Sharing Experiences at the Clinical Trials for Medical Devices Congress
September 06, 2016Nadège Young
On September 21-22, Argos Multilingual will be attending the 2nd International Congress on Clinical Trials for Medical Devices (CTMD2016). We are glad to be part of this conference, where our COO, Nadège Young will be sharing her experiences on implementing quality methodology into clinical trial translation programs.
To give you a sample of what you can expect, we talked to Nadège about her upcoming presentation on the topic of “How the use of technology and pre-defined quality methodology can help remove subjectivity and ambiguity from the translation process”.
In your presentation, you will talk about the benefits of using technology and quality methodology in the translation process – what is so special about it especially in the case of clinical trial content?
Nadège: The benefits of using technology and a defined quality methodology are related to time, efficiencies and quality. From the quality of the source content to the automated checks performed on the translation. It is key that the source content is clear and ready to be processed through the translation process. Quality at source methodology can validate the content and automated Quality checks will ensure the output is free of errors. This is critical when it comes to Clinical Trials documents as errors in translation could have damaging consequences for trial participants and the company itself. Technology at the translation management level on the LSP side is also crucial as so many resources have input in the translation.
In your experience, what is the most challenging part when translating clinical trial content?
Nadège: Clinical trials content varies greatly, from technically complex protocols to informed patient consent forms. Translation is a complex process and there should be no room for interpretation. An inaccurate translation could have serious consequences in terms of human life and damage to the company.
One of the challenges is pairing the resources to the content types. In a perfect world, a biomedical translator who can translate a document type beautifully should do so with other documents in the same sector. This is not the case and several resources are needed for different document and content types.
Another challenge, like in many other sectors, is that the translation is often not planned into the whole lifecycle of the trial and decided mid-stream. The challenge is for the localization supplier as the content may not be applicable or appropriate for the local audiences, especially from a cultural aspect. There is a need for globalization and localization at the content creation stage that often time does not happen and causes the translation supplier to have many questions to the client which may lead to quality issues and will definitely lead to delays.
What advice can you provide life sciences companies to overcome this challenge?
Nadège: Companies should use a controlled English approach and validate the source content for translatability. A key element of this being: one word, one meaning.
Another advice is to make sure the content is localized to the target audiences and specifically to the participants of the trial, especially when it comes to dosages or side effects.
What would you like the audience to gain thanks to your presentation?
Nadège: I hope that the presentation will bring awareness of the complexity of the translation process and what technology and quality solutions the translation supplier should apply to make sure the documents are accurate and appropriate.