High-quality translation is a necessity when you are launching pharmaceutical products in a new market, providing treatment using the language a patient understands, or exporting medical devices. Life science companies need to ensure translations are accurate; otherwise, patients can be harmed, or the company may suffer legal or financial repercussions.
A potential mistake, such as typing the wrong unit of measurement for a drug dose, or omitting the word not, can have devastating results. This is why life science companies require translations to be done by translators who are subject matter experts, translation companies that follow proven processes to reduce and eliminate errors, and translation technology that enhances the work of all.
Life science and pharmaceutical industries are among the most heavily regulated in the world, so quality assurance is vital. Translators must understand the relevant industry and local regulations. International standards such as ISO 9001, ISO 27001 or ISO 17100 address translation quality and information security and are followed by prudent language service providers worldwide. European and national regulatory bodies also have specific translation terminology requirements.
What needs to be translated
1) Pharmaceuticals
To conduct scientific clinical trials and market drugs in other countries, pharmaceutical companies need a multilingual approach. A few examples of documents that need to be translated are Signed Agreements , Study Protocols and Amendments, Regulatory Authorities Documents, and Informed Consent Forms, among others.
2) Healthcare
Linguistically diverse populations need to receive critical health information in a language they can understand. To avoid dangerous consequences due to miscommunication, it is of utmost importance to translate documents such as informed consent forms, medical records, patient questionnaires, lab test results, hospital release forms, and aftercare patient instructions.
3) Medical Devices
To market medical devices, some countries, including the USA, require that companies conduct clinical trials. Pharmaceuticals and medical device companies both need proper terminology in translation for accuracy, understandability, and compliance with the various industry and international standards and regulatory obligations. Some examples of documents that need to be translated are Operating, Maintenance and Installation Manuals, Development Safety Update Reports, Instructions for Use, and Regulatory Compliance Documents, among others.
Tips for high-quality life science translations
1) Find the right translation partner
For life science companies, outsourcing to an experienced, trustworthy life science translation company is a must. The translation company, in turn, should assign professional, experienced translators with subject matter expertise to the project. Both partners should follow a process they believe will reduce errors and deliver a high level of quality. Translation tools can greatly enhance the efficiency and quality of work for all parties. Translation tools such as memoQ have a robust array of functionality including:
A state-of-the-art translation memory to automatically identify and re-use language repetition.
Terminology management to document terminology decisions and make them easily accessible to translators and reviewers.
Quality assurance modules to automate the process of finding and managing linguistic translation problems.
2) Establish a workflow for translation partnership
Life science companies and their translation company partners should establish a workflow that covers four important areas:
Assessing the project and answering initial inquiries.
Agreeing on preferred terminology for the project.
Assuring that the translation complies with the agreed upon standards and regulations, and that any questions or problems that occurred during the project are addressed.
The translation company should have similar arrangements with the translators selected for the project.
Accepting the scope, cost, and other agreements for the project.
3) Automate reporting
Reporting can be time-consuming. Both parties can save valuable project management time with automated reports and project templates. Automated reports in memoQ include analysis reports, progress reports, and post-translation analysis reports. Project templates also help automate project creation steps and other repetitive tasks. Templates can ensure that you adhere to a naming convention for projects and resources, making existing resources and projects easier to find and leverage for re-use.
Summary
Effective communication with a trusted translation partner that’s equipped with the right translation tools and services can expedite processes and produce high-quality life science translations.
当你向新市场推出药品,向病人提供易懂的治疗信息,或出口医疗设备时,高质量的翻译就是必需品。生命科学公司需要确保翻译的准确性,否则,患者可能会受到伤害,或者公司可能会遇到法律或财务问题。
一个潜在的错误,比如输错了药物剂量计量单位,或者漏掉了“非”这个字,都可能带来灾难性的后果。这就是为什么生命科学公司要求由专业的翻译人员进行翻译,要求翻译公司遵循经过检验的流程,减少消除错误,要求翻译技术提高所有人的工作效率。
生命科学和制药行业是世界上监管最严格的行业之一,因此质量保证至关重要。翻译工作者必须了解相关行业和当地法规。国际标准,如ISO 9001、ISO 27001和ISO 17100规定了翻译质量和信息安全,世界各地的语言服务提供商都谨慎地遵循这些标准。欧洲和各国的监管机构也有具体的翻译术语要求。
什么需要翻译
1)制药
为了进行科学的临床试验,并将药物销往其他国家,制药公司需要多语翻译。需要翻译的文件包括签署的协议、研究方案和修正案、监管机构文件和知情同意表格等。
2)医疗
多语言的聚居者需要他们能理解的语言,才能接收重要的卫生信息。为了避免由于沟通不畅造成的危险后果,知情同意书、医疗记录、患者问卷、实验室检测结果、出院表格以及患者的康复指导等文件的翻译便至关重要。
3)医疗器械
为了推销医疗设备,包括美国在内的一些国家要求公司进行临床试验。制药和医疗器械公司都需要正确的术语以保证翻译的准确性、易懂性,并符合各行业和国际标准和法律法规。需要翻译的文档包括操作、维护和安装手册、开发安全更新报告、使用说明和法律文件等。
提高生命科学翻译质量的小贴士
1)寻找合适的翻译伙伴
对于生命科学公司来说,将翻译外包给有经验、值得信赖的生命科学翻译公司是必然选择。相应的,翻译公司应该指派专业的、有经验的、熟悉该领域知识的译者参与项目。在项目过程中,双方都应共同努力,减少错误并提供高翻译质量。翻译工具可以大大提高各方的工作效率和质量,例如memoQ,功能强大,包括:
先进的翻译记忆,能自动识别、重复利用出现过的句对。
术语管理能记录术语处理,方便译者和审校查看。
质量保证模块,能自动发现并管理语言翻译问题。
2)为翻译合作建立工作流程
生命科学公司和他们的翻译合作伙伴公司应该建立一个涵盖四个重要领域的工作流程:
项目评估,初步调查。
确定项目的最佳术语。
确保翻译符合商定的标准和规定,确保解决项目期间发生的任何问题。
翻译公司对项目译者的安排不应差别过大。
接受项目的范围、成本和其他协议。
3)自动报告
写报告很耗时。自动化报告和项目模板可以为双方节省宝贵的项目管理时间。memoQ中的自动报告包括分析报告、进度报告和译后分析报告。项目模板可以自动创建项目步骤,完成其他重复性工作。模板确保你遵守项目和资源的命名规定,使现有的资源和项目更容易被发现和重复利用。
总结
与可信赖的翻译伙伴有效沟通,加上合适的翻译工具和服务,可以加快处理进程,产出高质量的生命科学译文。
译后编辑:孔越怡 (中山大学)
以上中文文本为机器翻译,存在不同程度偏差和错误,请理解并参考英文原文阅读。
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