Working with people and not relying on inflexible systems is crucial
The quality systems that we work to, such as GMP or GCP, provide control in our work that directly improves the lives of many people, within which, patients’ safety is fundamental. However, with clinical trials increasingly run on an international basis, involving many different territories simultaneously, how do clinical trial administrators ensure the quality of the translations that they are responsible for without the specific knowledge of the target languages? In other words, when working ‘blind’.
Crucially, it is about working with people and not relying on an inflexible automated workflow system.
With most translations being outsourced, the quality of the work can vary massively, often resulting in poor translations having to be corrected in-house, leading to additional costs and delays for the pharmaceutical company or CRO. If you therefore choose to work with a Language Service Provider (LSP) to manage this process, it is important to know exactly what is involved to ensure your translations are right first time.
Firstly, the ISO-recognised process comprises translation and then revision by a second independent linguist, with any disputed translations resolved by the LSP. Further optional steps include a second revision, in-country client review, and back translation, although the latter can double your costs without necessarily improving the quality of the original translation. There is also often the need for a review by an Ethics Committee (EC), which can remove some errors, but can introduce spelling or grammar errors too. Any EC or client changes should be sent back to the original translators to be checked again.
Further quality can be built into the process by using qualified translators with relevant medical expertise and using skilled linguists as project managers. Consistency can be improved by using the same translator for the whole project, although depending on the size of the documentation,this may sometimes be hard to implement, and translation memories will also help here (saving time and money too).
Finally, with complex project soften including 500–750 different documents, there should be a strong version control and tracked changes within the workflow system.