Tomedes Refines Clinical Trial Documents for Multi-Age Audiences in 3 Days

Our client

Company name: Rainbow MedTrial Solutions, Ltd. (Pseudonym)

What does the company do?
A specialized provider of clinical trial management and regulatory support services for international pharmaceutical studies.

Deadline set by the client: 3 days

What do they need?
The client required a meticulous revision of five clinical documents translated from English to Spanish. These included patient-facing materials tailored to different age groups, necessitating precise tone adaptation and medical accuracy. The client aimed to ensure linguistic consistency, appropriate terminology, and structural alignment with previously approved documents from another study arm.

The challenges

When revising clinical trial documents, precision extends beyond terminology—it also encompasses tone, structure, and consistency. For this project, Tomedes was tasked with addressing several complex linguistic and technical challenges to ensure the translations met both professional and patient-centered standards. Here are some of the challenges the team encountered:

First, one of the primary challenges involved adapting the tone of the translations to suit the intended audience. This required the use of informal language (“tú”) for documents directed at children and adolescents, while maintaining a formal register (“usted”) for content aimed at parents. The nuanced handling of these variations was crucial to ensuring both comprehension and appropriateness, particularly in sensitive medical contexts.

Second, the documents contained numerous medical and oncology-specific terms that needed to be consistently applied across all materials. Given that the original translations were produced by different professionals, discrepancies in terminology were a risk. Tomedes was tasked with harmonizing the language to meet clinical accuracy standards and ensure coherence for all patient-facing materials.

The project included documents from two separate arms of a clinical study. While structurally similar, these texts required careful alignment to ensure that all phrasing, terminology, and stylistic choices matched those of the already finalized reference materials from Arm I. This was especially important for preserving the integrity of the study’s documentation and ensuring regulatory compliance.

Why Tomedes?

Tomedes is an international translation company that specializes in translating complex medical documents, including clinical trial documentation, informed consent forms, and patient communication materials. Tomedes team has specialized medical linguists is well-versed in the precise terminology and regulatory requirements of the life sciences industry. This expertise ensures that every revision upholds the highest standards of accuracy and clarity.

Additionally, Tomedes applies a tailored approach to language adaptation, carefully adjusting tone and vocabulary to suit specific age groups and readership contexts. This sensitivity is vital in medical translation, where comprehension can directly impact patient understanding and participation. All services are delivered under ISO-certified processes, providing clients with a reliable framework for quality assurance and documentation compliance.

The solution

To meet the client’s expectations for clarity, consistency, and professionalism, Tomedes applied a comprehensive and methodical approach to the revision process. Each step was carefully designed to align the revised documents with established linguistic standards while maintaining accessibility for diverse patient groups.

First, Tomedes conducted a meticulous side-by-side review of the translated clinical documents from Arm II against the previously finalized versions from Arm I. This comparison ensured that tone, structure, and phrasing remained consistent across all related materials. By referencing the accepted standards of Arm I, we maintained uniformity in the messaging and style across both study arms.

Second, our medical linguists carried out a comprehensive review of the oncology-related and general medical terminology used in the translations. Any discrepancies or ambiguous terms were revised to match the standard medical lexicon and improve clarity for patients and caregivers. This ensured not only technical precision but also better comprehension by non-specialist readers.

Last, we implemented consistent linguistic patterns and formatting to maintain readability across documents tailored for different age groups. Special attention was paid to syntax and structure, adjusting sentence complexity according to the comprehension level of each audience. This approach helped ensure that each document remained accessible while upholding professional and clinical standards.

The result

The revised documents demonstrated improved clarity and tone alignment tailored to each specific patient group, from children to adolescents and their parents. By simplifying or enhancing language appropriately, the revised content became more accessible and effective in communicating essential clinical information. This attention to readability ensured that each audience could engage with the material confidently.

Tomedes’ consistent and professional linguistic approach reinforced the trustworthiness of the client’s communication with study participants. The harmonized terminology and coherent formatting contributed to a more unified and credible presentation of the clinical materials. As a result, the client expressed high satisfaction with the outcome, laying the foundation for continued collaboration on future medical translation projects.

Conclusion

By expertly revising clinical trial materials from English to Spanish, Tomedes helped a clinical research organization ensure linguistic precision and patient-focused clarity. Our linguistic expertise, especially in regulated industries, supports global health communication. Contact Tomedes today to elevate your medical translation projects.