Tag Archives: life sciences

Commit excels in Life Sciences

by Hara Samara, Project Coordinator at Commit

There is certainly a lot to be said for the importance of translation in Life Sciences and much digital ink has been spilled on the challenges involved in the field.  However, today we would like to take the opportunity to share and celebrate some amazing feedback we received from a dear client about projects we completed in 2018 for a global developer and manufacturer of clinical diagnostic products.

Our client ran quality checks on samples drawn from approximately 200 projects we completed from February 2018 to September 2018 and the results illustrate the quality of translations for biomedical laboratory instruments, in vitro diagnostics systems, chemistry data sheets and IFU documentation for haematology analysers among others.

The quality checks have been carried out in all 36 languages that the documentation is translated into and our Life Sciences team scored the amazing amount of zero errors in the sample analysed, which ranks us NUMBER ONE in terms of quality out of 36 languages in total!

Here is what makes Commit stand out:

Passion: We love localisation and this is probably our most effective trait, since our passion for what we do enhances the desire to pursue excellence and makes us motivated, creative and resourceful. As Aristotle put it “Pleasure in the job puts perfection in the work.”

Specialisation: Handling volumes that exceed 1 million words per year, Commit has established expertise in the field of Life Sciences. Our industry knowledge and proficiency are what makes us successful and highly effective even when things do not go quite as expected, i.e. more often than not!

Tools: Commit uses a range of technical solutions to meet the needs of our clients and offer quality assurance. Our commitment to the ISO 9001 and ISO 17100 standards in combination with the use of state‑of‑the‑art technology in CAT and QA tools allows us to build and maintain translation memories and termbases, ensure consistency, minimise human error and deliver top‑quality translations.

Tailored services: Be it a 200,000 words document concerning instructions for use for an immunoassay analyser or a handful of words from a chemistry data sheet, our expert project management team analyses the request and its individual specs to develop a tailored plan that allows us to handle successfully the highly‑sensitive content our clients trust us with.

Expert linguists: Last, but by no means least, at the core of our success is teamwork and the professional specialised translators we collaborate with. Being responsible for this account over the last 10 months, I am thrilled to see our efforts pay off and I would like to take this opportunity to thank all the linguists that travelled with me all the way to the first place among 36 languages and contributed in such top‑quality results. This would never have happened without your commitment, diligence, precision and attention to detail. I know it’s been a rocky road sometimes and I would like to sincerely thank each and every one of you for the excellent collaboration and support, even when things have been challenging – well, especially then!

Cheers to you and our future adventures!

Linguistic validation services in the Life Sciences localization industry

by Nicola Kotoulia, Project Coordinator at Commit

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. How familiar are you with these methods? What does each 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 (International Society for Pharmacoeconomics and Outcomes Research) 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 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. They restate in their own words what they think each translated item means. This way the interviewer discovers errors and difficulties and locates points that are confusing or misunderstood.
  • 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. It may also include investigator recommendations or solutions for resolving confusion or difficulties.
  • Review and finalization during which a project manager checks the reports completeness, and ensures that the detected problems are addressed by making revisions as needed for clear, precise and well understood final 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. Discrepancies may be due to ambiguity in the source text, errors introduced by the forward translator, or back translation errors. The reconciler flags issues such as differences in meaning, inconsistent/incorrect terminology, unsuitable register, missing/added information, ambiguities or errors in the backtranslation. Several back and forth between the linguists may be needed to reconcile the versions so that edits and adjustments are made as needed to optimize the final translation.

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 responces.
  • 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 Importance of Accuracy in Medical translations

Medicine

by Effie Salourou, Customer Operations Manager at Commit

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 understanding of directions, clear communication and the correct operation of medical devices, there is no room for errors and misunderstandings.

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, 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 life/health at risk.

To prove that, we are going to give you an example of how the wrong translation of a single word by a non-professional resulted in a medical malpractice compensation of $71 million.

Many of you might be familiar with the story of the 18-year old Willie Ramirez. Back in 1980, Willie was admitted to a Florida hospital in a comatose state. His family, who only spoke Spanish, described his condition to the paramedics as “intoxicado”. Translation was provided by a bilingual staff member who translated “intoxicado” as “intoxicated”. Among Cubans, “intoxicado” is kind of an umbrella term that means there’s something wrong with you because of something you ate or drank, a meaning closer to the term “poisoned”. A professional translator or interpreter would have known that despite the similarity of the two words, the Spanish word is NOT equivalent to the English word “intoxicated”, that implies alcohol or drug use. His family believed he was suffering from food poisoning, while he was actually suffering from an intracerebral hemorrhage. The doctors believed he was suffering from an intentional drug overdose, which can lead to some of the symptoms he displayed. Because of the delay in his treatment, Ramirez was left quadriplegic.

OK, this example might be extreme, but it shows how important it is for the translator/interpreter to fully understand medical terminology in both languages.  It is imperative that the translations are as precise as possible so that the patient receives the proper care. In each medical translation project, the linguist should make sure that:

  • he/she fully understands 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.