1. Regulatory Non-Compliance

Regulatory authorities like the FDA (U.S.), EMA (Europe), and PMDA (Japan) require precise documentation in their native languages. If translated documents, such as an informational brochure or an Informed Consent Form, contain errors, it could result in a rejected submission or a clinical hold. Both of which will likely cost additional time and resources.

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For example: If a dosage instruction is mislabeled due to incorrect translation for one country, that might be flagged by regulators as a safety concern, forcing the sponsor to retranslate and resubmit documents, which could put a hold on administering the therapy for all regions until a correction and reapproval are complete. 

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2. Patient Safety Risks

Informed Consent Forms (ICFs) are designed to help participants understand the risks and benefits of a clinical trial. Poor translation can leave patients confused, fearful, or misinformed. This would severely decrease potential participants' willingness to join the trial, leading to extended trial times and difficulty in reaching participant diversity goals. 

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For example: There is an inaccurate translation of "mild" and sever" in an informed consent section of a clinical trial translated to Spanish. The original version stating the "mild" side effects of the treatment and the Spanish version reading "serious" side effects, leading to a disproportionate amount of Spanish-speaking individuals opting out of participation due to believing the treatment posed high health risks. Underscoring why high-quality, patient-facing life sciences localization is critical and ethically paramount.

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3. Data Integrity Compromises

Consistency in translated Case Report Forms (CRFs) and questionnaires is key to collecting reliable data. If terminology varies across sites due to poor translation, it can compromise the study's results.

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For example: A multinational trial used different translations of a pain scale, leading to participants interpreting it differently, making it impossible to compare responses across regions. This would potentially lead to inaccurate and skewed results based on region, when that may not be the case at all. 

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4. Brand and Reputation Damage

Errors in translation reflect poorly on the sponsor’s professionalism and reliability. In a market dealing with people's lives, your brand can’t afford to be associated with poor-quality work because, often times poor-quality work directly affects the patients involved. Putting people first is a way to ensure your patients are safe and well cared for, and understood, and that can start with accurate translations. 

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How Ribolexi Helps

At Ribolexi, we specialize in clinical trial translation and life sciences localization, ensuring every document is accurate, compliant, and culturally appropriate. Our linguists are subject-matter experts who understand both science and language, so you can focus on running successful, global trials and treating patients.

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Ready to reduce risk in your next clinical study?

Let’s talk about how Ribolexi can support your clinical trial translations on time, on budget, and on point.

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