The goals of the PIL readability testing is to verify that the users can easily locate and understand the PIL information, and can explain it in their own words.
Each PIL is studied individually according to its own protocol.
The protocol includes the design of the interviewing methodology to target users, according to the drug in study.
Four pilot interviews are conducted and subsequently, at least 20 more interviews, depending on the results more interviews may be conducted.
Oral interviews last about 30 minutes. Our experienced professionals ask 12-15 questions in a comfortable and relaxed atmosphere.
Questions focus on what the drug is used for, how it is used and side effects.
The final report includes a description of the test, analysis of the data and expert recommendations.
Our team is composed of:
Doctors + Pharmacist + psychologists + sociologist + linguists + users.
How we organize our work:
1 Before the test:
Prepare a protocol.
Review the PIL and make recommendations to improve its readability.
Develop a questionnaire with answering sheet to be used Turing the interview.
Recruit target patients.
Conduct pilot interviews.
2 During the test:
Experienced professionals conduct interviews according to a specific protocol tailored for each PIL. Recruit a minimum of two groups of 10 participants each.
3 After the test:
Evaluate the results.
Make recommendations on the PIL base don the test's findings.
Prepare a final report for the health authorities.
A PIL is easy to read because of its size, colour, font type and clear content.
PIL readability is confirmed by the user PIL testing as required by Spanish RD 1345/2007 which transposes Directive 2004/27/EC of the European Parliament and the Council of the European Union.
Our experience and expertise will help reduce your workload and allow you to devote your time to other sections of the dossier.
Consider Actiomed for your PIL testing needs. We offer personalized and reliable service working as a team with the client.
We provide high quality service guaranteed by experienced professionals, according to Standard Operation Procedures.
We work within reasonable budgets and meeting deadlines is a priority for us.
Check out our brochure 
