When a corporation, federal agency, or other group is sponsoring a clinical trial, they are typically responsible for developing a thorough, detailed, and well-written clinical protocol. Clinical protocols are used to describe the direction and scope of the trial, research involved, and should explain how to analyze the results, as well as how the clinical trial is to be conducted. Ethics committees who oversee and review these trials must then survey each clinical protocol before a clinical trial is allowed to begin. Additionally, a set of internationally-accepted clinical guidelines and standards created by the International Conference on Harmonisation must be followed when preparing clinical protocols.
For each country where a drug is to be distributed or approved for marketing, a translated copy of the clinical protocol synopsis must be submitted to the country's regulatory, governing board for medicine. In the European Union, for example, a translated verysion of the clinical protocol (or a synopsis of it) needs to be submitted in that country's official language (or languages) to either the European Medicines Agency and/or the regulating authority for the member state.
Translations Services USA has over a decade of experience in medical translations, and a proven track record in the translation of clinical protocols and related documents into over 150 languages. Whether you represent a pharmaceutical company, a biotech company, or a CRO, and you are engaged in clinical trials to approve a new drug for sale internationally, we can provide a complete translation solution for your clinical protocols or clinical trial synopsis.
To request a quote or learn more about Translations Services USA's clinical protocol translation services, please contact us using our free quote request form.