement in EU.

PHARMEXON provides:

• Readability testing and PIL / SmPC writing
• PIL reformatting to QRD and for optimal readability
• Guaranteed Acceptance Across the EU for National, MRP, DCP and CPs
• Quick turnaround depending on clients’ needs
• Competitive Costs
• 100% approvals to date

PharmaLex is a leading provider of specialized services for the pharma, biotech and medical device industries.

We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval / maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions worldwide.

The PharmaLex Group now has over 1000 employees, with 33 offices in 21 countries and more than 600 satisfied clients worldwide.

• Development and maintenance of global regulatory product information
• Preparation of supporting documentation – clinical and non-clinical overviews, expert statements
• Alignment of CCDS with regional labels and vice versa
• Preparation of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and label for marketing authorization applications
• Literature searches
• Provision of labeling repository