With the resurgence of dangerous diseases such as whooping cough, malaria, and cholera, the need for clinical trials spanning the globe is stronger than ever.
Diseases affect people differently depending on factors such as environment, climate, and ethnicity. This augments the need for a diversified population to undergo clinical trials—but ensuring a representative global population for clinical trials can be time-consuming and expensive due to differences in location, culture, and language.
By centralizing your translation and localization services for a global audience, it is possible to reduce the time, money, and effort needed to effectively complete a clinical trial and make progress toward eradicating disease.
Here are some of the ways centralizing the clinical trial process with a single Language Service Provider (LSP) can help Contract Research Organizations (CROs) and pharmaceutical companies save time and money.
Consistent Language Expertise
Although most clinical trials in the past have taken place in the United States and Western Europe, clinical trials outside of the U.S. have doubled in the last 10 years. Emerging markets in Asia, including developing countries like China and Vietnam, as well as developed countries like South Korea and Singapore, are particularly attractive sites for clinical trials because of their growth potential and demand for new medicines and treatments.
However, expanding from a U.S. market to a global market requires extensive knowledge of local languages in order to conduct these trials, aid in recruiting volunteers, navigate the regulation landscape, and ensure that all participants can give informed consent to take part in the clinical trial.
Poorly translated or poorly localized documents that are subsequently rejected by local authorities/ethics committees can have a major impact on study start-up timelines and overall cost.
An experienced LSP will be able to provide accurate translation services for a variety of languages, and will be able to effectively coordinate efforts across countries and languages even while tailoring materials to each specific country.
Administrative Uniformity
Working with the same LSP to translate documents such as investigator brochures, clinical trial protocols, Clinical Trial Agreements (CTAs), Informed Consent Forms (ICFs) and Patient Reported Outcomes (PROs), can reduce administrative burden and communication issues for the research team.
Specifically, centralizing the translation process with one LSP streamlines the workflow by offering consolidated reporting, reducing time spent in meetings, and cutting down on repetitive translations.
With one LSP, CROs and pharmaceutical companies can create Translation Memories, which define clear terminology to be used across clinical trial projects. During the translation process, a Translation Memory will scan a new document and automatically translate a word or phrase to match the definition found in the standardized translation memory, thus saving time for human translators and saving money for the client.
Overall, the more work an LSP does for a client, the more experience the LSP acquires and the easier it is to process new information, including knowledge, vocabulary, and style.
A Trustful, Ongoing Partnership
Taken together, Annex I and UDI impose significant new requirements on all stakeholders in the supply chain for medical devices, from manufacturers down to healthcare professionals. Here are some tips to help bring positive change in the quality of patient experiences and ease your organization’s transition to the new requirements.
Languages
With so many languages spoken in the EU, labels are often expected to be multilingual. However, UDI formatting requirements make external labeling space smaller, making it harder to include multiple languages or use languages that take up more space. Working with a language solutions partner can help your organization optimize the limited space to fulfill or exceed all requirements and best serve the consumer.
Data Management
Data security becomes of increased importance to any stakeholders who interact with the data from medical devices. These stakeholders, who may include manufacturers, distributors, and healthcare institutions, must update their quality management systems to ensure data is properly and securely stored.
Content Management
Managing label changes for multiple devices can be expensive and time-consuming. Having a clear understanding of the labeling requirements beforehand – including what technology is needed to streamline the process and what information will need to be updated most often – will help your organization prioritize resources and implement a content management system that includes a revision strategy for electronic labeling.
For more information on changes to Annex I and UDI requirements, check out ULG’s webinar on the topic.
