Designing your study
We can advise on the best design for your study, depending on what stage of development your drug has reached. Doing Japanese studies in the UK helps sponsors satisfy PMDA requirements, allowing them to accelerate their early drug development programme and start studies in patients in Japan. We can also do simple PK/BE studies comparing the results of Japanese and Caucasian subjects. We offer you tailored advice on your study needs based on our extensive experience of doing Japanese trials and bridging studies in the UK.
Finding Japanese volunteers or those from other ethnic groups
Volunteer recruitment is always challenging, especially when recruiting from a small population. We always give sponsors a realistic and achievable timeline to recruit volunteers. We can advise you on the factors that will impact recruitment by assessing inclusion and exclusion criteria, restrictions and study design.
- study protocol
- information and consent forms
- investigator’s brochure
- IMP dossier
- case report form
Acting as your legal representative
Even if you don’t have a branch in the European Union, we can act as your legal representative for CTA applications in the UK.
Translating trial documents
We can translate trial documents from English to Japanese or other languages. All the documents that we give to Japanese volunteers are translated into Japanese. We translate documents into Japanese in-house because it’s quicker to do that than using an external company. Our volunteers are familiar with the style of our documents, including information and consent forms, that we’ve developed over the years. We back-translate Japanese to English to ensure the translation is accurate. We can provide you with a translation certificate.
Obtaining regulatory approvals
- Ethics Committee approval