Readability testing

Services Readability Test Pil – PIL user tests

Timeline:

– regular 6 -7 weeks 

– expedited 4 weeks (subject to additional fee)

Services :

– eCTD friendly dossier

– EMA and MHRA compliant reporting.
– Merging of all documents into 1 PDF for submission (m.1.3.4)
– Independent review of leaflet and mock-up.
– Rewriting of the leaflet upon request.
– Recruitment of 20 fresh – native users / consumers
– Preparation of protocol / questionnaire
– Arranging interview facility, all 20 interviews are held under the same conditions. Any disturbances are documented.
– Conducting of the interviews.
– Reporting within 2 weeks after fieldwork
– Printing of the mock-up in small batches
– Secure AVG / GDPR
– Documenting of individual detailed social demografic data of respondents (though not mandatory yet, we experience this is required by EMA and MHRA assessors more and more often).
– Documenting subjective ease of finding, PEI mandatory

Additional services:

Testing design

– Pilot testing of PiL or protocol

PIL/Mock-up
– Mock up design: we comply with all National Agency Specifications as well as your company’s design specifications
– Review of the Word text. Amendments are based on technical readabilitity, use of laymen terms, thousands of interviews etc. All in order to optimize readability (i.e. legible, clear and easy to use). Generally prioir to testing.
– PIL reformatting to current QRD
– 3D mock-up preparations

Bridging statements

Interested? Ask for quotation