novembro 6, 2020 |
As clinical trials go global, the demand for clinical trial translation services has grown. Companies and researchers in the life science industry need access to accurate data in multiple languages to accelerate innovation.
If you’re planning to run international clinical trials, translation services can help you find the right participants and provide them with all the information they need to give informed consent.
Accurate translation is vital when you work with local experts, so you’ll need to ensure seamless communication between your team members. You’ll also need to translate all the research and its results into the languages spoken in the markets you plan to sell the product developed based on the trial.
It’s a field where miscommunication and confusion can have long-term consequences on hundreds of thousands of customers or patients. A translation error can have public opinion and authorities questioning your ethics and professionalism before you know it. The controversy around your products could damage your reputation and result in significant financial consequences.
In other words, everything needs to be perfect when translating documentation for clinical trials and research reports. With that in mind, here are five clinical trial translation best practices to help you secure clinically sound results.
Translation memory can store all clinical-trial-related terminology and provide the context necessary for translators to deliver excellent content. You can also save translated texts for future reference, which will allow you to speed up translations and cut down costs without sacrificing quality.
One of the advantages of using a translation memory is the increased consistency across translated clinical trials in multiple languages. While it may feel like an extra cost at first, putting together a comprehensive glossary of terms and translation memory is a highly-effective way of achieving translation quality from day one.
Often, bilingual scientists prefer to read clinical trial results in the original language to make sure they don’t miss any crucial detail. That’s because many clinical trial translations lack accuracy or fail to communicate essential research data. A lot can be lost in translation, especially when the original and target languages don’t have many similarities.
If you want to help your target audience, make sure you deliver more than a word-to-word translation of your content. Localization can facilitate the understanding of your documentation, with direct consequences of the results of your research.
Professional linguists doing clinical trial translations must know the target audience well and have the language skills necessary to deliver easy-to-read texts. It’s crucial when you communicate with trial participants, so make sure you localize clinical trial protocols to facilitate understanding.
You should also make sure they know what you’re expecting them to do during the trial, so that they communicate all the information that could influence the outcomes of your research.
Translating clinical trials requires at least a basic level of biomedical knowledge, apart from language skills. It’s hard to find teams of translators who can work fast and deliver high-quality translation simultaneously.
Standards enable linguists to meet quality requirements by following specific protocols. So, look for a language service provider that knows how to follow workflows and is certified to deliver particular translation services. This way, you’ll minimize the risks of misreading or misunderstanding.
Translators need to respect a series of rules when translating regulatorily-approved texts, and standards make this process easier. Overly interpreting the meaning outside the guidelines can easily change the content, and this can have a significant impact on how scientists run the clinical trial or write conclusions.
A language service provider that follows industry standards has trained clinical translators to make sure they can avoid potential liabilities and risks.
Ignoring industry standards to cut down costs could cost you a fortune if you have to redo the entire work. Poor translation could make your research seem incomplete or inconclusive, which can keep your product away from a market unnecessarily.
Entering the market with medicine or medical devices is highly regulated by local laws and international guidelines. When translating clinical trials, your translators should consider all rules and regulations in the local market.
You’re looking at a wide range of rules. If you decide to run a clinical trial outside your home of origin, you need to comply with all informed consent requirements. Make sure local participants receive all the documentation translated and presented in terms they’re comfortable using.
Also, depending on where you want to sell your product, you’ll need to consider local governments and guidelines by organizations like the FDA or international bodies, such as the World Health Organization and the EU Parliament.
As you can see, running international clinical trials implies a lot of paperwork. Most of it needs to be translated not only to increase communication efficiency but also to comply with rules and regulations.
On the one hand, you need to make sure participants are adequately informed about the consequences of being part of the research. On the other hand, you need to make sure that all researchers and specialists receive accurate information and easily interpret it for better results.
In both cases, you’re looking at a complex process in which paperwork and strict protocols take time. Clinical trial translations require Subject Matter Experts. Working with professional translators with a background in this specific niche is vital to deliver 100 percent accuracy in translation.