Clinical Trial Translation

Clinical trial translation is a specialised form of translation that focuses on converting documents and materials related to clinical trials from one language into another.

These translations are essential for ensuring effective global communication and research among researchers, participants and regulatory bodies.

Clinical trial translation requirements are governed by various strict international regulations to ensure patient safety and compliance, including the MHRA, EU CTR, ICH GCP guidelines, FDA, and more.

Generally, all documents intended for trial participants, such as informed consent forms, must be translated in the language(s) spoken by the participants. Documents submitted to regulatory authorities must also be translated into the official language (s) of the state where the trial is conducted.

In the UK in particular, the MHRA requires that participant-facing materials and regulatory submissions be provided in English or translated into other relevant languages for multilingual trials.

We provide language solutions in 220+ language pairs, including French, German, Arabic, Chinese, Korean and Spanish.

Explore our language options.

Yes. At Wolfestone, all our language services for clinical trials are carried out by professional linguists with subject-matter expertise in life sciences, clinical research, regulatory affairs, and more.

The chosen linguist(s) will be a native speaker of the target language and will hold a degree or relevant qualification in the desired field.

We provide accurate and compliant translations for a wide range of materials, including but not limited to:

• Informed Consent Forms (ICFs)
• Study protocols
• Case report forms
• Clinical Outcome Assessments (COAs/eCOAs)
• Lay summaries
• Patient interviews & surveys
• Regulatory documents
• Investigator brochures
• Patient Information Leaflets (PILs)
• And more.

Our language services are designed to meet the stringent requirements of international regulatory bodies, such as the EMA and FDA.

We work exclusively with linguists who are experts in medical terminology and clinical research. They possess a deep understanding of global regulatory standards.

Each project undergoes a multi-step, ISO-certified quality management process, which includes:

• Translation by subject-matter experts
• Thorough review and proofreading by secondary linguists
• Quality assurance checks and review
• Optional back translation, reconciliation and linguistic validation

Yes, we offer both back translation and reconciliation as part of our clinical trial translation services.

Yes, we offer linguistic validation. Our team will ensure translations are culturally appropriate and conceptually equivalent across languages.

We ensure terminology consistency by using advanced translation memory systems and custom-built approved glossaries.

Our approach minimises errors and maintain high-quality translation throughout your projects.

Yes, we support global multilingual trials and have the capability to scale our services to meet of complex, international projects.

Our project managers are experienced in managing large volumes of translations across multiple language, regions and time zones.

Whether you’re conducting research in one country or several, we can provide language support for every stage of the trial, from recruitment to regulatory submission.

Yes, we can handle rush requests and are equipped to deliver fast translations at scale.

The cost of translation varies depending on factors such as the number of languages, the complexity of the source texts, and the volume of content.

We offer customised pricing based on your specific needs and turnaround.

Contact us today for a free quote or explore our pricing guide.