Beyond the standard workflow that we apply to most translation projects (if there are no special specifications from the client), we can adjust our work methods and processes to meet the client’s more demanding requirements, conceiving and applying a custom translation workflow. The regular workflow (translation + revision/editing + proofreading, or “TEP”) will normally involve the project manager and at least two distinct linguists (for the translation and revision stages). However, when a client needs additional quality assurance (QA) measures, this standard workflow needs to be replaced by much more complex ones.
The life sciences sector is, reputedly, one of the most demanding industries in terms of regulatory compliance. Drugs and medical devices manufacturers require extra steps to make sure that the final translation is accurate and consistent, that there are no omissions and that the end beneficiaries of the target language text imply the same meaning as the readers of the original text. For illustration purposes, we have thought it useful to provide a relevant case study, illustrating the complexity of a translation project in the medical field.
Scope of project:
A software application dedicated to patient examination needs to be localized, as part of a clinical trial conducted for a psychiatric medicinal product.
It is not very large, only about 19.000 source words, but the language of the questionnaire is particularly complex and includes a large number of subtle distinctions and nuances.
English to Romanian
The client needs to make sure that Romanian patients enrolled in the trial respond to the prompts and questions in the software in exactly the same manner as patients who are native English speakers would respond to the original questionnaire. For this, the client wants to use translation followed by back-translation, followed by a review of the back-translation and feedback given to the team of linguists.
- Translation A = translation of source text into Romanian by translator 1 (T1)
- Translation B = translation of the same source text into Romanian by translator 2 (T2)
- Revision and harmonisation = bilingual revision and harmonisation of versions A and B by a reviser (R1), resulting in a single, “harmonised” translation (TH)
- The Romanian translation produced in stage (3) is re-translated into English (back-translation) by a native speaker (T3)
- The English source text and the English back-translation are compared by a native speaker expert in the field (the end beneficiary’s representative); the goal is to preserve the fundamental meaning of the original, while making annotations where there is reason to believe that the meaning has been altered or lost between the original and the back-translation (R2).
- The feedback from R2 is forwarded to the Romanian reviser and the TH version is adjusted accordingly. This becomes the final version.
Our team (project manager, two EN-RO translators, one RO-EN translator, one RO reviser) covered all project stages, except the fourth one, which was completed in-house by the end beneficiary.
While such a custom translation workflow will obviously generate additional costs and will push forward the deadline of the entire project, it comes to prove that quality comes at a price and that the outcome of such an endeavour will depend on the flexibility of the project team and their ability to communicate effectively and constructively.