Clinical Trial
Translation Services

LanguageExpress™ is designed for high-volume clinical workflows, where large sets of structured, finalized content need to be translated quickly and consistently. It automates repeatable translation processes, applies approved terminology consistently, and delivers outputs in hours instead of days. Clinical linguists then review and validate translations, focusing their expertise where it adds the most value. 

LanguageNow™ is BIG Language Solutions’ technology for instant translations, providing secure, on-demand translation for lower-risk, time-sensitive content, such as internal updates or site-level communication. This ensures that language is never a barrier to clinical trial continuity, without introducing risk into regulated documentation. Unlike public tools, it operates within a protected environment, making it secure for sensitive clinical data such as patient communications and site instructions.

We can provide expert translation for all in-trial documentation, including: 

• Protocol Synopses
• Adverse Event Reports (AERs)
• Patient Diaries & Questionnaires
• Interim and Final Study Reports
• Electronic Patient Reported Outcomes (ePROs)
• Quality of Life (QoL) Instruments
• Clinical Outcome Assessments (COA)



We also translate supporting documents, for example: 

• Drug labels & Inserts
• Literature abstracts
• Discharge summaries

We support clients through the full lifecycle of drug and medical device development beyond clinical trials, including pharmacovigilance and real-world evidence collection. Discover more translation services for the life sciences sector. 

Large-scale translations for clinical trials require banks of pre-approved terminology, especially for complex, ambiguous, or risk-sensitive terms. 

Neural machine translation processes large volumes of translated documents and is supported by structured terminology management processes, including automated term extraction and linguist validation.

This ensures that key clinical terms, drug names, and measurements remain consistent across large document sets and multiple study phases.

Our approach is built around precision: automating repeatable, structured content while preserving full human control over complex, high-risk clinical materials.

Neural machine translation (NMT) is integrated into our workflows only for content that is finalized, structured, and suitable for repeatable processing, such as standard clinical trial documentation and high-volume materials.

All NMT outputs are subject to human validation by clinical linguists, ensuring accuracy, correct interpretation of medical terminology, and full alignment with regulatory expectations.

BIG Language Solutions uses proprietary software, LanguageExpress™. This custom, tech-enabled workflow delivers high-quality translations in hours rather than days, which is a critical advantage for time-sensitive clinical trials.

LanguageExpress™ uses a strategic approach to human review: rather than applying manual labor by default to every string, the system utilizes automated pipelines to handle standardized content, deploying expert clinical linguists only where they add the most value, such as in complex medical narratives or ambiguous terminology. This creates a predictable turnaround time and ensures that approved language is applied consistently across thousands of documents, providing the audit-ready reporting that clinical researchers require.

Complementing this is LanguageNow™, an instant, secure translation tool powered by custom Neural Machine Translation (NMT) engines.

Unlike generic public tools that pose massive security risks to sensitive clinical data, LanguageNow™ resides within BIG’s secure environment and uses domain-specific engines that are far more accurate for clinical terminology than one-size-fits-all models.

Neural machine translation is not applied to complex or high-risk clinical content, including:

• Documents containing tracked changes or reviewer comments
• Content requiring strict preservation of formatting and annotations
• Materials subject to detailed regulatory review

In these cases, translation is performed and reviewed entirely by specialist clinical linguists to ensure full source fidelity.

For example, LanguageNow™ provides fast, secure translation for time-sensitive communications such as site instructions or internal updates. But it is not used for regulated submission content – only for controlled scenarios where speed is required, and risk is low.