Clinical trials address the research problems that have to be carried out by attesting the different drugs and medicines on humans and animals. This practice allows the researchers to evaluate and analyze the effects of the new medicines. Clinical trials have become an integral practice for medical and pharmaceutical companies as a part of the process of launching new medical products, after their discovery, and development. Clinical trial translation has become significant given the fact that most clinical trials are carried out in different countries for many reasons. The whole process is a complex, hectic, and lengthy process. And translating the content includes a plethora of medical documents as part of this process. The quality of the data, text, and calculations depends on the translation.
The translation has intervened in every medical process now. It has started playing the role of the main facilitator between different people speaking different languages.
They come from different regions and countries to collaborate for research and share their findings without thinking about the language barrier. However, the process of clinical trials and medical document translation is quite complex and draining. It is extremely vital that translators and translation services take care of unforeseen challenges. They should ensure they hire experienced, subject matter experts for the translation of clinical trials and medical documents.
Therefore, it is also important that they consider certain aspects while working on clinical trial translation services.
Quality assurance
Quality is the main ingredient of a translation. When it comes to medical content and medical document translation services, it gets more vital to not promise quality. During the process of clinical trials, translation is especially of main focus due to the fact that this process involves a lot of people, relying on the participants and volunteers mainly. Also, the teams start the process of clinical trials after going through a lot of effort and getting approval on a number of documents. Hence, minor negligence or below-average-quality translated content can put them behind for many reasons. Therefore, a proper quality assurance process should be carried out to analyze the quality and content.
A standard list of glossaries
This should be the top aspect to consider for the translators as well as the team of researchers and scientists who are working on the translation. The medical field is full of challenging and complex terms that also come in the way of the flow of translation. Many medical terms don’t have the right translation or correspondence in the target language during the translation process. Such scenarios make it hard for the translators to maintain the quality and original intent of the translation. In order to cater to such issues it is better to work on a list of glossaries that have all the important terms and phrases (with a brief definition) that are going to be used frequently in the translation process. Its simple translation can help translators maintain consistency and quality in the context of clinical trials.
Compliance with regulatory authorities
Professional medical translation services need to have compliance with the regulations and legal matters. This is the basic difference between general and other translation processes. The medical practices have differences with the regions. Particularly, while conducting clinical trials the makers and owners have to consider a number of factors. They need to take the clearance beforehand even before starting their process. They need to submit copies in the relevant official language and also have to take undertakings for many factors. Therefore, legal analysts and experts as well as medical translators with experience in translation in a legal context have to take care of the translation services. The medical and clinical trial text contains sensitive information that can be the reason for people’s life and death and hence it needs to be monitored legally too to mitigate the risk of mistakes.
The trial and research companies need to conform to the following legal bodies for smooth operations.
- World health organization
- European Union
- Food and Drug Administration
- Relevant countries’ national regulations
These bodies ensure that translation is accurate and there are no errors and mistakes and translations are good to go.
Back translation
There are many regulatory authorities that ask for back translation as a process of clinical trials and certified medical translation services. Back translation helps people identify the errors and ensure that the original document is also safe and error-free to proceed with. The translators are often asked for the back translation to guarantee that the translated content is accurate and represents the exact meanings of the translations. This is also practiced as part of the quality assurance process. However, it is important that the people performing it understand the process of back translation. Moreover, it is also worth mentioning that these do not come as same as the original document. Hence, it requires validation from the relevant linguists and authorities.
Cultural considerations
Considering cultural factors and appropriateness is an important practice of translation in general. Taking cultural practices into account gets significant for clinical trials and medical translations. The participants and volunteers who are participating in the clinical trials will never agree to do so if they find the things violating their cultural values. Therefore, cultural knowledge is a prerequisite to an acknowledged and quality clinical trial translation. A number of medical diseases, practices, and problems are social taboos in many countries and are not openly being discussed as in other countries. Therefore, the teams and the developers have to be vigilant on this part and need to carry out the process as per the cultural requirements.
Conclusion
Clinical trials are evident for the medical and pharmaceutical industries to bloom and rise. These are often carried out in different countries and the owners have to consider multiple factors while outsourcing the clinical trial translation services. They need to take care of regulatory insight, and back translation as well as cultural consideration among others.
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