Biopharmaceutical Clinical Labeling Case Study


2023-11-16 09:52 lionbridge


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Clinical labeling is a stringent, rigorous process that protects the health and well-being of trial participants. Procuring reliable, accurate, and efficient life sciences translation services is critical to maintaining compliance and meeting the tight deadlines required by regulatory bodies and the trial’s logistics. A particularly crucial element of clinical labeling is the Master English Label Text (MELT). The MELT must be created based on various essential clinical trial documents. It must also be tailored to different packaging types, including cartons, syringes, bottles, etc. The regional regulatory requirements for these labels vary frequently, requiring additional customization before these labels can be translated into the required target languages. Lionbridge has been helping a global biopharmaceutical company translate label phrases for its Investigational Medicinal Product (IMP) labels since 2016. Our customer, headquartered in the U.K., has extensive global reach. Its R&D focuses on several therapeutic areas, including infectious diseases and oncology. Lionbridge has assembled a team of life sciences translation and clinical trial translation experts, project managers, and cutting-edge technology to serve this customer. We’ve been helping them create compliant IMPs across many languages, including some that pose unique challenges. These languages include Hebrew, Japanese, Thai, and Korean. Lionbridge also developed a streamlined process for this BioPharma giant’s translation needs, particularly for its high frequency of rush orders. Using our deep domain expertise and technology-enabled processes, Lionbridge was able to deliver on projects, meeting quality standards and delivering 50% faster than initially agreed-upon timeframes. Discover how Lionbridge’s clinical trial translation services have supported our customer’s clinical labeling needs for almost a decade. Read the case study to learn about Lionbridge’s customized solution for a noted, global biopharmaceutical company.
临床标签是一个严格的过程,保护试验参与者的健康和福祉。获取可靠、准确和高效的生命科学翻译服务对于保持合规性和满足监管机构和试验后勤要求的紧迫期限至关重要。临床标签的一个特别重要的元素是主英文标签文本(MELT)。MELT必须基于各种基本临床试验文件创建。这些标签的区域监管要求经常变化,在将这些标签翻译成所需的目标语言之前,需要额外的定制。 自2016年以来,Lionbridge一直在帮助一家全球生物制药公司翻译其试验用药品(IMP)标签的标签短语。我们的客户总部位于英国,拥有广泛的全球影响力。其研发重点是几个治疗领域,包括传染病和肿瘤学。为了服务这一客户,Lionbridge组建了一支由生命科学翻译和临床试验翻译专家、项目经理和尖端技术人员组成的团队。我们一直在帮助他们创建跨多种语言的兼容IMP,包括一些带来独特挑战的语言。这些语言包括希伯来语、日语、泰语和韩语。Lionbridge还针对这家生物制药巨头的翻译需求开发了一套简化流程,特别是针对其频繁的紧急订单。借助我们深厚的领域专业知识和技术支持的流程,Lionbridge能够交付项目,满足质量标准,交付速度比最初商定的时间框架快50%。了解近十年来,Lionbridge的临床试验翻译服务如何为客户的临床标签需求提供支持。 阅读案例研究,了解Lionbridge为一家著名的全球生物制药公司提供的定制解决方案。