Synopses are some of the most important clinical trial documents. Whether shared as part of the grant process, regulatory approval process or afterwards to advance public health, clinical trial synopses provide an important snapshot about a specific clinical research study. They include clinical trial protocol synopses and clinical study report (CSR) synopses. Specialist translation teams and workflows are required to correctly and efficiently translate synopsis detail. Investigators have enough details to keep track of that translation should be trouble free.
What Does a Synopsis Include?
Synopsis content can vary from study to study and format to format. For example, the University of California, San Francisco recommends that a clinical trial protocol synopsis contain the following information: the title, clinical study sponsor, funding organization, number of sites involved, study rationale, study design, primary objective, secondary objective, number of subjects involved, subject selection criteria, test product and dose, route of test product administration, control product and dose, route of control product administration, how long subjects will participate in the study, how long the study will last, allowed and prohibited medications, efficacy evaluations for primary and secondary endpoints, safety evaluations, interim analyses, statistical analysis plan and rationale for number of subjects.
For a clinical study report (CSR) synopsis, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) simply recommends that the clinical research study be summarized in a maximum of three pages and contain numerical data.
Getting it correct in whatever language used for your study is not a trivial problem.
The Need for Translation
There are many reasons to translate a clinical trial synopsis, including pursuing grant funding, seeking regulatory approval in other markets, and sharing clinical trial results with other researchers or the public. In every case, clinically-accurate, culturally-appropriate translation is of paramount importance; when it comes to your audience, the right translation can mark the difference between clinical trial failure and success.
Experts in Clinical Trial and Synopsis Translation
Responsive Translation has been providing high-quality translation and review services for more than 20 years. We specialize in high-stakes, compliance-intensive translation with an emphasis on rigorous quality assurance and custom workflows. Our specialist translators, reviewers and subject matter experts bring decades of experience and a triple-check process to every project. For these reasons, Responsive Translation is uniquely qualified to contribute synopses translation of the highest caliber.
In addition, our combination of know-how and dedication to service has earned us the highest rate of customer satisfaction among language service providers worldwide with a Net Promoter Score of 94 in 2016, as audited by the British Standards Institution. We would love to show you what we can do.
If you would like to discuss your specific translation and review requirements, or receive more information about Responsive Translation’s range of clinical trial translation services, please contact us at +1-212-355-4455 or email@example.com.