SCOPE 2023 Wrapped-Up: Life Science Translations

范围2023总结:生命科学翻译

2023-02-15 17:03 Morningside

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Under the warm sun and surrounded by palm trees, clinical leaders from around the world reunited at SCOPE 2023 and met with Morningside about Life Science Translations. From Feb 6-9, the 14th year of SCOPE brought together over 2,300 leaders in clinical operations and research to Orlando, Florida, at the Rosen Shingle Creek, where programs focused on advances and innovative solutions in clinical trials, planning, management, and operations. The SCOPE of it Our experienced Morningside Life Science translations team had the opportunity to reconnect with old partners and meet with many new faces this year at SCOPE. It was refreshing to talk with everyone face-to-face, learn about clinical operations and research teams’ challenges, and better understand your needs. Bringing a drug to market can be long and costly, from discovery to delivery. Translations are required at various product lifecycle stages, including clinical research, regulatory submissions, labeling, and marketing & commercialization. We know how costly translation errors can be, which may lead to delays in time-to-market, so our rigorous quality controls are certified to the latest ISO 9001, 13485, and 17100 standards. We had the chance to introduce attendees to the extensive language expertise we provide and how we can help alleviate your pains with services such as; Clinical Translation and Validation – Elevate your standards of accuracy and achieve better outcomes. Regulatory Translation – Meet local regulatory requirements and gain swift approval from the EMA, FDA, CFDA and PMDA. Medical Interpretation – Reduce the risk of miscommunication with specialized medical interpretation Marketing and Commercialization – Make your go-to-market plan a success with culturally relevant promotional and educational materials. Intellectual Property – Gain international protection for your IP with cost-effective patent translation and foreign filing services. We equip the world’s leading life sciences organizations with a full suite of end-to-end language solutions for regulatory, clinical, commercial and patent needs. With over 4,000 clients in 55 countries, we’re globally recognized for our life science expertise and technology innovation across pharma, biotech, medical devices, and healthcare. Our life sciences translation services ensure your products and ideas can seamlessly reach new markets and comply with all regulatory and cultural requirements through every stage of the product lifecycle — from patent to post-market. While at SCOPE we helped advise on how our translations done by subject matter experts help save time and money on your translation needs and help you reach your goals. Quality is at the heart of what we do and our primary focus. Our commitment to quality spans every stage of the project lifecycle, from initial request through on-time delivery. It’s why we’re trusted by leading organizations to translate over 400 million words a year and file over 18,000 patents around the globe. Our Quality Management System (QMS) is certified to the latest ISO 9001, 13485, and 17100 standards, and is independently audited to ensure compliance. Over the past 20 years, we have worked tirelessly and continuously to improve our processes – from the rigorous vetting and onboarding of translators and subject matter experts to our proprietary Quality Reliability Indicator (QRI) algorithm and post-production audits. Each process includes built-in redundancies and is supported by industry-leading technology to mitigate risk and ensure error-free deliverables. Whether you are facing issues getting your ICF, CRF, or Patient Recruitment materials translated into your targeted languages or finding interpreters to assist in adverse severe event calls, we spent significant time informing clinical operations teams and researchers that they could rely on Morningside to equip themselves to overcome any language challenges they face. We want to reassure you that you can trust in the quality of our translations, knowing Morningside is ISO 9001:2015, 13485:2016, and 7100:2015 certified, ensuring high-quality translations every time! If you want more Life Science Translations after SCOPE 2023: If you didn’t get a chance to stop by our booth to learn about our language solutions, our experts are still available for consultations. If you did get to stop by to speak with our Morningside experts, we know you walked away with the information you need to help solve your business’ language solution needs. Contact us today for your language service needs. Morningside, a Questel Company, provides reliable pharmaceutical translation services for every stage of the product lifecycle. In the discovery stage, drug and biotech companies rely on us to help patent and protect their ideas abroad. Sponsors and CROs partner with Morningside during the clinical stage to plan their budgets, translate their documentation and validate their COAs. In preparation for regulatory approval, we provide translation services for a range of regulatory documentation from labeling, packaging, and IFUs, to EC/IRB Correspondence, NDAs and INDs. Finally, when it is time to enter foreign markets, we localize and culturally adapt marketing materials, websites, eIFUs and eLearning modules. To round out the product lifecycle, we provide translations for post-market adverse event reporting.
在温暖的阳光下,在棕榈树的环绕下,来自世界各地的临床领导者在SCOPE 2023上重聚,并与晨兴会面,讨论生命科学翻译。从2月6日至9日,第14年的SCOPE将2300多名临床运营和研究领域的领导者聚集在佛罗里达州奥兰多的Rosen Shingle Creek,在那里,项目侧重于临床试验、规划、管理和运营方面的进步和创新解决方案。 它的范围 我们经验丰富的晨兴生命科学翻译团队今年有机会在SCOPE与老合作伙伴重新联系,并会见了许多新面孔。与每个人面对面交谈,了解临床操作和研究团队面临的挑战,并更好地了解您的需求,令人耳目一新。 从发现到交付,将药物推向市场可能是漫长而昂贵的。产品生命周期的各个阶段都需要翻译,包括临床研究、法规提交、标签以及营销和商业化。我们知道翻译错误的代价有多大,这可能会导致上市时间的延迟,因此我们严格的质量控制通过了最新的ISO 9001、13485和17100标准的认证。 我们有机会向与会者介绍我们提供的广泛的语言专业知识,以及我们如何通过以下服务帮助减轻您的痛苦: 临床翻译和验证–提升您的准确性标准并获得更好的结果。 法规翻译-满足当地法规要求,并迅速获得EMA、FDA、CFDA和PMDA的批准。 医学口译-通过专业医学口译降低沟通不畅的风险 营销和商业化–使用与文化相关的宣传和教育材料,使您的上市计划取得成功。 知识产权–通过经济高效的专利翻译和国外申请服务,为您的知识产权获得国际保护。 我们为世界领先的生命科学组织提供全套端到端语言解决方案,以满足监管、临床、商业和专利需求。我们在55个国家拥有4,000多家客户,我们在制药、生物技术、医疗设备和医疗保健领域的生命科学专业知识和技术创新得到了全球认可。我们的生命科学翻译服务确保您的产品和创意能够无缝到达新市场,并在产品生命周期的每个阶段(从专利到上市后)符合所有监管和文化要求。 在SCOPE期间,我们帮助建议主题专家如何为您的翻译需求节省时间和金钱,并帮助您实现目标。质量是我们工作的核心,也是我们的首要关注点。我们对质量的承诺跨越项目生命周期的每个阶段,从最初的请求到按时交付。这就是为什么我们受到领先组织的信任,每年翻译超过4亿个单词,并在全球申请超过18,000项专利。 我们的质量管理体系(QMS)通过了最新的ISO 9001、13485和17100标准认证,并经过独立审计以确保合规。在过去的20年里,我们孜孜不倦地不断改进我们的流程——从翻译人员和主题专家的严格审查和入职,到我们专有的质量可靠性指标(QRI)算法和后期制作审计。每个流程都包括内置冗余,并由行业领先的技术支持,以降低风险并确保无错误的交付。 无论您是在将ICF、CRF或患者招募材料翻译成目标语言时遇到问题,还是在寻找翻译来协助不良严重事件呼叫时遇到问题,我们都花了大量时间通知临床运营团队和研究人员,他们可以依靠晨兴来装备自己,以克服他们面临的任何语言挑战。 我们想向您保证,您可以信任我们的翻译质量,知道晨边是ISO 9001:2015、13485:2016和7100:2015认证,确保每次都有高质量的翻译! 如果你想在SCOPE 2023之后得到更多的生命科学翻译: 如果您没有机会参观我们的展位,了解我们的语言解决方案,我们的专家仍然可以提供咨询。如果您有机会与我们的晨边专家交谈,我们知道您带走了帮助解决您企业语言解决方案需求所需的信息。如果您需要语言服务,请立即联系我们。 Questel公司Morningside为产品生命周期的每个阶段提供可靠的药物翻译服务。在发现阶段,药物和生物技术公司依赖我们在国外帮助申请专利和保护他们的想法。赞助商和cro在临床阶段与晨兴合作,规划他们的预算,翻译他们的文件并验证他们的COAs。在准备监管批准的过程中,我们为一系列监管文件提供翻译服务,从标签、包装和IFU,到EC/IRB信函、NDA和IND。最后,当需要进入国外市场时,我们会对营销材料、网站、eifu和电子学习模块进行本地化和文化调整。为了完善产品生命周期,我们提供上市后不良事件报告的翻译。

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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