How Tomedes Resolved Client's Compliance Challenges by Translating Regulatory Documents in Clinical Trials

Our client

Company Name: Smerud Medical Research UK Ltd 

What does the company do? 

Smerud Medical Research UK Ltd is a clinical research organization specializing in regulatory compliance and clinical trial documentation.

What do they need? 

The client required an accurate Spanish (Spain) to English translation of medical and legal regulatory documents to ensure compliance with clinical research and legal standards. The translation needed to reflect precise medical terminology, research protocols, and legal language while maintaining the integrity of the original content. These documents were essential for regulatory submissions and legal assessments, requiring absolute accuracy in both language and industry-specific terminology.

The challenges

The Tomedes team excels in translating regulatory documents with precision, ensuring compliance with medical and legal standards. However, even with our deep expertise, this project presented unique challenges. Here are some of the issues we encountered: 

Firstly, translating clinical research documents demands absolute precision to ensure medical terms, research protocols, and legal language remain accurate. Any errors could cause miscommunication, regulatory issues, or legal disputes. This project required maintaining industry-standard terminology while preserving the legal integrity of the confidentiality agreement and clinical research report.

Secondly, clinical trial regulatory documents must meet strict health authority and legal requirements to ensure accuracy and compliance. The translation needed to be clear, consistent, and legally valid for regulatory submissions. Any errors could lead to delays, rejections, or legal issues for the client.

Lastly, clinical trial reports include complex scientific data, regulatory approvals, and legal agreements, requiring expertise in both medical research and legal documentation. The translator needed strong linguistic and industry knowledge to ensure clarity and accuracy. Careful formatting and review were essential to maintain the report’s original intent, coherence, and professionalism.

Why Tomedes?

Tomedes is a trusted translation company in medical and legal translations, providing precise, compliant, and industry-specific translations for clinical research and legal documents. Our expert linguists have specialized knowledge in medical terminology, research protocols, and legal frameworks, ensuring clarity, accuracy, and regulatory adherence. With a proven track record in clinical trial documentation, we delivered a translation that met stringent industry standards, giving the client confidence in their regulatory submissions.

Beyond linguistic accuracy, Tomedes is recognized for delivering high-quality, regulatory-compliant translations tailored to medical and legal requirements. Our rigorous quality assurance process eliminates risks of legal or compliance issues, ensuring the integrity of every document. While the client had no strict deadline, we provided a fast, seamless, and high-precision translation, allowing our clients to move forward with confidence. Our commitment to excellence, compliance, and efficiency made us the ideal partner for this critical project.

The solution

To ensure the accuracy and compliance of the translated documents, Tomedes implemented a meticulous approach tailored to the complexities of medical and legal content. Here are some of the key strategies we used to guarantee a precise and regulation-compliant translation:

Firstly, to ensure accuracy and compliance, Tomedes assigned expert translators with medical and legal backgrounds. With experience in regulatory affairs, clinical trials, and legal contracts, they accurately translated complex terminology and legal phrasing. This ensured the final documents retained their scientific integrity and legal validity.

Secondly, we used industry-specific terminology management to ensure consistency and accuracy in the translation. By leveraging a regulated terminology database, we aligned with medical and legal standards, eliminating ambiguities and preserving legal precision. This ensured the translation met regulatory and legal requirements with clarity.

Lastly, to ensure top quality, Tomedes used a multi-step review process with linguistic validation, compliance checks, and final proofreading. Senior medical and legal translators conducted peer reviews to meet industry standards and client needs. This rigorous quality control ensured a flawless, reliable, and compliant translation.

The result

Tomedes delivered a flawless medical and legal translation, ensuring that the client’s clinical research and legal documents met the highest industry standards. Every term, phrase, and section was translated with precision and clarity, maintaining the integrity of the original content. With our specialized expertise, the final translation was accurate, well-structured, and ready for immediate use.

The translated documents were fully compliant with regulatory requirements, requiring no additional modifications for submission. This seamless process allowed the client to proceed with their legal and research obligations without delays or concerns. As a result, Smerud Medical Research UK Ltd was highly satisfied with Tomedes’ accuracy, professionalism, and efficiency, reinforcing our reputation as a trusted partner for specialized translations.

Conclusion

For highly regulated industries such as medical research and legal documentation, precise and compliant translations are crucial. Tomedes ensures expert medical and legal translations that align with industry regulations.

Ensure accuracy and compliance with expert medical and legal translations from Tomedes. Our specialized linguists deliver precise, industry-specific translations tailored to regulatory standards. Contact Tomedes today to guarantee seamless, high-quality translations for your critical documents!