Translation Strategies for Safe, Cost-Efficient Clinical Trial Content

Pharmaceutical, biotechnology, and medical device organizations cannot afford translation errors. A single mistranslated word on a product label, medical instruction, or clinical document can cost millions, delay approvals, and even put patient lives at risk.

Learn the key translation risks, strategies, and solutions that life sciences leaders need to know for flawless content localization. By developing a comprehensive translation strategy for each of your markets, you can take steps to protect patients and avoid the consequences of medication errors, adverse drug reactions, and pharmacovigilance failures.

Author: Jess Eker, SVP Global Life Sciences Practice

Special Thanks to Contributing Experts:

Katie Lewis, Vice President, TransPerfect Life Sciences

Alex Farrell, Regional Director, TransPerfect Life Sciences

The Impact of Accurate Translation

From lab to launch, reliable translation is critical in global markets. Local language experts, translation technologies, and localization processes work together to drive success in:

Patient Comprehension

As pharmaceutical companies operate in multiple markets, it is crucial to ensure that information is clearly understood in every region. Accurate translation enables both medical professionals and patients to access the correct information, promoting better health outcomes.

Regulatory Compliance

Translation in each target region requires specialized local regulatory knowledge, native fluency, and deep understanding of industry terminology and practices.

Product Quality

Minor translation errors can lead to major manufacturing failures, affecting the efficacy and safety of medical products. Precision in translation ensures that all communications support product integrity and patient safety.

Common Translation Risks

A single error in translation can cascade through the entire product lifecycle, resulting in severe regulatory and operational setbacks. Key risks include:

ClinOps

Compromised Patient Safety

Inaccurate translations in patient information leaflets or dosage instructions can result in life-threatening mistakes.

Delays in Regulatory Approvals

Mistranslations in regulatory submissions can lead to extended review times and delays in product launches, disrupting go-to-market strategies.

Financial and Legal Repercussions

Pharmaceutical companies may face hefty fines, penalties, or even legal action for non-compliance stemming from translation errors.

LMS and eLearning

Damaged Reputation

The credibility and reputation of a company can suffer greatly from translation mistakes, undermining years of brand trust and market standing.

Examples of Real-World Impact

Miscommunication—whether on drug labels, dosage instructions, or technical manuals—can lead to dangerous or even life-threatening errors. Translation mistakes can trigger costly and dangerous outcomes in both the pre- and post-commercialization phases.

Here are several real-world examples which reveal the true impact of inadequate translation:

Incorrect Drug Ingredients

Inaccurate translation can lead to dangerous and life-threatening errors in drug commercialization. A Chinese drug manufacturer faced regulatory repercussions and an FDA warning after shipping an over-the-counter product to the U.S. containing the wrong active pharmaceutical ingredient (API). Due to a translation mistake, dexamethasone acetate was used instead of hydrocortisone. This error damaged the manufacturer's reputation and raised serious concerns about patient safety. (FiercePharma)

Erroneous Prescription Labels

A study in New York found that pharmaceutical labels, including usage instructions, were translated incorrectly nearly 50% of the time, posing significant health risks to non-English-speaking patients. In one case, a mother misinterpreted dosage instructions for her daughter’s antibiotics due to mistranslation, leading to over-administration. Such errors often arise from words like “once,” which in Spanish means “eleven” instead of “one time”. (NIH)

Comprehension-Based Overdosing

A study published in the Journal of Academic Pediatrics highlights how non-English-speaking populations in the U.S. often struggle to understand medical instructions due to a lack of accessible translation services in pharmacies. Language barriers place Limited English Proficient (LEP) families at higher risk of adverse medical events. The study found that Hispanic parents with LEP made more dosing errors than their English-speaking counterparts, even when medication labels were in their preferred language. (NIH)

Patient Treatment Risks

Mistranslations in documentation can result in incorrect instructions, miscommunication of adverse effects, and inaccurate reporting, particularly in multinational clinical trials. In one case, a major scandal in France from 1989 to 2006 involved hundreds of cancer patients receiving excessive doses of radiation due to errors at two radiotherapy units. The instruction manuals for the radiotherapy machines were in English, which the French staff couldn’t fully understand, leading to fatal mistakes and lifelong injuries for patients. (BBC)

Common Causes of Translation Mistakes

The failure to mitigate risks in localization is all too common. If your company is struggling to localize content accurately and cost-effectively at scale, you are probably dealing with at least one of these six common issues. Fortunately, there are ways to avoid these common translation failures and their associated consequences.

1. Literal Translation: Word-for-word translations can result in nonsensical phrases or incorrect terminology, such as translating “cardiac arrest” as “heart imprisonment.”

4. Insufficient Capacity: A team that does not have sufficient elasticity to ebb and flow with content needs is likely to shortcut translations and minimize the importance of due diligence in reviews during busy times. Translation services companies give teams the on-demand capacity to scale up and down with content needs without over-hiring.

2. False Cognates: False cognates and false friends are words that look or sound alike across languages but have different meanings, often leading to confusion or misinterpretation.

5. Missing Cultural Nuance: Every culture has specific nuances which are often lost on foreigners, even on those who are otherwise fluent in the local language.

3. Low Subject Matter Expertise: Inexperienced translators unfamiliar with the pharmaceutical, biotechnology, and medical device industry can inadvertently introduce errors that compromise accuracy.

6. Lack of Translation Technology: Without a modern translation platform, even fluent subject matter experts struggle to collaborate and deliver consistent, accurate translations.

Best Practices for Flawless Translation

Effective localization relies on two pillars: talent and technology. Your approach in each region should include native translators, medical writers, and regulatory consultants (talent) all collaborating within an AI-powered translation management system (technology). Without strong pillars in place, organizations face significant challenges and risks.

While technology is a key contributor to streamlined translation processes, the expertise of human translators remains invaluable. Local translators with a deep understanding of industry language provide key oversight for accurate and contextually relevant translations - and supplementing human expertise with industry-trained AI can enhance speed and accuracy.

Here are five keys to building strong pillars of translation technology and talent:

Work with Expert Native Translators: Native translators with life sciences proficiency can bring essential insights into language intricacies and cultural nuances. The result? More accurate and contextually appropriate translations.
Centralize Terminology with Translation Memory: Translation Memory stores previously translated phrases and terminology, helping maintain uniformity, improve accuracy and reduce the cost of translation.
Scale with AI Translation: Produce translation at scale by empowering your talent with AI solutions to streamline their translation efforts.
Implement Rigorous Translation Review: Have local subject matter experts review every translated document to ensure accuracy, adherence to regulatory standards, and linguistic precision.
Collaborate in a Translation Management System (TMS): A TMS provides a central cloud-based platform which automates manual processes, supports consistency with central linguistic assets and translation memories, increases efficiency with machine translation (MT) workflows, and offers real-time reporting for greater visibility and control. The TMS is essential for consistent, successful content localization.

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Product Launch and Commercialization Translation

As products move from research to market, the need for accurate, localized content becomes essential. Whether it’s product labels, patient information leaflets (PILs), or marketing materials, translations must be both precise and culturally attuned to each market. Ensuring compliance with regional regulatory bodies and maintaining clear, persuasive messaging is vital.

More Product Commercialization Solutions

Product Labels (IMP and AMP Labeling):

Ensure all necessary product information is clearly communicated and compliant with local regulations.

Patent Translations:

Safeguard your intellectual property in regional markets with confidential patent localization.

Patient Information Leaflets (PILs):

Provide clear instructions on usage, safety, and side effects to help patients understand how to use your product safely.

Marketing Materials:

Engage global audiences with accurate, localized marketing materials that resonate across cultures.

Safety Data Sheets (SDS):

Ensure safe handling of chemicals by translating safety data sheets accurately for every market.

Compliance Documentation:

Ensure compliance with evolving global regulations by accurately localizing content including reports, data sheets, and applications.

Post Market Surveillance Reports:

Accurately track product performance and safety once products are on the market, ensuring compliance with post-market reporting requirements.

Training Materials:

Provide culturally adapted training resources to equip healthcare professionals and staff across regions to handle product administration, safety protocols, and patient care.

Web Localization:

Tailor your website content for local markets to engage healthcare professionals and patients with accurate information in multiple languages.

Digital Health (app translation/localization):

Translate and localize digital health applications to comply with regional regulations and improve user experience for patients and healthcare providers.

Scientific Publications:

Accurately translate research findings to facilitate global dissemination of scientific knowledge and ensure compliance with local medical and regulatory standards.

Clinical Trial Translation

In the early stages of product development, accurate translation is critical to ensure smooth regulatory submissions, effective communication with trial participants, and compliance with local laws. From clinical trial protocols to informed consent forms (ICFs), precision and cultural understanding are key to avoiding delays and ensuring the integrity of your research.

Clinical Trial Protocols:

Ensure that trial designs and procedures are clearly communicated to all participants and regulatory bodies.

Informed Consent Forms (ICFs):

Protect patient rights by ensuring consent documents are clear, culturally appropriate, and legally compliant in every language.

Clinical Trial Disclosure and Investigator Brochures:

Provide researchers with accurate and consistent documentation on investigational products.

Regulatory Submissions:

Facilitate timely approval processes by delivering accurate, regulatory-compliant translations.

Clinical Outcome Assessments:

Ensure that patient-reported outcomes and other clinical data are accurately translated to maintain the integrity of trial results and ensure proper interpretation across regions.

Training (e.g. SOP):

Localize standard operating procedures (SOPs) and training materials to ensure that clinical staff worldwide understand and adhere to correct protocols.

Informed Consent Forms:

Guarantee patient understanding by providing culturally relevant and legally compliant translations of consent documents in all necessary languages.

Adverse Event Reports:

Deliver precise translations of adverse event documentation to comply with regulatory requirements and safeguard patient safety.

Case Report Form:

Translate case report forms accurately to ensure data integrity and reliable trial results across multiple regions.

Simplify Your Global Content Translation with TransPerfect

Translation errors can have catastrophic consequences for patients, sites, and sponsors.

Accuracy is mission-critical, which is why over 6,000 organizations across the world rely on TransPerfect for their content localization needs.

TransPerfect Life Sciences delivers precise pharmaceutical, biotechnology, and medical device content translation in 200+ languages from offices in 140 cities across 6 continents.

Contact us today to discuss your translation needs with the life sciences experts.