Clinical Trial Translation: Precision Is Key Imperial Clinical Research Services Blog

Carlton Vedel

Sep 10, 2025 • 5 min read

In this article, we will delve into some of the best practices for translating PROMs that can help enhance the validity and reliability of clinical trial outcomes. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) may require certified translations of your clinical trial documents. DTP services ensures all submissions, reports, and materials meet the legal and linguistic standards set by each jurisdiction. Sesen specializes in high-quality, regulatory-grade translation services tailored to the life sciences industry.

What is Legal Document Translation?

Undeniably, accurate translation of study documents by native speakers from each country or locale plays an important role in the success of trials in any particular region. However, not all documents related to clinical trials involve highly technical content, and the recipients of the translation must be taken into account. For instance, in order to standardize the conduct of the trial and to facilitate communication between all the individuals involved, several types of instructions, which may be placed in an appendix or in the data collection forms, can be created. Another objective for overhauling patient consent guidelines, aside from enhancing the safety of the trial participants, is to promote patient involvement to foster a more inclusive environment for conducting clinical trials in the EU.

In today’s global healthcare environment, accurate medical document translation ensures clear communication across borders.
Benefits of back translation include enhanced transparency and the ability to detect potential translation errors or omissions.
While machine translation is cost-effective, especially for handling large documents, it can stumble when handling cultural nuances and is typically unable to recommend appropriate local deviations from the source content.
However, teams that understand the risks involved with inaccurate translation can anticipate their language needs proactively and better control for any pain points.
This means that sponsors of clinical trials in the EU must make sure that all relevant documents are translated into the languages spoken by the trial participants.

Translating Regulatory Documents: Best Practices and Common Pitfalls

Clinical trial translation is a specialized area that involves translating a wide range of documents, including protocols, informed consent forms, patient information sheets, and case report forms. Court documents, including court transcripts, witness statements, and legal pleadings, often need to be translated for legal proceedings involving parties who do not speak the language of the original document. Accurate translation of court documents is essential to ensure that all parties involved can understand and participate fully in the legal process. Professional legal translation services have certified translators who specialize in legal jargon and can provide accurate translations of court documents for different legal systems. The rights and safety of clinical trial participants and patients must always be protected. Accurate translations overall reduce medical error through the clinical journey and when the medication is on the market.

Leverage Technology While Prioritizing Human Expertise

Sesen means ‘reborn,’ reflecting how we help life sciences organizations improve patient lives around the world through expert language communications. Every project is managed by a dedicated clinical project manager, supported by experienced QA specialists who oversee each step of the workflow. Our linguists are native-speaking professionals with domain expertise in therapeutic areas such as oncology, CNS, rare disease, and infectious disease. A localized translation considers cultural nuances that may influence how health-related information is interpreted. For example, certain dietary instructions, symptom descriptions, or lifestyle restrictions may need adjustment to reflect local habits and expectations. The translation approach must emphasize clarity, precision, and cultural sensitivity, helping meet these expectations across diverse populations.

You’ve invested millions, if not billions, in R&D for the development of new drugs and medical devices, and the last thing you want is to work with an average translation company for your clinical trial translation requirements.
Also important is the role of native speakers in maintaining cultural relevance and linguistic authenticity.
Medical translators are increasingly expected to possess a deep understanding of medical terminology, cultural nuances, ethical considerations, and evolving technologies.
However, that very same trait can become a challenge when they do not easily complain or report adverse events.
Certified translations are professionally translated documents accompanied by a signed statement from the translator or translation agency affirming that the translation is accurate and complete to the best of their knowledge.

Utilize Certified Translators for Official Documents

As highlighted throughout this guide, medical translation is a specialized field that demands not only a strong command of the source and target languages, but also a deep understanding of medical terminology, concepts, and cultural nuances. Ultimately, the translation of clinical trial documents is a complex process that requires a delicate balance between precision and compliance. Quality assurance, privacy considerations, and ethical practices play pivotal roles in ensuring that translations meet the highest standards of regulatory adherence. Maintaining consistency across translated clinical trial documentation begins with robust terminology management. Clinical trials involve highly specialized language, including medical terminology, regulatory phrasing, and scientific expressions that must be translated with precision.

Best Practices for Linguistic Validation in Multinational Clinical Trials

The CTR states that all documents related to a clinical trial must be translated into the language(s) of the trial participants. This means that sponsors of clinical trials in the EU must make sure that all relevant documents are translated into the languages spoken by the trial participants. Moreover, the EU CTR requires that all documents submitted to regulatory authorities in the EU must be translated into the official language(s) of the member state where the trial is being held. By making translation services easily accessible to bilingual subject matter experts such as doctors and clinicians in addition to professional translators, Stepes is able to deliver multilingual translations for results that are better than ever. Stepes makes it possible for language translation services to be performed anytime and anywhere on mobile phones or desktop computers alike, delivering unrivaled flexibility and scale that modern international clinical trials demand. Conducting clinical research in one language is already a challenge; the last thing you want is to manage the same clinical studies in multiple languages like Simplified Chinese, Spanish, and French.

Pharmacy Deserts and Language Barriers: A Double Threat to Patient Health

Passionate professionals specialized in the medical field know that, to stay relevant, they need a comprehensive understanding of technical terminology, cultural nuances, legal compliance, medical accuracy, and ethical considerations. This comes with a large dose of professional commitment, collaboration, and ongoing learning that, in time, will secure patient safety and confidentiality through accurate and reliable translations. Clinical trials operate across global regulatory environments, requiring precise translation of informed consent forms, protocols, and safety data. A mistranslation of medical terminology—such as underrepresenting the severity of potential side effects—can lead to misinformed participants, non-compliance with regulatory bodies, and legal repercussions.

We hope this article will be useful to those who, due to their activities, deal with translation of materials for clinical studies. The certification proves that the translation can be relied upon for legal and official purposes, giving it legal weight and authenticity. Certified translations are essential for legal matters, official documentation, and compliance with legal requirements. Translation ensures that documents are accessible to individuals who do not speak or understand the language of the original document. It also enables legal professionals, such as lawyers, judges, and advisors, to access information from different legal systems and jurisdictions. By understanding the process and best practices, you can ensure accurate and reliable translation of your documents.

Gain Access to Healthcare Virtual Assistant Experts

The need for accurate translation of clinical trial documents also extends to informed consent forms, study protocols, and patient information sheets, which must all be translated correctly to avoid misinterpretation and ensure participant safety. In the rapidly evolving field of clinical research, the translation of clinical trial documents plays a critical role in ensuring the global reach and integrity of studies. Organizations conducting clinical trials often engage with a diverse group of patients. Additionally, clinical trials can expand across borders, making the need for precise and compliant translation of trial documents paramount. In global clinical trials, even a small mistranslation can threaten patient safety.