MedDev, Pharma, Clinical
Balancing the triangle of accuracy, confidentiality and timely delivery in the Life Sciences & Healthcare
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 fully understands the need for
- timely delivery
and responds by:
- selecting only professional medical native-speaker translators supported by subject-matter experts who provide real-time consulting per specific medical field
- 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 Systems & Devices
- Medical Supplies & Disposables
- In Vitro Diagnostics
- Implantable Devices/Implants
The importance of accuracy in medical translations
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 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 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, Backtranslation & 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.
Backtranslation 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.
Readability testing may be carried out by the sponsor or CRO, or a language service provider undertaking the localization of the documentation. The process steps can vary, but stages may include:
- Preparation of the PL, during which the text of the leaflet is carefully edited and checked, spelling and grammatical errors are corrected, and sentences are rephrased to ensure compliance with the appropriate EMA template.
- Drafting of questionnaires with questions covering the most important details of the product and its use. These questions that must be answered correctly by any user to ensure correct use of the product.
- Pilot testing for assessing the prototype in terms of clarity, simplicity, safety, non-ambiguity, etc. Results are used to further revise the leaflet.
- Actual readability testing conducted using subjects of different ages who are native speakers of the language of the leaflet. Participants are interviewed on key questions about the product. They should be able to answer most questions correctly and no question should consistently cause problems. The goal is to achieve a 90% correctness in the responses.
- Generating reports that detail the test result based on which final edits are made.
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
The collaboration between pharmaceutical/medical device companies, CROs and translation agencies
With some of the biggest pharmaceutical/medical device companies investing up to 20% or even more of their revenues in R&D, contract research organizations (CROs) have emerged to support the industry, providing contract services for the whole spectrum of processes, from clinical research strategy and clinical trial design to regulatory submission, commercialization and post-market surveillance, and aim to reduce costs and shorten time to market.
Except for activities targeted to the domestic market, CROs also support these companies in their quest to pursue licensing approval in different countries and thus enter new markets. One of the additional tasks they undertake as part of the latter is the medical translation/localization/adaptation of the relevant documentation.
There are however companies which choose to run translation projects on their side, despite of whether they outsource other services to a CRO or not. And although having the budget to outsource may be considered an asset in some companies, other companies may own all or parts of the process, including content localization, and view this as a luxury.
Working with a Contract Research Organization (CRO)
If you are a company using a CRO for part of your development journey, and medical translation is included in this offering, good for you. You have a knowledgeable partner to support you throughout this challenging process. The same goes if you are considering to on-board one. Investing in know-how and experience, assuming you have the budget, could be a step towards faster commercialization. In this case what you may want to know about your CRO regarding the translation of your documentation is:
- What is their resourcing strategy when it comes to medical translation?
- Who owns the project management and quality assurance part, their in-house localization dept/manager, if there is one, or their partner for translation?
- What channels of communication can they set up between you and their partner for translation?
- Is there a long-term quality evaluation process and can you be involved in it, if you want to?
- What is their emergency response scenario? Remember here you need to agree on a common definition of ‘emergency’.
Working directly with a translation agency
If you are a company which prefers to own the localization stage – whether you are using a CRO for other services or not – then here are some thoughts, you might find useful:
- Decide on your translation & localization strategy; will you be using one medical translation partner for all languages? In this case, you might be looking at a higher budget which however will include a bundle of linguistic services, not only translation, but you will be saving time for your team. Will you be grouping your target languages to regions and selecting a partner for each set? In this case, you might be able to strike better deals, but besides adding management time to your team, you also need to have a sound pre-qualification and selection process and hold candidates to the same standards. This gets even more challenging when deciding to use single-language partners, though in this case the main differentiator and incentive would indeed be specialization and experience. For more detailed information on how you can select a vendor keeping to the localization strategy you have decided upon, you can download our white paper for Writing Effective RFPs for Translation and Localization Services.
- Make a list of all the document types you will need localized and determine the workflow, eg. translation, editing, back-translation, reconciliation, cognitive de-briefing, migration from paper to digital. This way you know what you are asking for and you can evaluate the proposals of potential translation partners more objectively.
- If instructions or process or product is too complex, why not schedule a live webinar for training?
- Although, it’s good to have your process set, there may be points you are uncertain of. In this case, it’s better to turn to your translation & localization partner for consult, as they may be able to share best practices from other setups and workflows they may be working on or even willing to set up a new customized process that would meet your particular needs.
While there is no right or wrong option when it comes to forming your company’s translation strategy, it is important to be aware of the variations between setups so that you can better evaluate which one best fits your given workflow, taking into account your priorities, capacities and limitations.