Category 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 o