In today’s globalized world, introducing new medical devices and drugs to the global market requires careful localization. The importance of localization, particularly in life science translation, cannot be overstated. From patient recruitment to trial completion and the acceptability of Patient Reported Outcomes (PRO) instruments across languages and cultures, ensuring life science content is available and understandable in patients’ native languages is crucial. This not only builds trust but also improves patient engagement. Therefore, life science translation must undergo the most rigorous process to meet localization and global regulatory compliance needs.
In this post, we will explore five tips for achieving success in life science translation.
1. Communicate in the Patients’ Language
Understanding complex medical information could be challenging. Whether translating clinical trial content or medical labeling, the risk and liability associated with could result in delays in your pipeline or product recalls. Medical translation errors in labeling or instructions are a leading cause of medical device recalls. In the context of clinical trial content, using simple, understandable, and non-idiomatic language is extremely important. For example, Europe passed a regulation EU No 536/2014. The PLS enables people to understand complex clinical information without medical terminology, thereby reaching a more diverse patient population and expediting the process of bringing new medicines to market.
Clinical content for translation:
● Case Report Forms（CRF)
● Clinical Outcome Assessments (eCOA/COA)
● Ethics Correspondence
● Patient Questionnaires
● Medical Safety Reports
● Patient-Reported Outcomes（PROs）
Three types of labels:
● Labels affixed to the internal containers of products, such as being part of the medical device.
● Labeling information on product packaging (outer cardboard boxes, product boxes, product bags).
● Patient information leaflets (PILs) printed on paper, usually included with the product packaging.
2. Develop a Terminology Glossary
Consistency in terminology is crucial in life science translation. Before beginning a localization project, create a glossary that includes names of devices, branding terms, and technical terms specific to your company and product. Sharing this glossary with your language service partner ensures consistency and accuracy across all document versions, saving time and reducing the risk of errors during the localization process.
3. Adhere to Regulatory Guidelines
Life science translation often involves regulatory affairs, such as NDA and BLA. Companies need to ensure these translations meet strict standards and comply with regulatory guidelines. Accuracy is critical when translating content related to drug development, clinical trials, and regulatory compliance. On April 15, 2024, the regulation MDCG 2024-4 is endorsed by the Medical Device Coordination Group (MDCG). There are some important points to note regarding safety reports for performance studies:
● Any serious adverse event that has a causal relationship with the device, the comparator, or the study procedure or where such causal relationship is reasonably possible;
● Any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate;
● Reporting any new findings related to the events mentioned above.
By adhering to these reporting requirements outlined in MDCG2024-4, manufacturers can ensure transparency and compliance with regulatory standards, thereby enhancing product safety and efficacy in the European market.
4. Use Icons Appropriately in Texts
Images can often convey messages more effectively than text alone. Many manufacturers use videos or animations to complement traditional instruction manuals. Utilizing internationally recognized medical symbols, such as those for Medical Records, Emergency, and Antenatal Care Units, can enhance communication in medical communities.
5. Choose ISO Certified Translation Services
When selecting a professional localization company, ensure they provide qualified subject matter experts (SMEs) and adhere to ISO 9001, ISO 13485, and ISO 17100 standards. These standards offer relevant guidance across various translation services, confirming that the language service provider (LSP) has a specific emphasis on life science translation and maintains a stringent linguistic review process.
EC Innovations – A Trusted Localization Partner
EC Innovations is your trusted partner for technology-driven product localization solutions. With over 20 years of industrial experience, we have assisted leading multinational companies across various industries. Our life science translation services help companies overcome language barriers in international business and meet all regulation requirements. With the ability to translate complex content into over 140 languages, we can address the full scale of your translation needs. Interested in learning more about Life Science Translation? Contact us today, and we will be happy to support you.