Artificial intelligence (AI) and machine learning have become increasingly more prominent in the life sciences. From sequencing genomes for new drug therapies and providing earlier and more accurate diagnoses for patients through improved personalized care, to broader and protected data sharing of electronic health records (EHRs) and shortening of clinical trial times, the utility of AI in the life sciences is evident. As technology continues to advance, life science companies expanding into global markets require quick translation to improve patients’ lives around the world.
CSOFT provides the highest-quality translation solutions for life science companies. With our advanced language technology, combined with our extensive network of linguists and subject matter experts, we harness the ability to effectively translate AI and machine learning platforms, including data management systems for patients and clinical trials, innovative predictive models, and advanced medical device technology in over 250 languages.
Software as a Medical Device (SaMD) Translation
The International Medical Device Regulators (IMDRF) defines SaMD as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” With the increasing availability of digital platforms, as well as the accessibility of cloud platforms, SaMD is quickly gaining momentum and growing within the healthcare industry. This rapid development has led to an increased demand for translation of these products. In order to comply with global regulatory policies, high-quality translation of these devices is crucial in both ensuring international market success, as well as improving patient lives.
With medical device industry experts, combined with our extensive experience in localizing software around the world, CSOFT offers the highest-quality, cost-effective translation solutions for SaMDs. Our professional linguist team is well versed in local cultural nuances and work with software engineers and medical device companies to localize UI strings, linguistic, functional, and cosmetic testing, as well as user assistance and documentation translations to guarantee a quick turnaround time for any project, any time of the year.
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Regulatory compliance is crucial for life science companies expanding into international markets. The rigorous requirements regulatory bodies require around the world differ depending on region, product, and application in terms of patient health and safety. To increase clinical trial transparency, as well as to speed up regulatory submission timelines, AI and machine learning are playing an increasingly important role in providing highly accurate modifications dependent on local regulatory requirements in terms of redaction or anonymization. In addition, AI and machine learning can improve predicted regulatory submission timelines, since the tools take into account specific data points that impact regulatory approval.
CSOFT, as a professional and certified language service provider, has the experience and expertise to help life science companies expanding into global markets gain regulatory approval quickly. Through our team of in-country linguists and subject matter experts (SMEs) , we are able to quickly and accurately localize regulatory submission documents like CTD/eCTDs and electronic health records (EHRs) that harness automated technology through AI and machine learning.
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High-quality translation is extremely important in the life sciences – 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 R&D and marketing process for life science companies. In order to do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts. In addition, we have perfected our localization best practices through linguistic validation, back translation, and terminology management to help you reach patients globally, in over 250 languages.
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Advanced Language Technology
Just as AI and machine learning are critical for life sciences, localization also requires modern technology solutions to ensure the highest-quality for the best ROI. CSOFT harnesses our advanced language technology to improve glossaries, maintain terminology management, and automate continuous translation for large projects that are continuously updated.
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Keeping data secure in the life sciences is critical in protecting patient privacy as well as innovative drug therapies for life science companies. We have well-documented and fully traceable information security policies, checklists, and quality records. CSOFT understands the importance of security to our clients and we take nothing for granted when confidentiality is a concern. All our data and security processes comply with our certified ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.
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