Compliance-Ready Pharmaceutical Translation Delivered by Tomedes

Our client

Company Name: Université Médicale de Lyon (Pseudonym)

Industry: Medical and Pharmaceutical Research

What Does the Company Do? 

A premier French medical university engaged in cutting-edge clinical research and healthcare innovation.

Deadline Set by the Client: 2 days

What Did They Need?
Université Médicale de Lyon required a certified Japanese-to-French translation of confidential documentation for a clinical research project (PHRC-I). The documents, originally in Japanese, contained highly technical details about an experimental drug, necessitating precise translation to ensure accuracy in pharmaceutical terminology and regulatory compliance. Given the sensitivity of the content, strict confidentiality measures were also essential to protect the integrity of the research.

The challenges

With years of experience providing certified translations for regulatory and compliance purposes, the Tomedes team is well-versed in handling highly technical medical and pharmaceutical documents. However, despite our expertise, this project presented unique challenges:

Firstly, the translation of pharmaceutical research documents presents a unique challenge due to the complexity of medical terminology. The documents contained highly specialized language, including pharmacological data, clinical trial protocols, and drug formulations. Accuracy in translating such terms is crucial, as even a minor misinterpretation could lead to scientific miscommunication, regulatory non-compliance, or potential risks to patient safety. To ensure precision, a translator with expertise in medical and pharmaceutical sciences was necessary to handle the project.

Secondly, since the documents involved an experimental drug in clinical research, strict confidentiality measures were required. The hospital mandated a non-disclosure agreement (NDA) to protect sensitive information. The translation also had to follow clinical research regulations, GCP guidelines, and international standards, as any errors could compromise the study’s credibility and approval.

Lastly, the hospital needed the translated documents to be officially certified for submission to regulatory bodies and research institutions. Certification ensured the translation was accurate, verified, and legally valid for formal use. This required expert linguists and strict certification standards to meet the approval of ethics committees, regulators, and scientific reviewers without delays.

Why Tomedes?

Tomedes is a trusted translation company with extensive experience in pharmaceutical and medical translation, ensuring accuracy in highly specialized fields. Our expert linguists possess deep knowledge of clinical research, pharmacology, and regulatory requirements, allowing us to deliver precise translations for technical documentation and clinical trial reports. With over 17 years of experience, we have successfully partnered with hospitals, research institutions, and pharmaceutical companies to support medical advancements with industry-specific, contextually accurate translations.

Beyond expertise, Tomedes prioritizes strict confidentiality and compliance, understanding the sensitive nature of medical documents. We provide non-disclosure agreements (NDAs) before handling any client material and ensure all translations meet regulatory and legal requirements for official use. To guarantee quality, our certified translations come with a 1-year accuracy guarantee, giving clients confidence in the precision and integrity of their documents.

The solution

To deliver a precise and compliant pharmaceutical research translation, Tomedes implemented a strategic, multi-step approach. In this section, we will discuss how our team ensured accurate and compliant translations:

Firstly, to ensure accuracy and precision, Tomedes assigned native French translators with expertise in medical and pharmaceutical research. These professionals understand clinical trial documents, regulatory language, and pharmaceutical terms, ensuring a clear and compliant translation from Japanese. Given the complexity, only experienced medical translators handled this critical task.

Secondly, before translation began, Tomedes used its AI-powered Pre-Translation Toolkit to improve accuracy. This tool identified key terms, flagged inconsistencies, and assessed text complexity, ensuring the best translation approach. By addressing challenges early, we streamlined the process and reduced errors for a precise and contextually accurate translation.

As presented in this free sample, its Key Terms Glossary has played a crucial role in preparing the source text by ensuring that essential medical terms are accurately defined and translated. By standardizing terms such as "médicaments prescrits" (prescribed medications) and "effets secondaires" (side effects), it minimizes ambiguity and ensures consistency across the document. This preparation helps streamline the translation process, reducing errors and ensuring that medical information remains clear, precise, and easily understood in different languages.

Finally, the translation underwent rigorous quality checks to ensure certification and compliance. A second medical research linguist reviewed it for accuracy, consistency, and regulatory alignment. The final certified translation met all legal and industry standards for clinical research approval.

The result

The client was highly satisfied with the certified, error-free translation, which was carefully reviewed for accuracy and clarity. They appreciated how Tomedes ensured that all medical terms and regulatory details were correctly translated, eliminating any risk of misinterpretation. This gave them confidence in submitting their clinical research documents for official use, knowing the translation met the highest standards.

Beyond accuracy, the client valued our commitment to confidentiality and compliance, especially with PHRC-I regulatory and ethical standards. The strict security measures and NDA agreement reassured them that their sensitive research was protected at every stage. Impressed by the professionalism and reliability of the service, the client expressed interest in partnering with Tomedes for future medical translation projects.

Conclusion

Université Médicale de Lyon successfully obtained certified and confidential translations of their pharmaceutical research documents, ensuring compliance with industry standards. 

With expertise in medical and pharmaceutical translation, Tomedes is the trusted partner for accurate, secure, and regulatory-compliant translations. Need a reliable certified medical translation? Contact Tomedes today!