Pharmaceuticals

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The global pharmaceutical sector is currently valued to be over a trillion-dollar industry, with predicted estimates to be even more profitable in the future. However, as regions such as APAC become more accessible to and profitable for the rest of the world, pharmaceutical companies will need to ensure that their pharmaceutical drugs are marketed with properly translated and localized medico-marketing materials. Beyond medico-marketing materials, the growing overseas demand for overseas drugs means that pharmaceutical companies need to ensure that clinical trial documentation and regulatory documents are translated with the highest degree of accuracy and quick turnaround times; not doing so not only prevents companies losing millions from failing to comply with regulations, but also potentially endangering patient lives.

CSOFT’s global network of more than 10,000  in-country linguists and subject-matter experts (SME) can provide pharmaceutical companies with end-to-end translation, localization, and transcreation  solutions for all stages of the medication lifecycle in 250+ languages, from CTD/eCTD submission and phase 0-IV to clinical trial documentation, pharmacovigilance reports and medico-marketing materials.

Medical Document Translation

All phases of the medicine development lifecycle – from regulatory documents such as CTD/eCTD submissions and new drug applications (NDA), clinical trial documentation, and pharmacovigilance – involve high document volumes that require high levels of accuracy with fast turnaround times. If such documents are not translated accurately as well as quickly, companies could fail to gain regulatory compliance, causing costly delays in the drug development lifecycle. Worse, a lack of accuracy could result in patient death. CSOFT understands these concerns, and provides pharmaceutical companies fast, high quality translations of CTD/eCTD submissions; research protocols; case report forms (CRFs); informed consent forms; FDA, EMA, and NMPA submissions; and other documents for the best ROI.

Learn more about our medical document translation services.

Multilingual Clinical Trials

Clinical trials are an essential element of the drug development process. As the demand for pharmaceutical drugs increases overseas, more and more clinical trials are conducted in countries where English is not the dominant language. In order to satisfy regulatory compliance and meet recruitment targets, using high-quality and accurately translated and localized clinical trial documentation and patient recruitment material is essential for successful clinical trials. CSOFT can provide pharmaceutical companies with extremely accurate and culturally appropriate phase 0-IV clinical trial documentation and patient recruitment material.

Learn more about our multilingual clinical trial solutions.

Pharmacovigilance

Pharmacovigilance is a branch of pharmacology that focuses on monitoring, analyzing, reporting, and preventing adverse drug reactions (ADRs). As the global pharmaceutical market shifts overseas, submitting extremely-accurate translations of common pharmacovigilance documents like adverse event (AE) and individual case study reports (ICSR) to regulatory agencies on time is critical to protecting consumers worldwide. With a large network of subject-matter experts and a global network of 10,000 in-country native linguists, CSOFT offers highly-accurate and timely multilingual translation solutions for a wide variety of pharmacovigilance needs in 250+ languages, from DSURS and discharge reports to CIOMs forms and clinical trial documents.

Learn more about our CSOFT’s pharmacovigilance translation services.

Data Security

CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are compliant with ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.

Learn more about how CSOFT protects your data.

Quality Assurance

High-quality translation is extremely important in in the pharmaceutical 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. 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 back translation and terminology management to help you reach patients globally, in over 250 languages. 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.

Learn more about our quality assurance process.