Methodologies We Employ

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As the demand for life science products increases in markets where English is not the primary language, the need for life science companies to invest in high-quality, culturally sensitive translation and localization is imperative for product and business success. In the life sciences, translation quality is vital, since even the smallest translation error can endanger patient lives. However, translation solutions required in the life sciences can vary widely, from highly technical CTD/eCTD submissions requiring fast submission times to medico-marketing materials for patient engagement. Regardless of your project, CSOFT’s customized communication solutions follow the high quality standards, such as the LISA QA method, SAE J2450 translation quality metric, glossary and style guides, and more to ensure that your translation needs are completed with the highest level of accuracy with a quick turnaround time for best return on ROI.

LISA Quality Assurance Method

The Localization Industry Standard Association (LISA) quality assurance method is used to ensure that the translated material closely aligns with client expectations for translation quality and accuracy. In the LISA method, terminology, grammar, and formatting errors are counted and rated as either Minor, Major, or Critical. Minor errors count for 1 point, Major errors count for 5 points, and Critical errors count for 1 point more than the total number of possible error points on a project, which is calculated by the total number of words translated. If a Critical error occurs, the translation automatically fails. By using the LISA method in the quality assurance process, CSOFT can apply a standardized model to ensure whether or not our clients’ projects are translated with the highest degree of accuracy and exceeds our clients’ expectations.

SAE J2450 Translation Quality Metric

The SAE J2540 translation quality translation metric is a commonly used system for quality assurance in the translation and localization industry. In order to assess the quality of a translation, the SAE J2450 metric has seven error categories: miscellaneous error (ME), misspelling (SP), punctuation error (PE),  word structure (WS), wrong term (WT), omission (OM) and addition (AD), and syntactic errors (SE). Errors within each category are categorized as either serious or minor. Serious errors are worth more points, and minor errors are worth less points, with higher scores meaning that a translation is low-quality. One of SAE J2450’s strengths is that it can be customized to suit client preferences. With the SAE J2450 metric, CSOFT can give clients the highest-quality translations that reflect their preferences.

Translation Management Systems (TMS)

Translation management systems (TMS) are used to oversee global content during the translation and localization process, such as applying reusable content during translation  and sharing linguistic data. By using a translation software to oversee workflows, automate translation processes, and centralize linguistic assets, clients can increase productivity, and save money. CSOFT’s internal TMS, ÜbrTà, enables CSOFT the ability to give clients maximum transparency and efficiency through automated, flexible workflows, intelligent resource management, and real-time progress insights.

Learn more about ÜbrTà

Glossary and Style Guides

Terminology glossaries are databases that hold an organization’s terminology and how they should be translated from English into the target language,, helping translators use all terms consistently and correctly. Likewise, a translation style guide contains rules about writing styles, sentence structure, spelling, and word usage to be consistent both visually and in writing. In the life sciences, consistency in translation is crucial, since the smallest error can result in potential death for patients. CSOFT uses terminology glossaries and style guides to ensure that clients receive the highest-quality translations that are consistent every time.

Post Layout Linguistic Proofreading (PLLP)  

In post layout linguistic proofreading (PLLP), translators review the final product’s layout to ensure that it is free of grammar, spelling, and contextual errors. This is essential, since publishers sometimes lack the linguistic ability to catch any additional errors before the product is finalized. With PLLP, CSOFT can give clients the peace of mind that their product is error-free even after the translation process is complete, avoiding inaccuracies that could result in accidental death or delay regulatory approval.

certified translations are just one of our methodologies we can employ wherever needed

ISO Certification

High-quality translation is extremely important in in the life sciences sector– inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. That is why CSOFT is dedicated to ensuring the highest-quality translation and interpretation solutions for every step in the drug development and marketing process for life science companies. To further ensure the highest-quality technical translation solutions for the pharmaceutical industry, CSOFT’s proven expertise is backed by our ISO 9001:2015 and ISO 13485:2016 certified quality management system.

Quality Assurance

In the life science, quality assurance is vital since the smallest error could result in accidental death. Because quality assurance is vital in the life sciences, life science documents such as Phase 0-IV clinical trial documentation, IEB/IRB correspondence, and toxicology reports must undergo more stringent quality assurance processes than other types of documents. CSOFT offers a variety of quality assurance steps such as  linguistic validation, back translation , In-Country Review (ICR), and linguistic testing to ensure that our clients receive the highest-quality translations.

Learn more about our quality assurance process.

Our methodologies ensure total validation