Clinical Research and Trials Translations

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A Story of Success

Complex Translation Project: Informed consent forms for 6 countries in 3 continents

Learn how we helped a biotech company successfully conduct a clinical trial on 3 continents.

Our client: A biotech company based in United States

Language pairs: English into 6 languages

Description: Our client was conducting a clinical in 6 countries, with the goal of answering specific questions about a new treatment

Key people: Clinical trial managers and ethics committees

Type of documents: Informed consent forms

Volume: 30 pages in Word format, with 3 types of informed consent forms

Delivery time: 14 business days

Target audience: Study participants

Key challenges:

• Producing a quality translation while making sure the target audience in each country could understand the information and act appropriately
• Harmonising the texts to achieve semantic and conceptual equivalence across all translations in all languages
• Complying with the local template for informed consent forms where applicable
• Absolute secrecy and total confidentiality restrictions requiring cyber-security measures

Solution:

Solution:

We began with an analysis of the source text before starting the translation in order to identify sections featuring any translation problems. During this analysis, we looked out for any pragmatic, linguistic, cultural and text-specific challenges.

For this client, we prepared two forward translations for each of the languages. We then merged these together to create a final version of the forward translation.

In order to avoid any ambiguities, we performed a back translation of the final forward translation and compared this with the original. This allowed the translation team to identify and analyse any differences between the original and the reconciled translation. We then reviewed the translations to resolve any issues.

The next step was possibly the most important; harmonisation. The translation team compared the back translations of all 6 language versions with each other, and with the original document. This way, we could make sure we achieved semantic and conceptual equivalence across all the translations.

The final step was to proofread all the translations. During this final review process, we identified and corrected any typographic, grammatical or other errors.

Happy ending: 

The informed consent forms were quickly approved by the ethics committees without any issues, and the clinical trial was carried out successfully.