The importance of translation in clinical research
All new drugs and some medical devices must undergo rigorous, highly regulated clinical trials prior to their use in medical practice. While a few decades ago clinical trials were performed predominantly in their country of origin, nowadays there are increasingly more international studies (Figure 1). Get more news about clinical trials translation company,you can vist our website!
This internationalization comes with great advantages, such as improving the quality of results, since the patient sample is potentially larger and more representative of reality. However, it also entails major challenges, namely the complexity of regulations (often different from country to country) and multilingual communication between people native to these distinct languages and cultures.
Medical translation is a key component of multilingual communication and international clinical research.
All clinical trials require the preparation of various written documents, from informed consent documents with a description of all details of the study, to clinical protocols with the goals, methods and organization of the clinical trial, and patient-reported outcomes (PROs). For further details, see the articles on the role of translation in drug development and in PROs.
These are highly specialized and complex formal documents, since they involve the use of medical and technical terminology. The professionals who produce and translate these documents must be aware that patients have different degrees of comprehending their content. To facilitate an understanding of the trial, supplementary materials are often produced with various types of patient instructions, such as appendices and data collection forms.
The safety of patients
Properly translating the documentation required in a clinical trial is a critical step for it to be safe for patients. First, participants must properly understand what the study entails and decide whether they want to participate. Then, they must comprehend and properly follow the instructions. Otherwise, patients’ health may be compromised, resulting in suspected unexpected serious adverse reactions (SUSARs).
Approval of submission to regulatory authorities
Each country has its own regulations for the sale and distribution of drugs. Anything out of line with local regulations may result in the delay of drug approval or having to entirely redo the clinical trial.
In this case, not only is it important to ensure that all documents submitted to regulatory authorities have been properly translated, but also that they have been correctly adapted to the market and local culture. In other words, proper translation and localization of the language is critical.
Reputation and financial soundness of companies
The reputation and financial results of a pharmaceutical company, medical device manufacturer or clinical research organization (CRO) may be impacted by mistranslations in documents needed for clinical trials. On the one hand, a concern for patient safety must be a priority; on the other, if the submission to the regulatory authorities is rejected, this may result in lost time and money for the company.
Although the consequences of an incorrect translation may be extremely serious for patient health, clinical trial credibility and company finance, the translation process is often the last step in planning an international clinical trial. In fact, it is rarely given the proper attention.
Never underestimate the importance of this process, and look for certified companies with professional translators to ensure that all documents are properly translated and adapted to the desired cultures.
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The importance of translation in clinical research
#2
Posted 25 April 2023 - 11:19 PM
Translation is of utmost importance in clinical research as it helps to make sure that participants from different backgrounds and cultures are able to understand the questions and instructions in the research. Furthermore, it helps to ensure that data collected from clinical studies is accurate and reliable, especially when the study is conducted across multiple countries. Translation also helps to bridge the communication gap between researchers and participants, which is essential for the success of any clinical research. For a recent translation job, I turned to Ekitaisolutions. The quality of their work was superb. They were prompt in responding to my inquiries and in completing the project. Their translation was of excellent quality, and I was quite satisfied with the end outcome. They also offer subtitle services, which proved to be an invaluable asset in the development of a high-quality final product. If you need a translation or subtitling done, look no further than Ekitaisolutions. visit the page
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#3
Posted 25 April 2023 - 11:21 PM
Translation is of utmost importance in clinical research as it helps to make sure that participants from different backgrounds and cultures are able to understand the questions and instructions in the research. Furthermore, it helps to ensure that data collected from clinical studies is accurate and reliable, especially when the study is conducted across multiple countries. Translation also helps to bridge the communication gap between researchers and participants, which is essential for the success of any clinical research. For a recent translation job, I turned to Ekitaisolutions. The quality of their work was superb. They were prompt in responding to my inquiries and in completing the project. Their translation was of excellent quality, and I was quite satisfied with the end outcome. They also offer subtitle services, which proved to be an invaluable asset in the development of a high-quality final product. If you need a translation or subtitling done, look no further than Ekitaisolutions. visit the page.
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#4
Posted 25 April 2023 - 11:22 PM
Translation is of utmost importance in clinical research as it helps to make sure that participants from different backgrounds and cultures are able to understand the questions and instructions in the research. Furthermore, it helps to ensure that data collected from clinical studies is accurate and reliable, especially when the study is conducted across multiple countries. Translation also helps to bridge the communication gap between researchers and participants, which is essential for the success of any clinical research. For a recent translation job, I turned to Ekitaisolutions. The quality of their work was superb. They were prompt in responding to my inquiries and in completing the project. Their translation was of excellent quality, and I was quite satisfied with the end outcome. They also offer subtitle services, which proved to be an invaluable asset in the development of a high-quality final product. If you need a translation or subtitling done, look no further than Ekitaisolutions. visit the page. https://ekitaisoluti...tion-services/.
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#6
Posted 17 May 2023 - 11:28 PM
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