Clinical Study Report Translation
It takes a lot of careful work for a successful clinical trial. The process takes years and the participation of hundreds of people, as well as careful attention to detail and scientific rigor, which must be accurately reflected in the clinical study report. Translation can be a critical component of this process.
A clinical study report, also known as a CSR, is a detailed scientific report that describes a clinical trial’s methods, design and results, including gathered data and treatment details, in the interests of safety and efficacy. These reports are submitted to national regulators, such as the US Food and Drug Administration (FDA), when applying for authorization to market and distribute a drug or medicinal product for human use.
CSRs for International Use
There can be important financial benefits to distributing a drug or medicinal product in multiple markets. However, that entails interacting with multiple regulatory agencies. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (known as ICH) has the most widely-used guidelines on writing clinical study reports for use in the United States, Europe and Japan.
In addition, the ICH’s guidelines have been adopted by most regulatory agencies worldwide. Where are you planning to go to market? We have experience translating content for clinical study reports destined for a variety of regulatory markets.
Experts in Clinical Study Report Translation
For more than 20 years, Responsive Translation’s team has been providing high-quality, high-stakes translation to clients in the US and around the world. We bring years of experience to our specialty: rapid, accurate and cost-effective translation for clinical trial communication requiring strict compliance and quality assurance. Responsive Translation’s services include clinical subject matter expertise and custom workflow design for guaranteed satisfaction and the best quality assurance processes around.
To discuss your specific translation requirements, or to receive more information about Responsive Translation’s suite of clinical trial translation services, please contact us at +1-212-355-4455 or firstname.lastname@example.org.