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Drug Trial Protocol Translations

CSOFT Health Sciences offers drug trial protocol translations to enable global success in pharmaceutical markets

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Home 9 Drug Trial Protocol Translations

As the pharmaceuticals industry continues to expand internationally and more clinical trials are conducted overseas, ensuring that all trial procedures adhere to regional 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 of 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:

Learn more about our full translation coverage for the pharmaceuticals industry.

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.

Back Translation and Terminology Management

Development Safety Update Report Translations (DSUR)

With worldwide expansion of drugs in global clinical trials, development safety update report translations (DSUR) are required to address safety information of drugs. Inaccurate translations can have consequences that may compromise safe use of drugs. Whether you are a patient, clinical research organization, health organization, or a pharmaceutical company, development safety update reports are ensured to comply to global regulatory standards. With an extensive network of professional in-country linguists and subject matter experts, we have the resources and experience to help successfully translate development safety update reports. From clinical studies to patient-provider interactions, CSOFT’s translation and interpreting support in over 250 languages provides high-quality customized medical translation and localization solutions for development safety update reports.

Learn more about our development safety update report translations.

Clinical Study Report Translations

As new medical treatments continue to expand in global markets, clinical study report translations are required to analyze the methods and outcomes of clinical studies. As clinical research organizations continue to release applications for new medical treatments to access foreign markets, complying to global regulatory standards is needed to ensure credibility. With a global team of in-country linguists and subject matter experts, CSOFT Health Sciences provides high-quality customized medical translation and localization solutions for clinical study reports. From outcome analysis to medication evaluations, CSOFT’s translation and interpreting support in over 250 languages enables growing healthcare and research organizations to deliver clinical study report solutions across language barriers.

Learn more about our trial close-out report translations.

Data Security

With over 20 years of experience in medical translation, CSOFT Health Sciences understands the importance of data security to our clients, and we take nothing for granted when confidentiality is a concern. Our well-documented and fully traceable information data security policies, checklists, and quality records leverage the best practices of ISO 27001. They are designed to protect everything from source data to translations. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be sure that your project data is safe from start to finish.

Learn more about how CSOFT prioritizes data security.

Quality Assurance

CSOFT Health Sciences has developed a process for quality assurance to ensure that every medical translation project meets quality standards in a cost-effective and timely manner. We are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016 to ensure our customized solutions meet global regulatory requirements. Our subject matter expert linguists have at least seven years of experience and work with in-country reviewers and project style guides to meet industry standards.  CSOFT offers an online translation management ecosystem for one central location to leverage real-time translation memory and terminology management through our innovative cloud-based technology. Every step of the way, CSOFT has you covered.

Learn more about our quality assurance process.


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