Clinical Trial Translation Services and Research


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    Clinical trial translation services


    With important and groundbreaking medical research constantly taking place across the globe, professionalย clinical research translation servicesย are essential to sharing your important advances and gaining global standing, whatever your field of research.

    High quality clinical trial translation needs a combination of medical research expertise, technical knowledge and regulatory compliance understanding. Our translators are medically and scientifically qualified and adhere to technical standards, ethical guidelines and privacy regulations. This is not only important for international regulatory requirements but also for patient safety and protecting patient data. Our medical linguists use specialized translation and localization software to ensure consistency and accuracy throughout clinical trial content.

    • 90% of pharma or health care projects require clinical trial translations in 3 or more languages
    • 15,000 technical documents are translated annually for clinical trial communication
    • Poor translation accuracy can delay drug registration by up to 6 months
    • Clinical trial translation growth is 12.5% annually
    • 80% of clinical trial participants are from countries that require multilingual documentation

    These stats show why you should partner with a service provider that has quality control and experienced medical translators rather than risking trial results with poor translation resources.

    Service TypeTranslation services for clinical studies
    Supported LanguagesItalian, English, Spanish, French, German, Chinese, Japanese
    SpecializationMedical and scientific terminology
    Translation MethodProfessional human translation by medical, scientific and life sciences experts
    Delivery TimeVariable based on complexity and language (typically 3 to 7 days)
    Accepted FormatsWord documents, PDFs, study protocols, informed consent forms
    Quality AssuranceIncluded in the service, with review by experts in the medical field
    Additional ServicesCertified translation, scientific review, assistance with document preparation

    US Government Approved Healthcare Translation Services

    Healthcare translation in the US requires strict requirements to ensure patient safety, data accuracy and regulatory compliance.

    Key Requirements and Criteria:

    • FDA Compliance: Translations of medical devices, pharmaceuticals and biologics must follow the guidelines of the Food and Drug Administration (FDA) that controls medical devices pharmaceuticals and biologics. All translations must be accurate, clear, and consistent with the original source material.
    • GCP: Guidelines in Good Clinical Practice (GCP) stresses the need of reliable and accurate translations of clinical trials, including protecting patient safety and data integrity, top-quality translations of informed consent documents, clinical trial protocols etc.
    • ISO Standards: ISO 17100, which has a framework for stringent quality control management in the provision of translation services, is followed by many of healthcare organizations.
    • Qualified Translators: Medical translation requires healthcare translators to have in depth knowledge of medical terminology, cultural and regulatory nuances.
    • Confidentiality and Data Security: To protect patient privacy, HIPAA compliant translation service providers must have robust data security measures in place.
    • Translation Technology and Tools: When healthcare translation is used together with software translation memory, terminology databases, etc, the efficiency, consistency and accuracy of it can be increased.
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    What is clinical trial translation?


    Clinical trials are systematic medical studies that study new drugs and medical devices, or new therapeutic treatments. When these trials become global, clinical trial translation becomes key to the clinical trial process.

    Strict communication protocols are required for translation projects, both during early clinical phases and onward, across all clinical trial materials. That means translating clinical data, case reports, patient recruitment materials and clinical trial protocols. Translators must ensure clinical trial content is linguistically accurate as well as compliant with regulatory requirements across all target languages and that is facilitated by professional medical translators who work with a contract research organization (CRO).

    The biotech and pharma industry needs multilingual clinical documentation to:

    • Support clinical research in different locations
    • Meet international regulatory standards
    • Protect patient safety through clear communication
    • Collect data and analyze trial results
    • GCP across all sites

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    What are the phases of a clinical study translation?


    We have a structured workflow we follow including clinical accuracy and regulatory compliance for all of our deliverables to aid our clinical trial translation process. Hereโ€™s how:

    We begin with our linguists reviewing the technical documents to really understand the clinical trial content and develop the communications protocols. They then undergo a complete terminology review so they are in line with medical research and target language requirements.

    Then the translation phase starts where our medical translators translate the clinical trial materials into the target languages. According to international organization for standardization (ISO 17100) all translations go through a rigorous quality control process through a back translation and review by a second linguist.

    This streamlined process allows us to deliver clinical trial translations fast and with the highest medical translation standards. Our proven process is efficient without compromising the quality required by pharma and CROs.

    What documents need to be translated in clinical research?


    Our medical translation services cover all aspects of clinical trial content and clinical research translation needs. We provide full translation and localization solutions for the following clinical trial materials and technical documents:

    Scientific and Research Documentation

    • Ranging from scientific papers to research reports
    • Medical-scientific theses and academic papers
    • Case reports, and clinical trial protocols
    • Trial results and clinical data
    • Process documentation

    Patient-Related Materials

    • Diagnoses, professional medical opinions and medical reports
    • Healthcare documents and patient records
    • Vaccination certificates
    • Patient leaflets, medication information

    Medical Device Documents

    • Procedural documents and user manuals
    • Safety protocols and instruction manuals

    Our network of medical translators and linguists provides clinical trial communication in all languages to international clinical standards and regulatory requirements. We have our own CROs with whom we work and the pharma industry, and control quality throughout the translation project lifecycle.

    Example of a certified translation of a clinical study

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    Why translation is important for clinical trials?


    Translation of international clinical trials helps medical research and patient safety across the board between pharmaceutical industry sponsors, CROs, researchers, and regulatory authorities. Therefore, professional translation services are much needed.

    Certified clinical trial translation services support multiple key objectives:

    Regulatory Compliance: All clinical trial protocols meet international regulatory standards.

    • Health authority submissions
    • Regulatory translation
    • GCP across regions

    Research Teams and Sponsors

    • Clinically relevant data exchange between international sites
    • Clinical research translation consistency
    • Biotech companies communicating with research teams

    Patient Safety and Participation

    • Information for patient recruitment
    • Translation of informed consent documents
    • Documenting patient data protection

    When translating for medical purposes, our medical translators use language suitable to the reading audience: informal language for patient material, technical language for clinical working documents, and more formal language for regulatory documents. We control quality throughout the translation of trial results and associated documentation.

    How much do clinical trial translation services cost?


    Generally, a translation of a clinical study into English costs about โ‚ฌ50 per page.

    The cost of clinical study translations depends on several factors. Let’s look at the most relevant ones:

    • Language combination: translating into a widely spoken language like English or German will cost less than translating into a rare language like Hungarian or Urdu. It is not a matter of language complexity but of translator availability.
    • Text length: some studies are very voluminous; in such cases, a flat fee is generally applied.
    • Type of text: if the material to be translated is extremely technical and complex, the cost might increase as a particularly experienced translator would be necessary.
    • Delivery requirements: ultra-fast delivery โ€“ a service offered by Espresso Translations โ€“ has a higher cost as it involves greater resource allocation to the work in question.

    Obtaining more precise information and having a clear understanding of the expenses is very simple: just submit a quote request using the contact form on Espresso Translations’ homepage, attaching the documentation to be translated and specifying each requirement. The response โ€“ absolutely free โ€“ will arrive within a few hours.

    How long does it take?


    It depends on the type of document (clinical trial protocol or patient safety report), languages involved, document length and format.

    We have made a name for ourselves by delivering translations on time โ€“ every time. As mentioned above there is an ultra fast delivery service for special needs. For more info just write to Espresso Translations and we will find the solution for your case.

    What do our clients say?


    Our company is an accredited translation provider that does clinical trial translations, and offers full support and guidance from our project managers to customers that require either small or large translation projects.

    I highly recommend Espresso Translations and their medical translation services. Their medical translators are very professional and knowledgeable.

    โ€“ Laura

    Good customer service and confidentiality/data security. Translations are precise and show understanding of medical terminology.

    โ€“ Marco

    Where to find certified translators for my clinical trial?


    Get a translator for your clinical trial without having to visit multiple agencies in person. Espresso Translations is online and a clinical trial translation leader.

    For your clinical trial translation, Espresso Translations is the perfect choice:

    • Professional medical translation services: A key benefit is our native speaking experts in clinical translations who have the right language and translation skills and years of experience needed for such work.
    • Latest translation tools: Technology knowledge and expertise to deliver consistent high quality clinical language translations.
    • Fast Turnaround: We are fast without compromising translation quality.
    • Competitive Pricing
    • ISO quality translation management systems.

    Get a quote. Accept it, pay, get your translations on time as agreed.

    Partner with a team of experts in clinical trial language solutions


    Partner with Espresso Translations and you get access to a network of medical translators and patient data experts. Our language solutions cover all your medical documents, clinical trial protocols, informed consent forms, patient recruitment materials. We will meet your needs. Contact us today to find out how our clinical trial translation services can help you.

    At Espresso Translations, our clinical research translation services are completed by qualified translators who have advanced, up-to-date knowledge of the medical sector, meaning we guarantee an accurate, fluent and technically proficient translation of any documentation relating to your clinical trial.

    Our commitment to excellence means we work exclusively with knowledgeable and experienced mother tongue translators. They focus their skills on ensuring your translation reads fluently to other native speakers and is presented in a clear, readable style that stays true to the original document, whether itโ€™s packed with figures or complex technical vocabulary.

    Our clinical research translation agencyโ€™s commitment to completing translations on time, every time, means you can rest assured that any further stages of your project waiting for clinical trial translations can continue to run smoothly and on schedule.

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    Frequently Asked Questions


    Are there specific rules for clinical trial document translation?

    Of course there are special rules for translating clinical trial documents. These rules ensure accuracy, consistency and prevent clarity errors in translated documents. Some of the rules and standards are:
    Good Clinical Practice (GCP): An international ethical and scientific quality standard for the design, conduct, recording and reporting of clinical trials on human subjects.
    International Conference on Harmonization (ICH) guidelines: These guidelines define the quality, safety and efficacy framework for pharmaceuticals and bio/pharmaceuticals.
    ISO 17100: This standard covers translation services. Terminology management, quality assurance procedures and translator qualifications.

    What should a translator of scientific texts have?

    In addition to full command of the languages they are working in, academic training and proven attendance to specific courses, a scientific translator should have:

    – Clarity: Ability to express complex scientific information in the target language.
    – Scientific terminology: Understanding the use of abbreviations, acronyms, and other subject matter vocabulary.
    – Translation tools: Expertise to deal with glossaries, dictionaries and translation memory software.
    – Continuous professional education andย development: Translators must stay up to date on the latest scientific and medical advancements and changes in regulatory frameworks.

    What are the challenges in clinical studies translation?

    Clinical studies translation challenges are different from one project to another. Maybe the most common is to keep the meaning and intent of the source text in the target language. Requires accuracy and subject matter expertise.

    Another challenge is to make the translated materials understandable to the recipients. This may mean adapting the language and style for different stakeholders: researchers, patients or regulatory authorities.

    Finally clinical trials integrity relies on consistency in terminology and style across all translated documents. This requires coordination of terminology databases and style guides. Something only high quality clinical trial translation services can do.

    Clinical trial success and the subsequent medical and pharmaceutical product development process relies on accurate and trustworthy translations for patient safety, data integrity, and regulatory compliance.

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