As the pharmaceuticals industry continues to expand internationally and clinical trials for pharmaceutical products are increasingly conducted overseas, ensuring that all trial procedures adhere to regulatory standards demands high-quality and accurate drug trial protocol translations. Protocols for pharmaceutical products in clinical trials are designed to standardize the study’s objective, design, safety measures, organization, statistical analysis, and other key aspects, to ensure that any replication of the trial can be successful and held to the same standards. Drug trial protocols also play an important role by establishing a clear and descriptive document that can be assessed by a regulatory body while remaining in compliance with Good Clinical Practice (GCP) guidelines, and are an essential clinical document required in Trial Master Files (TMFs/eTMFs) submissions. For any pharmaceutical company conducting international clinical trials, drug trial protocol translations are a necessary step for ensuring the safety trial participants and for upholding the integrity of the data that is being collected. To facilitate success in developing new pharmaceutical products and reaching new markets, CSOFT offers high quality and cost-effective translations for drug trial protocols.
In addition to our drug trial protocol translations, our global network of linguists and subject matter experts provide a full range of Trial Master File (TMF/eTMF) translations for the pharmaceuticals industry.
Learn more about our Trial Master File (TMF/eTMF) translations.
End-to-End Translations for the Pharmaceuticals Industry
As one of the most heavily regulated industries worldwide, every stage of the pharmaceutical product’s lifecycle requires detailed documentation to ensure the product can safely be researched, developed, and brought to market. Throughout this process, international regulations for language requirements demand high quality and timely translations for all types of documents, ranging from phase 0-IV clinical trials document translations all the way to medico-marketing material translations. To help pharmaceutical companies navigate these strict guidelines and bring products to new global markets, CSOFT Health Sciences offers a full range of pharmaceutical translations in 250+ languages, including translations for:
Pharmaceuticals Regulatory Translations
As part of the development process before having a new pharmaceutical product approved, drug trial protocols a crucial piece of documentation that is required to be submitted and approved by a regulatory authority. Among the many documents that are necessary to have a new drug approved, international regulations on language requirements demand translations for approving products in different countries and for conducting international clinical trials. To help companies gain regulatory compliance, CSOFT Health Sciences offers a full range of regulatory translations for the pharmaceutical industry, including for specific standards, with Good Documentation Practices (GDP) translations and CE Marking translations.
Learn more about our regulatory translations for pharmaceuticals companies.
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 certified with ISO 13485:2016, ISO 9001:2015, and ISO 17100:2015, and leverage best practices from ISO 27001.
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High-quality translation is extremely important in the life sciences, and inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance specific to the life sciences, which includes linguistic validation, to ensure that any project meets quality standards in a timely and cost effective manner. 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 and advanced language technology. 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, CSOFT’s proven expertise is backed by our ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified quality management system.
Learn more about our quality assurance process.