TRANSLATION OF CLINICAL PROTOCOLS

GTS provides certified translation of clinical protocols into English, German, Spanish, Italian, French and other languages. Our clients are leading pharmaceutical companies, medical device companies, biotech companies and CROs. We can provide validated translation of clinical protocols with back translation. Click here to read an article with helpful information regarding back translation.

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). Some countries require that a translation of the clinical protocol be filed in order to conduct the clinical trial. Sometimes, it is sufficient to file a protocol synopsis.

If you would like further information, please email us at info@gts-translation.com . If a confidentiality agreement is required, please send us the document for signature and it will be returned within two days.