June 2017
Oracle Translation provided Siemens Ltd. with localization services for medical device manuals, technical documents, and installation and maintenance manuals.
As a professional translation service provider with nearly 15 years of experience in the bioscience and medical industries, our life sciences translation project team includes translators with deep subject-matter expertise, a comprehensive quality assurance system, and extensive hands-on project experience, fully meeting the rigorous academic requirements of the life sciences and medical fields. In addition, we obtained ISO 9001 Quality Management System certification and ISO 17100 international translation quality certification in 2016, and became a member of the Translators Association of China and the American Translators Association in the same year. To date, we have provided language services to many well-known biotechnology and medical technology companies in China and abroad, and have established long-term partnerships with multiple Fortune Global 500 companies, including Pfizer, Sanofi, Siemens Healthineers, Novartis, and GE Healthcare, providing translation and localization services for technical documents, registration submissions, and other materials related to products launched in the Chinese market.
Including medical device manuals, instructions for use (IFU), installation manuals, user manuals, and medical device graphical user interfaces (GUI).
Including experimental reports, surgical equipment patents, and regulatory documents for equipment manufacturing.
Including medical seminars and summits, advertising and website promotional materials, educational and training materials, and related literature.
Product characteristics, quality standards, manufacturing processes, process validation, method validation, stability studies, pharmacological studies, pharmacodynamic studies, toxicological study reports, pharmaceutical patent application materials, IND/NDA/BLA/ANDA submissions, new drug application dossiers (including certification materials for CE, FDA, CFDA, etc.), and application-related materials for traditional Chinese medicine, etc.
Clinical study protocols, investigator's brochures, clinical study reports, patient-reported outcomes (PRO), CRFs, ICFs, ethics committee approvals, safety study reports, clinical literature, etc.
Case Report Forms (CRF), electronic Case Report Forms (eCRF), clinical trial authorizations, investigator's brochures, investigational drug labels, and other clinical documents.
Informed Consent Forms (ICF)
Patient Information Sheets (PIS)
Patient Safety Cards
Clinical trial authorization documents, patient diaries, and electronic diaries
We have a professional customer service team composed of localization engineers, project managers, translators, and QA specialists. Each member has expertise in fields such as biology and healthcare, enabling us to meet clients' diverse and specialized translation needs. Before a project officially begins, a dedicated one-on-one customer service manager will communicate directly with the client to fully understand their requirements, learn from the client's previous project experience, strive to maximize satisfaction, and provide an excellent collaboration experience.
High-caliber language professionals are a strong guarantee of high-quality translation services. In addition to our full-time translators, we continuously recruit multilingual talent through cooperation with leading universities in China and abroad via various channels, while providing unified professional training and management. New talent may enter our multilingual talent pool only after passing dual assessments in language proficiency and professional ethics. In addition, we advocate the principle of "letting professionals do professional work" and have established a dedicated translation project team for the life sciences and medical industries. Over the course of long-term service delivery, this team has accumulated extensive terminology resources and translation experience, and has built a specialized industry termbase containing more than 30,000 terms, enabling us to fully meet client needs.
Our translation project team uses CAT (Computer-Assisted Translation) technology to create translation memories from previously translated content and organize them for flexible use across different translation projects, thereby effectively reducing translation time. At present, we have widely applied CAT technology in large-scale text translation projects, significantly improving overall translation quality while maintaining consistency in language style and terminology. Another advantage of CAT tools is that they can preserve the original file format, such as FrameMaker and QuarkXPress, thereby avoiding the substantial time required for re-typesetting multilingual content, effectively reducing translation costs and improving efficiency.
We implement a strict five-stage quality control procedure and a three-tier review system. After each translation project is completed, the project manager promptly arranges the review process. Reviewers then revise the text for terminology accuracy and language fluency. Finally, the project manager conducts a full read-through before final delivery. Through multiple layers of review and refinement, we ensure the flawless communication of your product features and brand value.
Before translation begins, our project team will establish a dedicated termbase based on the glossary provided by the client. Translators then follow this termbase strictly when translating specialized terminology to ensure the most accurate rendering of the source text. Finally, senior reviewers conduct rigorous quality control, proofreading the translation word by word and sentence by sentence against the original, and revising and polishing it in terms of faithfulness, expressiveness, and elegance. This ensures that the translation remains true to the original while meeting industry requirements and the linguistic characteristics of the target language.
Supported by cutting-edge technology, we can directly edit and translate all common file formats. Meanwhile, our tightly integrated workflow can significantly reduce costs, lower error rates, and shorten typesetting time. This includes tasks such as adjusting the translated layout according to the source document's layout; adjusting and replacing charts; creating tables of contents, indexes, and cross-references; and editing special characters.
In addition to translating DTP and Office-format files, our flexible and professional translation team is also capable of handling Adobe files, graphic formats, CAD formats, as well as export formats from CMS, PIM, ERP, TYPO3, WinCC, and other CMS platforms. Our desktop publishing team works closely with graphic design review specialists and uses a comprehensive font library to process files and applications in a wide range of formats, helping you convert source-language files into print-ready files in more than 170 languages.
Our service processes follow the ISO 17100 and ISO 9001 quality management systems and strictly comply with the requirements of ATA and LISA (localization standards). Our expert team and quality control specialists work closely with your team to deliver texts to global clients that are precise and consistent in terminology, detailed in content, and fluent in expression.
Oracle Translation fully understands the importance of information security. Throughout our cooperation, we implement rigorous processes and strict confidentiality measures to safeguard the security and privacy of your content across the entire project lifecycle. We hereby state that any product content, technical patents, documents, drawings, equipment manuals, and other materials involved in the translation services we provide are the intellectual property of the client, and the client retains the copyright to the translated documents. We must not disclose any content of the translation materials to any third party without authorization. In addition, we sign confidentiality agreements with both our clients and all employees, and enforce a strict internal confidentiality system. We have established tiered confidentiality plans and security measures, including network-isolated monitoring and secure USB drives. From the very beginning of the workflow, dedicated personnel are assigned to each stage to prevent any form of information compromise or leakage.
| Name | AM-Wang | Age | 46 | Title | Senior Reviewer |
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Main Qualifications and Project Experience: Graduated from the Department of Microbiology at Fudan University, Shanghai, in July 1996; English-to-Chinese translation of the technical manual for BD's "Single-Use Arteriovenous Indwelling Catheter Production Line" project; Chinese-to-English translation of technical documents for "Critical Care Monitoring and the Application of Automated External Defibrillators (AEDs)"; Chinese-to-English translation of technical documents for the "China Hospital Management and Holistic Nursing Seminar"; English-to-Chinese translation of project documents for Baxter's "Baxter Fully Closed Infusion Bag" project; Chinese-to-English translation of the technical manual for "The Application of Computer Integrated Systems in Medical Ventilators"; Chinese-to-English translation of documents for the "China Hospital Management System (HAS) and Computerized Automatic Logistics Conveyance System"; English-to-Chinese translation of FDA project documents on food safety, food poisoning detection, and emergency response; English-to-Chinese translation of operational procedure documents for U.S. FDA Investigational New Drug (IND) review |
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| Year of Service | Major Projects Participated In | Remarks | |||
| 2014-2017 | Translation of specialized documents for the joint meeting between the State Food and Drug Administration, the U.S. FDA, and the European Medicines Agency; translation of technical materials for the operational procedures of U.S. FDA Investigational New Drug (IND) review, etc. | Recognized by the relevant departments of the State Food and Drug Administration and the FDA | |||
Translation Consulting
Translation Consulting