Translation of Clinical Protocols
GTS Translation provides a complete translation solution for pharmaceutical companies, biotech companies and CROs that are engaged in clinical trials for approval of a new drug. This includes certified translation of clinical protocols into all EU languages, as well as most Asian languages.
A detailed clinical protocol is usually developed by the sponsor for each clinical trial. The clinical protocol describes the purpose of the research, explains how the trial will be conducted and how the results are analyzed. An ethics committee must review the protocol before the trial can begin. Protocols are prepared in accordance with the internationally accepted good clinical practices guidelines developed by the International Conference on Harmonisation (ICH).
Translation of a clinical protocol synopsis is usually required for regulatory submission in each country where the drug is to be approved for marketing. Translation of the clinical protocol or a synopsis of it must be submitted to the European Medicines Agency (EMA) or to the authorities of the member state in all relevant languages.
GTS has proven experience in translation of clinical protocols and clinical protocol synopses into all EU languages. Customers include: AstraZeneca, Teva Pharmaceuticals, NYU Langone Health, Cardionomic, Novartis and Johns Hopkins University School of Medicine.