Introduction
Global clinical trials, for example, depend heavily on the ability to communicate effectively with participant groups, regulatory bodies, and stakeholders around the world. The complexity of these trials is compounded by the need to manage vast amounts of data, documents, and reports that must be accurately translated to meet the regulatory requirements of different countries.
This is just one example of how life science companies are increasingly turning to translation management systems (TMS) to streamline the translation process and maintain high content quality. A TMS facilitates an efficient end-to-end translation process, enabling companies to keep pace with the demands of global operations while ensuring accuracy and compliance.
Three essential benefits of a TMS that are particularly valuable for life science companies include accuracy, quality and timing. A good TMS will provide for all three of these vital needs.
Integrating these within a TMS gives life science companies a powerful tool for managing their translation software. Companies can achieve streamlined translation processes, ensure regulatory compliance, maintain consistency in terminology, and improve timing.
This results in high-quality translations that support the critical work of the life science industry in developing, testing, and bringing new treatments and products to a global audience.
Accuracy: Compliance with Regulations
Translations are useless without accuracy, and there are few subjects more important than regulatory requirements. Compliance is about ensuring that every piece of translated material meets the exacting standards set by regulatory bodies worldwide. This safeguards the efficacy, safety, and marketability of life science products across different regions.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), including the Good Clinical Practice (GCP) guidelines, is a standout among these regulatory frameworks.
Accuracy in compliance with such standards is necessary for conducting international clinical trials and for the approval and commercial distribution of new pharmaceuticals and medical devices.
The challenge of accurate compliance with regional and international regulations is compounded by the inherent instability of these standards. They evolve over time, responding to new scientific discoveries, technological advancements, and shifts in public health policies.
For life science companies, this means constant vigilance and adaptability are required to stay abreast of and comply with these changes.
A good TMS has a suite of tools specifically designed to handle the regulatory landscape efficiently and effectively. A TMS can substantially ease the burden of accurate compliance through several key features:
Centralized Document Management
A TMS provides a centralized platform for storing, managing, and tracking all documents related to translation projects. All team members work from the latest versions of documents, reducing the risk of errors that could result from using outdated information.
Maintaining comprehensive audit trails of all changes made to a document is critical for regulatory compliance. Audit trails enable companies to demonstrate the accuracy and integrity of their translations.
Automated Workflow Features
Efficient workflow management is key to the timely and effective completion of translation projects. A TMS with automated workflow features can route documents automatically for translation, review, and approval by qualified experts.
This streamlines the process so that each step is completed by the appropriate team members and that no critical steps are overlooked.
Automation also facilitates the involvement of subject matter experts and qualified translators familiar with the target market’s specific regulatory requirements. Their expertise helps translations meet the linguistic and cultural expectations of the target audience and also comply with regulations.
The combination of these features in a TMS represents a perfect solution for life science companies. Centralized document management ensures consistency and traceability, integration with regulatory databases guarantees the use of correct terminology and formats, and automated workflow features streamline the entire translation process.
Together, these tools enable life science companies to produce high-quality translations that meet the rigorous standards of regulatory bodies worldwide.
Quality: Mastering Medical Terminology
Even with acccuracy and appropriate attention to regulations, the underlying quality of the translations are fundamentally important in life sciences. The stakes in medical communication are extremely high, where low quality and errors can lead to misunderstandings with potentially grave consequences. This is particularly true in clinical trials, regulatory submissions, and patient care information.
The importance of consistent terminology in creating quality translations cannot be overstated, as it ensures the safe and effective use of medical products and interventions across linguistic and cultural boundaries.
The Challenges of Medical Jargon
Medical jargon is vast and complex, characterized by many terms that often have very specific and nuanced meanings. Synonyms within medical terminology add another layer of complexity, as different terms may be used to refer to the same condition or procedure. There might also be regional variations in medical terminology, where different terms might be used in different countries or regions, even when the same language is spoken.
These quality challenges necessitate a rigorous and systematic approach to terminology management in life science translations.
With advanced terminology management tools, a TMS enables creating and maintaining customized glossaries tailored to each translation project’s needs. These glossaries are a central repository of approved terms, so translators use consistent terminology across all documents related to a project.
This is especially critical in large-scale projects involving multiple translators or translation teams, as it helps maintain uniformity and prevents discrepancies in the use of medical terms.
A TMS with these capabilities transforms the daunting task of managing medical terminology into a more manageable and systematic process. By building customized glossaries, integrating with authoritative terminology databases, and employing machine translation judiciously, life science companies can significantly enhance the accuracy and consistency of their translations.
This facilitates compliance with regulatory requirements and supports the ultimate goal of ensuring patient safety and effective communication in the global marketplace.
With advanced terminology management tools, a TMS enables creating and maintaining customized glossaries tailored to each translation project’s needs. These glossaries are a central repository of approved terms, so translators use consistent terminology across all documents related to a project.
Timing: Reducing Delays and Accelerating Time-to-Market
In the fast-paced life sciences industry, time is of the essence. Delays in translation can have significant consequences, from impeding clinical trial timelines to hindering regulatory submissions and delaying the launch of critical products. A TMS specifically designed for life sciences can reduce delays and accelerate time-to-market.
Streamlining Workflows for Efficiency
A TMS acts as a centralized hub for all translation activities, eliminating the need for manual handoffs and scattered communication. This streamlined approach ensures that tasks are seamlessly assigned, tracked, and completed, minimizing bottlenecks and delays. Automated workflows within the TMS further expedite the process by routing documents to the appropriate linguists, subject matter experts, and reviewers, ensuring that projects progress smoothly and efficiently.
Leveraging Technology for Speed
Modern TMS platforms leverage advanced technologies to enhance translation speed. Machine translation engines, integrated with the TMS, can provide initial drafts of translations, which can then be refined by human linguists. This significantly reduces the time required for manual translation from scratch. Additionally, TMS platforms often offer translation memory capabilities, which store previously translated segments for reuse. When similar content arises in new projects, the TM suggests matches, accelerating the translation process and ensuring consistency across documents.
Real-Time Collaboration and Communication
Timely feedback and collaboration are crucial for preventing delays in translation projects. TMS platforms facilitate real-time communication among linguists, SMEs, and project managers through built-in messaging, commenting, and annotation tools. This allows for quick clarification of any ambiguities or questions, ensuring that potential issues are addressed promptly and do not impede progress.
Quality Assurance for Accuracy and Efficiency
A TMS not only speeds up the translation process but also maintains high-quality standards. Built-in quality assurance tools, such as terminology checks and linguistic reviews, help identify and rectify errors early on, preventing costly rework later.
Additional Considerations for Life Science TMS
Key considerations for a TMS must include data security, vendor expertise, and scalability, so the chosen system not only meets the current needs but also anticipates future challenges.
Data Security and Privacy
Because data breaches are a constant threat, safeguarding sensitive information, particularly patient data, is critical. Life science companies must adhere to stringent data protection regulations that other industries do not. Regulations set the bar high for privacy and security, requiring strong measures to protect personal data from unauthorized access.
A suitable TMS for the life science industry must offer comprehensive security features that guarantee data integrity and confidentiality.
Vendor Selection
The complexity of life science translations demands a TMS provider with a deep understanding of the industry’s unique requirements. Vendors with proven experience in the life sciences and a track record of successful implementations offer invaluable insights and a level of expertise that can significantly impact the quality of translations.
The right vendor should understand regulations across many different regions.
Scalability and Future Needs
As life science companies expand their global footprint, the volume and complexity of translation needs will inevitably increase.
The ideal TMS should not only handle the current volume of work efficiently but also have the capacity to accommodate future growth without compromising performance. This includes the ability to manage an increasing number of languages, documents, and users, as well as integrating with new technologies and workflows as they emerge.
These considerations make sure that the chosen TMS enhances translation efficiency and accuracy and also aligns with industry regulations, protects sensitive information, and adapts to the evolving needs of the global life science industry.
Selecting the right TMS is a strategic decision that supports the company’s long-term success.
Key Takeaways
A TMS offers significant value by streamlining workflows, enhancing regulatory compliance, and ensuring accurate translations. This, in turn, accelerates time to market for life science products and improves communication across global teams.
For life science companies considering the adoption of a TMS, exploring available solutions is a step toward enhancing their translation processes.
Experience firsthand how XTM Cloud can transform your translation management by requesting a demo today.
Trust XTM Cloud With Your Translations
- Essential TMS Features for Life Science Companies: Life science translations benefit from TMS features such as regulatory compliance, terminology management, and collaboration tools. These features ensure translations meet global standards, consistently use medical terms, and enable efficient project completion.
- Value Proposition of a TMS: A TMS streamlines workflows, ensures accurate translations, and enhances regulatory compliance. This supports faster market access for life science products and improves global team collaboration.
The ideal TMS should not only handle the current volume of work efficiently but also have the capacity to accommodate future growth without compromising performance. This includes the ability to manage an increasing number of languages, documents, and users, as well as integrating with new technolog
Frequently Asked Questions
The biggest challenges life science companies face with translation projects include:
- Ensuring accuracy and consistency across complex medical terminology
- Meeting stringent regulatory compliance standards
- Managing the collaboration between linguists, subject matter experts (SMEs), and internal stakeholders effectively
A TMS is essential for timely regulatory compliance in life science translations. By automating document review and approval workflows, integrating with regulatory databases for up-to-date terminology and standards, and maintaining comprehensive audit trails, a TMS streamlines the translation process. This helps with adherence to regulations like EU-CTR but, crucially, enables organizations to meet tight deadlines, a major challenge in the heavily regulated life sciences industry.
Key features of a TMS for managing medical terminology include customizable glossaries for consistent use of terms, integration with authoritative medical terminology databases, and the ability to enforce terminology standards across all translation projects.
A TMS can facilitate collaboration by providing secure online portals for real-time document sharing and feedback, version control to track changes and maintain consistency, infinite workflow steps (to incorporate as many steps as required, as different projects require different and built-in communication tools that allow for efficient interaction among translators, ICRs (Internal Clinical Reviewers), and SMEs.
A Translation Management System (TMS) ensures data privacy for life science companies in several ways:
- Centralized document management: All documents are stored in a centralized platform, reducing the risk of unauthorized access or data leaks that could occur when using multiple systems.
- Audit trails: TMS keeps detailed records of all changes made to documents, enhancing transparency and ensuring data integrity.
- Secure online portals: Access to sensitive information is limited to authorized personnel through secure online portals, preventing unauthorized access and protecting patient data.
- Version control: Tracking changes made to documents throughout the translation process, providing a clear record of revisions and ensuring accountability.
- Compliance with regulatory standards: TMS is designed to adhere to industry-specific regulations (like HIPAA and GDPR), incorporating features like data encryption and anonymization to protect patient data.
By combining these features, a TMS provides a comprehensive solution for protecting sensitive information in the life science industry.
The benefits of using machine translation in life science translations include increased translation speed, cost efficiency for large volumes of content, and the ability to provide a first draft that human translators can refine, improving overall productivity and turnaround times.
Life science companies can track the quality and efficiency of their translation projects managed by a TMS through features such as performance dashboards, real-time reporting on project status and metrics, quality control checks integrated into the translation workflow, and feedback mechanisms for continuous improvement.
The latest trends in translation technology for the life science industry include:
- the use of artificial intelligence and neural machine translation for improved accuracy
- blockchain for secure and transparent audit trails
- integration of translation technologies with other software systems for seamless information flow across global operations
As with any powerful AI technology, ethical use is important. One concern is ensuring datasets used for training GenAI are diverse and avoid bias, as this can perpetuate harmful stereotypes.
Transparency regarding when GenAI-generated content is used is another consideration. It’s also essential to address the potential impact on jobs in the localization industry and find means to help professionals with reskilling and adapting to changing roles.
Begin by researching reputable GenAI tools and providers specializing in localization. There’s a rapidly growing market, so focus on solutions that align with your most frequent needs. Consider online courses or training programs to gain an in-depth understanding of GenAI capabilities and limitations.
Start by implementing GenAI for small, well-defined projects and gradually integrate it into your workflows as you become more confident using the technology.
About the Author – Iñaki Hernández-Lasa
With over 25 years in the localization industry, Iñaki currently holds the position of Senior Implementation Specialist. During his career, he has specialized in different areas such as Enterprise Terminology Management, Linguistic Technologies, Machine Translation, Linguistic Engineering, and L10N platforms. He currently works on the implementation of language-technology software for enterprise life-science companies. Prior to starting in the localization industry Iñaki completed a research Masters’ degree in Translation Studies. He has been a guest lecturer at Lancaster University and Dublin City University and had different works published in The Irish Yearbook of Applied Linguistics.
