Patient Information Sheet Testing
As regulations covering the effective communication of information to patients increase, Aptiv Solutions is able to develop tailored solutions – including design, layout and multiple languages – for getting key points across to patients in an effective manner.
Aptiv Solutions offers clients across Europe patient information sheet testing solutions to meet their legal obligations and to improve patient adherence and safety by conducting tests on Patient or Package Information Leaflets (PILs) and other types of patient information.
Our experience covers Centralized, Decentralized, Mutual Recognition and National submission procedures, delivering reports that have been successfully submitted to most European agencies. We have tested products covering all major therapeutic indications and tested PILs for medical devices and instructions on packaging and labels.
Aptiv Solutions Product Information experts have experience in conducting both full tests and bridging studies on PILs for submission to European Regulatory Authorities.
Specific patient information sheet expertise exists for:
- Readability review (ensuring patient friendly language)
- Re-write of Patient Leaflets
- Design services for PIL mock-ups
- Translation services
- Testing in most European languages
