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Clinical trials and linguistic validation translation services

Specialist translation and linguistic validation support for international clinical research
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In clinical research, every word matters. Whether you’re communicating with trial participants, preparing clinical documentation or adapting patient questionnaires for use in different countries, accurate translation is essential.

At Atlas Translations, we support pharmaceutical companies, clinical research organisations (CROs), universities and research teams with specialist clinical trial translation and linguistic validation services.

From participant information sheets and informed consent forms to Clinical Outcome Assessments (COAs), we understand the importance of scientific accuracy, patient comprehension, cultural appropriateness and consistent terminology.

We’ve been providing professional translation services since 1991, combining experienced specialist linguists with careful project management and quality assurance.

Need help with clinical trial translation or linguistic validation? Talk to our team at team@atlas-translations.co.uk. We’ll be happy to discuss your project, explain the options and provide a detailed quotation.

Clinical trial translation services

Clinical trials generate a wide range of documentation, often involving different audiences, countries and regulatory requirements. Some materials are written for researchers and healthcare professionals. Others must be accessible to patients and trial participants, who may have little or no medical knowledge.

We help ensure that translated materials are accurate, appropriate for their intended readers and consistent across languages.

Documents we can help translate include:

  • Clinical trial protocols and protocol amendments
  • Participant information sheets (PIS)
  • Informed consent forms (ICFs)
  • Patient questionnaires and surveys
  • Clinical Outcome Assessments (COAs)
  • Patient-reported outcome measures (PROMs)
  • Patient diaries and symptom reporting materials
  • Investigator brochures
  • Clinical study reports
  • Study recruitment materials
  • Research correspondence and supporting documentation
  • Training materials for investigators and research teams
  • Safety information and patient communications

Our project managers select professional linguists with relevant medical, scientific and clinical research expertise, taking account of the document’s purpose, audience and terminology requirements.

Linguistic validation of clinical outcome assessments

Clinical Outcome Assessments (COAs) are used in clinical research to measure how patients feel, function or respond to treatment. These assessments may include patient questionnaires, symptom diaries and other instruments designed to capture information about a patient’s health or experience.

When an assessment is used across different languages and cultures, translating the words alone may not be sufficient. Linguistic validation helps establish whether the translated assessment preserves the intended meaning and concepts of the original.

Atlas provides specialist translation and linguistic validation support for COAs, including patient-reported outcome (PRO) instruments and other patient-facing assessments.

Our linguistic validation services

Depending on the instrument, methodology and project requirements, our work can include:

Forward translation

Translation of the original assessment into the target language by appropriately qualified linguists, with attention to conceptual meaning, terminology and patient comprehension.

Back translation

Translation of the target-language version back into the source language, typically by an independent linguist who has not worked on the forward translation. This provides an additional means of identifying potential differences in meaning.

Reconciliation

Review and comparison of translations to resolve differences, assess alternative wording and produce an agreed version.

Review and resolution of translation queries

Our project managers coordinate linguistic queries and feedback, helping to resolve potential ambiguities and maintain consistency throughout the process.

Proofreading and linguistic quality assurance

Careful review of the translated materials, including terminology, consistency, accuracy and formatting.

Documentation and version control

We can support projects requiring documented translation decisions, structured feedback and careful management of successive versions.

Where a linguistic validation methodology requires cognitive debriefing with patients, this stage is arranged separately by the client or their appointed research partner. Atlas can support the associated translation work and subsequent linguistic revisions.

Why human expertise matters in clinical research

Clinical trial translation is not simply a matter of replacing medical terminology with equivalent words in another language. A phrase that is technically accurate may still be difficult for a patient to understand. A question that makes sense in one country may be interpreted differently elsewhere.

Even small differences in wording can affect how participants understand instructions or respond to an assessment.

Our professional translators consider:

  • Medical and scientific terminology
  • The intended meaning of individual concepts
  • Differences in healthcare terminology between countries
  • Cultural and linguistic appropriateness
  • Patient-friendly language and readability
  • Consistency across questionnaires and study materials
  • The intended use of the translated document

We believe that human judgement, specialist knowledge and the willingness to ask questions remain essential to high-quality clinical research translation. If something is ambiguous, we don’t simply guess. We ask.

Supporting universities and research teams

Alongside our work with commercial organisations, Atlas has extensive experience supporting university research departments. We understand that academic research projects can involve complex terminology, international collaboration, specialist questionnaires and demanding timescales.

We work with researchers and university departments on projects involving medical, scientific, clinical and patient-facing materials. Whether you are preparing multilingual participant information, translating research questionnaires or supporting an international study, our team can help you identify an appropriate translation approach.

We can also advise on practical considerations such as document preparation, terminology, version control and budgeting.

Translation quality, confidentiality and compliance

Clinical research documents frequently contain sensitive, confidential or commercially valuable information. Our approach combines specialist linguist selection, established project management procedures and quality assurance processes.

Atlas Translations is certified to:

  • ISO 17100:2015 – Translation services requirements
  • ISO 9001:2015 – Quality management systems

We also hold Cyber Essentials certification.

Our project managers coordinate each stage of the translation process, including linguist selection, instructions, queries, reviews and delivery. We understand the importance of confidentiality, controlled access to project materials and careful handling of sensitive information. Our team can discuss any additional confidentiality or project-specific requirements before work begins.

More than translation

Clinical research projects don’t always fit neatly into a standard translation brief. You may need several languages, multiple review stages, input from different stakeholders or assistance with an unfamiliar linguistic validation process.

We can help you work out what is required, coordinate the linguistic elements and provide a clear, itemised quotation.

Our services also include:

We work with professional linguists across a wide range of languages, selecting the expertise appropriate to each project.

Why choose Atlas Translations?

Experience since 1991

More than three decades of supporting organisations with specialist, technical and scientific language requirements.

Human-first translation

We work with experienced professional linguists and value their specialist judgement, particularly where meaning and patient understanding are critical.

Dedicated project managers

A knowledgeable team to coordinate the work, answer questions and keep projects moving.

Established quality processes

ISO-certified procedures, appropriate review stages and attention to consistency and detail.

University and research experience

Extensive experience working with university research departments and specialist research projects.

Practical, straightforward advice

We’ll help you understand the translation and linguistic validation services you need, without recommending unnecessary stages or costs.

Get started with a quote

Satisfied clients

NHS Confederation and our healthcare translation services

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Why trust Atlas Translations?

ISO certified

Member of

35+ years of experience. Specialist expertise. Always human.

Read more about our commitment to quality

“We have worked with Atlas for a number of years now across a variety of pharmaceutical projects. Great to deal with, super quick to respond, and we have never been disappointed with the quality.”

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Frequently asked questions

Clinical trial translation involves translating documents and communications used in clinical research. These may include trial protocols, participant information sheets, informed consent forms, questionnaires, patient diaries and study reports.

The translation must reflect the intended meaning of the original while remaining appropriate for its target audience and language.

Linguistic validation is a structured process used to help establish conceptual equivalence between an original assessment and translated versions. It is particularly relevant to Clinical Outcome Assessments (COAs) and patient-reported outcome measures used in international clinical research.

Depending on the methodology, it can involve forward translation, reconciliation, back translation, review, cognitive debriefing and finalisation.

Yes. We provide forward translation, back translation and reconciliation as part of our specialist clinical research language services. Back translation is typically undertaken independently of the original forward translation to help identify differences in meaning.

Atlas does not directly conduct cognitive debriefing interviews with patients.

Where cognitive debriefing forms part of the required linguistic validation methodology, this stage can be undertaken by your research team or another specialist provider. We can support the translation and linguistic review stages associated with the process.

Yes. We support the translation of patient-reported outcome measures and other clinical research questionnaires.

The appropriate translation and validation process will depend on the instrument, its intended use and any requirements set by the instrument owner or study sponsor.

Yes, our specialist translation services are suitable for clinical research organisations, pharmaceutical companies, research sponsors and academic research teams. We can support individual documents as well as larger multilingual projects involving multiple review stages.

Yes. We translate informed consent forms, participant information sheets and other patient-facing clinical trial documentation. Particular attention is given to clarity, accuracy, appropriate terminology and the needs of the intended audience.

Yes. We support multilingual translation projects, coordinating specialist linguists across different languages and managing consistency between versions. We can also discuss terminology management and project-specific review requirements.

We use established project management and quality assurance procedures, work with professional linguists subject to confidentiality obligations and handle client materials in accordance with our information security arrangements.

We can discuss additional confidentiality requirements, including non-disclosure agreements, before a project begins.

Costs depend on the languages, word count, subject matter, complexity, timescales and the stages required. A straightforward document translation will have different requirements from a structured linguistic validation project involving multiple translations and review rounds.

We provide detailed quotations so you can see exactly what is included.

Let's talk about your clinical research project

Whether you need clinical trial documentation translated into several languages, support with a COA linguistic validation project or advice on the most appropriate translation process, we're here to help. Tell us about your project, your target languages, your timescales and any specific requirements. We'll ask the right questions, explain the options and provide a clear quotation.

Call us on 01727 812 725

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