Clinical and regulatory client documentation has been much of the work we do in life sciences translation at Tradu24. Our knowledge of serving this community covers every aspect of the global medical and pharmaceutical business needs, including translation of all types of clinical trial documentation in all languages.
|Clinical Trial Protocols||Informed Consent Documentation|
|Case Report Forms||Patient Information Sheets|
|Scales||Life Sciences Translation Questionnaires|
|Serious Adverse Events||Lab Reports|
|Labeling and Packaging||Chemical Fact Sheets|
|Medical Device Manuals||Life Sciences Translation Marketing Materials|
|Patient Information||Life Sciences Translation Patents|
Global Regulatory Submissions
Whether you are registering across all EU languages with the European Medicines Agency (EMA), or a select number of languages with local health authorities in China (SFDA), Japan (PMDA), and Korea (KFDA), for example, Tradu24 supports a broad range of multilingual regulatory needs from translation to desktop publishing to XML engineering and independent review. Our experienced and dedicated Global Regulatory Submissions’ team is there to help you meet rigorous multilingual filing requirements, from turnaround time to quality. Read more.
Medical Device Labeling
International regulations require medical device companies to localize their product labeling, including software, user manuals, instructions/directions for use, and labels, into an ever-increasing number of languages (average between 17 and 22 languages depending on the device markets). The Tradu24 professional team members have long-term experience and a deep understanding of the unique challenges of medical device labeling localization. From initial product labeling submissions to the labeling of the final product , Tradu24 can help you achieve your worldwide localization goals.
Clinical Trial Documentation
Tradu24 is specialized on the translation of clinical trials by providing full linguistic validation and cognitive debriefing, with a well-structured ISPOR, ISOQOL, and EORTC compliant methodology to ensure the highest quality standards for multilingual translation. Our dedicated clinical team can scale programs to support clinical trials of all sizes and number of countries. Today, we are supporting some of the world’s largest clinical trials, with more than 5,000 participants in 15+ countries.