In the life science industries, terminology management is an extremely important part of any localization project, as your project glossaries play a significant role in enabling the consistent translation of standard terms and messages across all of your key languages. Unlike a simple dictionary definition, a glossary is a necessary instrument for translators that eliminates any ambiguity while dealing with industry- or company-specific terminology and phrases, distinguishing analogous but non-identical terms with precision.
To help companies navigate this challenge and streamline the management of glossaries, CSOFT Health Sciences’ advanced terminology management systems (TMS) ensure that your brand, message, and content are received by your target audience exactly as you intended.
Ensuring Quality Translations with Terminology Management
Terminology management is extremely important in the life sciences, even outside translation. Inconsistencies in terminology and stylistic voice of the medical documents can confuse and 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 jeopardize regulatory compliance and put 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 result is uniform global market branding, saving you time, money, and energy.
Learn more about our automated terminology management system.
Regulatory Compliance and Terminology Management
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 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, many medical writers often author these documents from various demographic and geographic backgrounds, making the risk of using different terms and creating inconsistencies in the language much higher.
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 submissions, 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 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
Identify
In collaboration with your team, we identify key terms you will use with your product that need to be localized.
Extract
We identify legacy terms from other versions of your product and any associated documentation to determine their meaning.
Define
We then look at each term and determine how and when you should use it.
Import
We organize all your terms in a location where they are easily accessible (software, TMS, etc.).
Translate
We then translate terms or phrases into your target languages and verify their usage for consistency in various usages.
Assist
You can then share your collection with different groups that will be a part of the life cycle of your international product.
Quality Assurance
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 at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards. CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.
Learn more about our quality assurance process.
Data Security
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 the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.