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.
As an ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 certified company, with operations leveraging best practices of ISO 27001, CSOFT’s translation process includes in-country reviewers, utilizing either new or established style guides, and subject matter expert (SME) linguists with a minimum of 7 years of experience. With over 20 years of industry experience, we have developed mature processes for translation, editing, proofreading (TEP), as well as project management.
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Through our innovative cloud-based technology, CSOFT offers an online translation management ecosystem for one central location to leverage both translation memory as well as terminology management in real time.
Professional, high-quality localization of a health service or medical product is critical for medical translation solutions entering global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects to remain in one centralized location, updated in real time, to ensure that every step of the way, CSOFT has you covered. Additionally, we are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, and our operations leverage best practices of ISO 27001 to ensure our customized solutions meet global regulatory requirements.
Learn more about our quality assurance process.