MedDev, Pharma, Clinical Translations

Balancing the triangle of accuracy, confidentiality and timely delivery in the Life Sciences & Healthcare

Life Science Translations by Subject Matter Experts

When the safety of a patient depends on the understanding of directions and the correct operation of medical devices, translation requires precision and up-to-date technical knowledge. Whether you are localizing medical device documentation, translating patient data or preparing clinical research related materials, our Life Sciences Localization team produces high quality and accurate medical translations that ensure patients’ safety is not put at risk.

Because of the highly technical, sensitive and regulated nature of medical texts, Commit Global fully understands the need for

  • accuracy
  • confidentiality
  • timely delivery
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and responds by:

  • selecting only professional native medical translators supported by subject-matter experts who provide real-time consulting per specific medical field
  • using the ISO 13485 quality management system in our translation process to prevent misuse and ensure that your medical devices are safe for their intended purpose.
  • implementing ISO 27001 certified processes to safeguard your sensitive and confidential information
  • working on a “follow the sun” model, having established teams across continents who respond during your time zone and ensure project workflow runs smoothly across time zones without compromising quality

We can help you with:

  • Medical Devices Translations
  • Medical Supplies & Disposables Translations
  • In Vitro Diagnostics Translations
  • Implantable Devices/Implant Translations
  • Pharma Translations
  • Clinical Trials Translations
  • Healthcare Translations
  • Health/Fitness Translations

The importance of accuracy in medical translation

Grammatical errors and inaccurate translations can jeopardize any company’s image and reputation, but when it comes to the medical industry, where inaccuracy may have direct effect on patients’ lives, quality and accuracy are not just important, they are imperative.

Medical translation is defined as the translation of technical, regulatory, clinical or marketing documentation, software or training curriculum for the pharmaceutical, medical device or healthcare fields. Most countries in the world require that documents and labelling associated with medical devices or pharmaceuticals be translated into the country’s national language to ensure the safety of the patients using them. You see, when the safety of a patient depends on the understanding of directions, clear communication and the correct operation of medical devices, there is no room for errors and misunderstandings.

What skills should a medical translator have? 

Because of this highly technical, sensitive and regulated nature of medical texts, there has been a need for translators and interpreters who not only have linguistic skills but are subject-matter experts in a specific medical field. These medical translators meet the industry’s strict scientific and linguistic criteria and produce translated content to guarantee that medical device software, site and patient documentation, and marketing texts will be understood without errors by all users, patients and physicians. The use of non-professional and non-expert translators could have particularly dire consequences on multiple levels: it could negatively impact the corporate image of a company, it could result in the clinical trial failure of a drug or a vaccine or in worst cases, it could put a patient’s well-being at risk.

It is imperative that the medical translations are as precise as possible so that the patient receives the proper care. In each medical translation project, linguists should make sure that:

  • they fully understand the source text and the medical terminology used
  • all instructions and directions are communicated correctly
  • all content is properly localized to the target language and culture

because when it comes to medical translations and human safety, one single word can make a great difference.

Linguistic validation services in the Life Sciences localization industry

 

Processes that provide an additional safety net for clients in the clinical and pharmaceutical industry

Among the multiple specialized localization services available in the Life Sciences sector we also come across those referred to as Cognitive debriefing, Back Translation & Reconciliation and Readability testing.  What does each method mean, why is it required and what does it entail?

Translation errors can change the meaning of important content in clinical trial settings resulting in medical complications or the rejection of an entire clinical research project. Ambiguity in translated health questionnaires or instruments can mean that items or questions can be interpreted in more than one way, jeopardizing patient safety and clinical trial data integrity. Unclear and hard to use translated drug leaflets mean that users may not be able to take safe and accurate decisions about their medicines.

In order to help avoid such hazards, IRBs, medical ethical committees, regulatory authorities and applicable legislation require that validation methods in accordance with FDA and ISPOR guidelines are put in place for translated documentation, such as Patient Reported Outcomes (PROs), Clinician Reported Outcomes (ClinROs), Quality of Life (QOL) questionnaires and package leaflets (PL) of medicinal products.

Cognitive debriefing (also known as pilot testing) is a qualitative method for assessing respondents’ interpretation of an assessment, using a small sample of patients. It helps determine if the respondents understand the questionnaire the same as the original would be understood and tests the level of comprehension of a medical translation by the target audience. The goal is to ensure that data collected from PROs can be comparable across various language groups used during trials. Steps of the process include:

  • Developing a debriefing protocol tailored to the target questionnaires/instruments, subject pool, mode of administration, anticipated problem items etc.
  • Recruiting respondents including in-country professionals experienced in interviewing techniques and patients that match the target population.
  • Conducting the interview (in person or otherwise) during which respondents complete the questionnaire/instrument and answer questions to explain their understanding of each question or item.
  • Generating a report with demographic and medical details of the interviewees, a detailed account of patients’ understanding of all items, including information about the number of subjects interviewed, their age, time for completing the task and any difficulties that came up.
  • Review and finalization during which a project manager checks the report’s completeness, and ensures that the detected problems are addressed by making revisions as needed for clear, precise and well understood final medical translations.
  • Creation of summary report where the service provider details the methodology used, as well as the results of the cognitive debriefing.
Back translation and reconciliation is a very effective and stringent process that provides additional quality and accuracy assurance for sensitive content, such as Informed Consent Forms (ICFs), questionnaires, surveys and PROs used in clinical trials. It is a process for checking the faithfulness of the target text against the source, focusing mainly on the conceptual and cultural equivalence and less on the linguistic equivalence.
 
In a back translation, the translated content (forward translation) is translated back into the original language by a separate independent translator. The back translator must be a native speaker of the source language and have excellent command of the target language. He/She should stick more closely to the source that he/she would for a regular translation to accurately reflect the forward translator’s choices, without attempting to explain or clarify confusing statements or to produce a “polished” output.

The next step, “reconciliation”, refers to the process of noting any differences in meaning between the two source versions. The original text is compared to the back translated text and any discrepancies are recorded in a discrepancy report.

Readability testing in the fields of pharmaceutics qualifies that the medical information contained in the drug leaflet is usable by potential users of the medication, that is, that they can understand and act upon the information provided. It is a critical step in the process of designing product literature.

Since 2005, manufacturers of medicinal products are legally required to have their patient information leaflets (PILs) readability-tested in order to acquire product approval. According to Directive 2004/27/EC, these leaflets should be “legible, clear and easy to use”, and the manufacturer has to deliver a readability test report to the authorities.

The above processes provide an additional safety net for clients in the clinical and pharmaceutical industry helping them meet regulatory requirements and allowing them to focus on their registration and marketing preparation plans.

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