The Need for Subject Matter Experts in Clinical Trial Translation

The term “technical translation” refers to the translation of documents targeting specialist audiences instead of the general public. The specialized nature of technical translation highlights the importance of having subject matter experts (SMEs) involved in the translation process. This is particularly true in highly specialized fields such as clinical trials, where accuracy and precision can be a matter of life and death.

The Critical Role of Subject Matter Experts

Subject matter experts, with their deep understanding of the intricacies of clinical trials, play a pivotal role in the translation process. Their expertise not only ensures linguistic accuracy but also guarantees contextual appropriateness and scientific precision. Here are key reasons why SMEs are indispensable:

Terminological Accuracy

Clinical trial documents are replete with technical terms specific to medical and pharmaceutical fields. SMEs have the requisite knowledge to accurately translate these terms, ensuring consistency and clarity.

Regulatory Compliance 

Given the specific regulations and guidelines for clinical trials in different countries, SMEs are a crucial asset. Their familiarity with these regulatory requirements ensures that translated documents meet all necessary legal and compliance standards, providing you with the confidence of regulatory compliance. 

Cultural Sensitivity

Cultural sensitivity is critical for participant comprehension and engagement in clinical trials. Working with SMEs can ensure that the translation is culturally appropriate and that the trial participants feel understood, respected, and valued.

Precision in Data Translation

The data collected during clinical trials must be translated with extreme precision to ensure that the results are reliable and valid across different languages. For instance, a mistranslation of a side effect could lead to incorrect safety assessments. SMEs have the expertise to handle complex data translation accurately.

Consistency in Multi-Language Trials

In multi-language clinical trials, ensuring consistent terminology across all translated documents is crucial. While SMEs focus on maintaining consistency within their respective language translations, overall consistency across multiple languages is primarily overseen by the Project Management/Quality Assurance team. This team plays a critical role in making sure that terminology remains accurate and uniform across all languages involved in the project, allowing for effective data comparison and analysis.

Translation Support from DTS Language Services

DTS Language Services understands the importance of accurate clinical trial translations. Our team of experts follows a reliable process, which includes thorough review and verification by SMEs, to manage these translations effectively. We assist you in meeting regulatory deadlines and ensuring the successful launch of your drug or device.

We know that obtaining premarket approval (PMA) for Class III, and sometimes Class II, pharmaceuticals and medical devices requires thorough clinical trials and reviews. With over five decades of experience working with Clinical Research Organizations (CROs), sponsors, pharmaceutical companies, and medical device manufacturers, we understand the complexities involved.

DTS Language Services plays a crucial role in translating trial documentation for Institutional Review Boards (IRBs), the Food and Drug Administration (FDA), and international agencies like the China Food and Drug Administration (CFDA). Our expertise helps ensure your documentation meets all regulatory requirements, and we work closely with you to address any specific translation needs or concerns.