More clinical trials are conducted in multi-countries, such as Asia, Latin America, or Central and Eastern Europe. Even US-based studies recruit the majority of the subjects for clinical studies outside the US. Translation is required at many stages in bringing a drug to market, including regulatory submissions, clinical research, manufacturing, packaging and marketing. Erroneous translation can have exceptionally high indirect costs, leading to the delay of product commercialization, raising the possibility of litigation or rejection by regulators.
Our Translation Services
- Clinical Study Protocols
- Patient Reported Outcomes Forms (PROs)
- Informed Consent Forms (ICF)
- Clinical Study Agreements and Contracts
- Patient Diaries/Reports
- Instructions for Use (IFU)
- Clinical Study Report
- Patient Recruitment Materials
- Trial Close-out Monitoring Report
- Case Report Forms (CRF)
- Patient Guides
- Drug Development Process Documentation
Supported Languages
Simplified Chinese, Spanish, French, and all other major Asian and European languages.
Our ISO Certified Workflow
Our Advantages
Multilingual bio-medical terminology database.
Certified translators with professional degrees in biomedical sciences, chemistry, etc.
Final proofreading to ensure the perfection and reliability of the documents.
Project management simulators to ensure that deadlines are met without fail.
With more drug research conducted internationally, the need to translate clinical study agreements, contracts, protocols, publications, and submission materials for the U.S. FDA and other international regulatory authorities has grown exponentially. Our expert team can come up with a comprehensive approach and yield customized medical translation solutions. We can provide multilingual support to many application scenarios, serving clinical research organizations (CROs), pharmaceutical companies, and medical device manufacturers. We can also help to obtain approval from the NIH, the U.S. FDA, the HHS, global regulatory agencies, for health care providers seeking regulatory permissions of medical devices, pharmaceuticals and in vitro diagnostic products (IVDs). Translation services for reports, case studies and other documents related to clinical trials, will be done appropriately and accurately. You can completely rely on us for translation of your most sensitive documents.