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English Clinical Study Report (CSR) (See the figure above.)
Start to translate a Japanese protocol into English as soon as the Japanese clinical trial is initiated, and prepare an English CSR based on the completed English translation of the protocol and on the analysis results obtained after the database lock.
English CTD
MedicaLingual has a wealth of experience in the translation and medical writing tasks required for the preparation of all English 5 CTD modules, particularly with the medical writing tasks required for the preparation of Modules 2.5 and 2.7 (Clinical) and 2.4 and 2.6 (Non-clinical).
Japanese CTD Module 2.7.6 “Synopses of Individual Studies”
Prepare a Japanese CTD Module 2.7.6 “Synopses of Individual Studies” based on English CSRs.
Prepublication Paper (Japanese and English)
Prepare journal-quality Japanese- and English-language papers that are fully compliant with specific journal style and submission guidelines based on clinical and research data provided by the client.
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