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Translation of Clinical Protocols

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. Please contact us for a price quote or for any questions regarding clinical protocol translation services.



Google Rating
4.9

Customer Recommendations

max hasson
max hasson
18:10 10 Dec 16
Rapid quote and quick turn around. Fully satisfied with the results.
Gina Davis
Gina Davis
19:28 10 Aug 16
Loved the service and turnaround time with this company. They quickly got to know our needs (specifically for a back translation and validated translation for a research project with two languages), and though we inundated them with several additional requests through the project, all was handled professionally and with ease. Highly recommend.read more
John-Paul McMahon
John-Paul McMahon
15:01 17 Nov 16
A fantastic service and great staff. I am very pleased. They were the best translators that I have worked with.read more
Mark McKinnon
Mark McKinnon
18:44 07 Dec 16
Quick, efficient translation service who took my requirements and context into account. Would recommend.read more
Carlos Maza
Carlos Maza
11:35 23 Oct 16
Great customer service and fulfillment of agreed timelines. Very personal service. Would highly recommend them!read more
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