Medical Translations

TOIN has been providing document services for more than half a century and has a wide range of experience in translation and writing. To facilitate the further globalization of our clients, we provide a full range of translation services in the medical field.



TOIN’s Strengths

In recent years, the evolution of research and technology in the field of medicine, including regenerative medicine, has been remarkable. Researchers from all over the world, transcending national borders, are engaged in friendly rivalry to promote various research, and new drug candidates are moving into clinical trials one after another. With the development of such research and technology, medical devices are becoming more sophisticated and precise, and the demand for high-quality, rapid medical translations is increasing.

1)Translator in specialized fields
We have translators for each field of specialization such as pharmaceuticals, medical devices, chemistry, legal affairs, etc.

2)Capacity
We have branches around the world and can provide native support.

3)Quality and number of translators
3,000 translators, registered after rigorous trials

4)Progress management
A dedicated project managers to provide production control of all projects.

5)DTP and engineering
We have DTP specialists and engineers in-house to provide comprehensive and efficient translation plans.


Types of documents we handle

[Life Science]
-CMC (chemistry, manufacturing, quality control)
Analytical method validation, project management, quality manuals, GMP (Good Manufacturing Practice) related documents, SOP (standard operating procedure), manufacturing records, DMF (drug master files), study plans, study reports, etc.
-Non-clinical studies: Animal experiments
Test plans, test reports, SOPs, articles and literature, etc.
-Clinical trials: Test with human subjects
Clinical trial notifications, investigational product summaries, study protocols, consent documents, case reports, SAE (serious adverse event) reports, study summary reports and supplementary tables, list of SAEs and concomitantly banned drugs, statistical analysis plans, DSUR (Development Safety Update Report, etc.
-Pharmaceutical affairs
PMDA (Pharmaceuticals and Medical Devices Agency) face-to-face advisory materials (clinical trial consultations, minutes), inquiries/responses, CTD (Common Technical Documents), case narratives, GCP (Good Clinical Research Practices) compliance checklists, pharmaceutical GCP on-site investigation results notifications, review reports, etc.
-Pharmacovigilance
CIOMS (International Council of Medical Societies Case Reports), literature and conference reports, PSUR (Periodic Safety Update Reports), PBRER (Periodic Safety Update Reports on Marketed Drugs), RMP (Risk management plans), CCDS (Corporate Core Data Sheets), SOPs, etc.
-Post-marketing surveillance
Post-marketing surveillance, use-results surveys, post-marketing clinical trials, re-examination and re-evaluation application materials, etc.
-Literature
Submitted articles, abstracts, conference presentation materials, attachment documents, product information summaries, press releases, etc.
-Medical devices
Medical device manuals, quality manuals, catalogs, device introduction videos, safety data sheets, websites, etc.

Quality Control and Security


In the CMC field, etc. especially, we use translation management support tools (Trados, Memsource, memoQ, etc.) to manage terminology and reliably accumulate translation memories for our customers’ translation projects. When we receive feedback from our customers about our translations and quality checks, we promptly reflect it in the translation memory to improve the quality of subsequent translations.
In addition, we implement the strictest measures for information security based on our own security standards in managing the manuscripts and materials we receive.


Languages
English <> Japanese
Deliverables
Investigational Drug Summary Clinical Trial Plan (Protocol) Case Report Overall Report Suspect Adverse Reaction Report (CIOMS Form, etc.) Application Related Document (IND, NDA, ANDA, etc.) Post-Marketing Safety Report (PSUR, etc.) Chemistry, Manufacturing and Controls (CMC) Material Safety Data Sheet (MSDS) FDA EMA Documents (CTD etc.) Other Clinical Trial Documents Medical Device Manual Presentation Material
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