Clinical Trial Translations: How to Ensure Flawless Accuracy?

What happens when a medicine, ready for global trials, gets rejected because of a single mistranslated text in the participants’ clinical trial documents? Imagine the years of research, testing, and money invested in creating the drug, only for it to never see the light of day—all because of a translation error. This scenario not only emphasizes accuracy in clinical trial translations but also the weight of each word used in the reports.

In this blog, we will explore why clinical trial translations must be spot-on and how to ensure 100% accuracy.

Importance of Accuracy in Clinical Trial Translations

Since the turn of the century, globalization has significantly changed in clinical trials. According to the World Health Organization (WHO), only 20% of global clinical trials are conducted in the USA, followed by China (15%) and India (8%). Such diversity in language across these nations has created a boost in demand for accurate clinical trial translation. This means that documents, like informed consent forms, case reports, protocols, medical history, and observation reports, must be translated into different languages and adapted according to their local laws.

Failing to provide accurate clinical trial translations may lead to:

• Patient non-compliance
• Misinterpreted medical instructions
• Severe regulatory pitfalls
• Legal liabilities
• And worse: physical harm to participants

The fact that accuracy in clinical translation isn’t just about converting complex medical words but also about adhering to legal and cultural nuances makes the procedure even more difficult.

5 Steps to Achieve Flawless Clinical Trial Translations

Follow these steps and ensure the highest accuracy possible in translating all types of clinical trial documents.

• Partner With A Professional Translation Company

This is perhaps the most important step. Clinical trial documents contain heavily specialized terms, which cannot be converted using regular bilinguals. Hence, it is highly advisable to only partner with reputable and reliable healthcare translation services.

If you are looking for a company in Delhi, India, or elsewhere, do ensure that

• The company offers native linguists who are highly proficient in the medical domain.
• The company possesses the right certification, such as ISO 17100:2015, ISO 13485:2016, ISO 14971:2019, etc.
• The company has previous experience with clinical trial translations.

• Implement Regional Differences

Several medical terminologies can be ambiguous; they can have different meanings in different languages. Hence, a literal word-for-word conversion won’t be enough to ensure translation requirements for clinical trials.

To avoid these mistranslations, ensure

• Only native linguists are used on medical documents.
• A special glossary has been created to identify complex and ambiguous words.
• Culturally sensitive terms are translated with total clarity.

• Use an Efficient Translation Strategy

An efficient translation strategy is the foundation of deriving high-quality results.

Always ensure

• Partnering with one clinical trial document translation company rather than multiple.
• Leverage the use of protected or encrypted translation memory tools to boost consistency.
• Create a standardized database to accurately translate dense medical terms.

• Strict Quality Check and Validation Process

One must not undermine the importance of quality when it comes to clinical trial documents. Healthcare providers or clinical trial institutions would expect high-quality translation, which can be understood by the participants.

Ensure that the hired translation agency follows strict quality assurance steps, such as

• Rigorous review and linguistic validity of initial translations.
• Cognitive debriefing for patient-centric content.
• Forward and back translation to ensure appropriate content.
• Client feedback to boost productivity.

• Be Mindful of Regulatory Requirements

In the medical domain, laws set by regulatory bodies differ from region to region. For example,

• The European Medicines Agency (EMA) mandates strict adherence to EU MDR policies.
• The US Food and Drug Administration (FDA), in some cases, asks for Spanish translations for its Hispanic population.
• The Central Drugs Standard Control Organization of India requires all clinical trial documents to be submitted in the scheduled languages of India.

It is essential that the translation company you have partnered with is familiar with these laws and regulatory bodies.

Like clinical trial translations, pharmaceutical translations are also quite challenging. Along with top-notch accuracy, linguists need to ensure several things. Curious to know more about these challenges? Check out this blog: Pharmaceutical Translations: Some Common Linguistic Challenges!

Translate Beyond Medical Terminologies

We have learned how important accurate translations are in clinical trials. Every sentence of a clinical trial document carries a weight of patient well-being and regulatory adherence. Hence, for flawless clinical trial translation and to ensure life-saving drugs and devices reach beyond borders, it is necessary to partner with a professional language service provider, like Somya Translators.

We are certified under ISO 17100:2015, have extensive experience of 16+ years in the medical domain, offer top-class native linguists, and ensure strict data protection policies along with quality review.

Our professional life-sciences linguistic services include

• Forward Translation of Medical Documents
• Double Review
• Reconciliation
• Back Translation
• Comparative Review Equivalency
• Clinical Review
• Cognitive Debriefing
• Linguistic Validation for Clinical Trials
• And Medical Interpretation Services

So, ensure that your next clinical trial avoids any translation roadblocks by partnering with us, Somya Translators.

You won’t regret it, because
“You Say It, We Do It.”

Contact us today to explore how we can assist your medical linguistic needs!