To help companies navigate this challenge and streamline the management of glossaries, CSOFT Health Sciences’ advanced terminology management systems (TMS) ensures that your brand, message, and content are received by your target audience exactly the way you intended.
Ensuring Quality Translations with Terminology Management
Terminology management is extremely important in the life sciences, even outside of translation. Inconsistencies in terminology and stylistic voice of the medical documents can cause confusion as well as impact the product’s overall quality. Poor quality terminology can further lead to extra rounds of revisions, sacrificing time and potentially a substantial amount of money to resolve these errors. In the life sciences, this issue is even more pertinent, as terminology errors can lead to jeopardizing regulatory compliance as well as putting a patient’s health and safety in danger.
That is why CSOFT Health Sciences provides our very own, and first of its kind, terminology as a system, that allows life science organizations to effectively manage their terminology collaboratively. The end result is uniformity of branding for the global market, also saving you time, money, and energy.
Learn more about our automated terminology management system.
Regulatory Compliance and Terminology Management
The life sciences are a highly regulated industry, with government agencies overseeing the development of medical products and services in practically every country. Globally, these agencies require submissions for all types of medical documents pertaining to the medical product or clinical study, like clinical trial protocols, medical device user manuals, licensing applications, and even medico-marketing materials. Given the volume of documents needed for regulatory submission, there are often many different medical writers that author these documents from various demographic and geographic backgrounds, making the risk of using different terms and creating inconsistencies in the language much higher.
The importance of consistent and accurate terminology is vital for the medical product’s success in the market. Terminology management is an easy way for medical writers to collaborate on regulatory submissions, including CTD/eCTD regulatory submission, without the fear of inconsistencies in voice and vocabulary. To help companies navigate the regulatory submission and approval process, CSOFT Health Sciences delivers effective terminology management solutions for a wide range of regulatory documents, including IRB correspondence translations, TMF/eTMF translations, investigator’s brochure (IB) translations, and international patent translations.
Learn more about our full range of regulatory document translations.
In addition to our translations for all types of life science regulatory documents, you can read more about the importance of terminology management for regulatory submission from our recent white paper.
Steps to Success: How CSOFT’s Terminology Management Works
What are the key terms you will use with your product that you need localized?
Utilize legacy terms from other versions of your product and any associated documentation and determine what it means.
Look at each term and determine how and when you should use it.
Gather all your terms together in an organized location where they can be easily accessible (software, TMS, etc.)
Translate terms or phrases into all of your target languages and verify their usage for consistency in various usages.
CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time. Every step of the way, CSOFT has you covered.
Learn more about our quality assurance process.
With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.