Clinical Trial Protocol Translations
CSOFT Health Sciences specializes in end-to-end clinical trial localization solutions including clinical trial protocol translations.
With the increase in global clinical trial sites, clinical trial protocol translations are essential for ensuring that the standard operating procedures and the scientific protocols of a trial can be repeated or assessed in any market, regardless of the languages spoken. Protocols for clinical trials are written to standardize the objective, study design, safety measures, organization, statistical analysis, and other key aspects of the trial in such a way that it can be successfully repeated to the same standards. Clinical trial protocols play an important role by establishing a clear and descriptive document that can be followed and assessed by a regulatory body while remaining in compliance with Good Clinical Practice (GCP) guidance. For pharmaceutical companies, biotechnology companies, medical device manufacturers, and academic research institutions, clinical trial protocol translations are a necessary step for ensuring the safety of a clinical trial and upholding the integrity of data collected during the trial.
With a global team of 10,000+ linguists and subject matter experts in end-to-end localization solutions for clinical trial documents and life science regulatory translations, CSOFT Health Sciences can support companies with translations for required protocol features, including IRB correspondence translations, Investigator’s Brochures (IBs) translations, and Informed Consent Form (ICF) translations.
Clinical Trial Translations
Clinical trial protocols can be just one of the many documents that may need to be submitted for review by an ethics committee or an institutional review board (IRB) during the early phases of a clinical trial, and as changes are made throughout the trial. With the rise in number of clinical trials being conducted in overseas markets and the development of new regulations, such as the EU-CTR, it is more important than ever to meet all the standards when it comes to clinical trial translations. Whether you will be submitting a clinical trial application (CTA) or you currently have a clinical trial underway, CSOFT Health sciences can support all your translation needs to ensure that essential documents are available in 250+ languages and in compliance with Good Clinical Practice (GCP) guidance. Even for remote clinical trial translations, our global team of certified linguists and subject matter experts have plenty of experience in phase 0-IV translations for clinical trials, and can support you in areas including:
Contract Research Organizations (CROs) are essential life sciences companies that provide support through the clinical trial process in areas including management, pharmacovigilance, product development, and other services, making CRO translations crucial to help facilitate clinical trials. As administrators, CROs play an important role of having to be fully aware of any clinical trial protocols and must be able to navigate linguistic barriers, especially during multinational clinical trials. Just as the other stakeholders involved in the trial process benefit from the expertise of CROs, CROs can benefit greatly from cost-effective and time efficient translations that help to ensure that documentation adheres to regulatory language guidelines and can be interpreted in various international settings. To support CROs in their role, CSOFT Health Sciences provides high quality localization solutions across 250+ languages.
Learn more about our CRO translations for the clinical trial process.
As with other life sciences companies involved in a clinical trial, protocols can be a crucial and required piece of documentation for biotech companies seeking to bring new technology to global markets. Ensuring that the trial participants and the data collected adheres to regulations and follows standard operating procedures (SOPs) is an important purpose for high-quality biotech translations. With the global expansion of the biotech industry, and new markets emerging throughout Europe, Asia, and South America, biotechnology translations are a necessary step to provide documentation across a range of languages and for all types of technical documents, including manuals, learning guides, and safety reports. Even more, regulatory authorities including the National Institutes of Health (NIH) and the European Medicines Agency (EMA) have strict linguistic requirements for clinical trials conducted under their guidance and in multiple countries. Biotech is a crucial industry for the discovery and development of potentially lifesaving medical technology and assisting biotech companies to reach patients globally is an important purpose for our biotechnology translations.
With a global network of 10,000+ linguists and subject matter experts in growing industries such as medical device translations, in-vitro diagnostic device (IVD) translations, and biomedical engineering translations, CSOFT Health Sciences supports the biotech industry in areas including:
Adverse Event Reporting Translations
To avoid the issue of under-reporting of adverse events and meet the time-sensitive deadlines for clinical reporting in clinical trials, adverse event reporting translations are essential for regulatory compliance and successfully bringing new products to market. During clinical trials, adverse events (AE), serious adverse events (SAE), and adverse drug reactions (ADRs) are expected to be reported to the regulating agency within specific timelines, which can be as short as 7 days as outlined under FDA regulations for investigational new devices (INDs). Within the field of pharmacovigilance, clinical monitoring for all SAEs, ADRS, and AEs is an integral process for ensuring the safety of trial subjects and proving the efficacy of new medical devices and pharmaceutical products. With an increasing number of clinical trials being conducted internationally, be able to provide multilingual adverse event reports and documents is required by many global regulators and is essential for avoiding potentially life-threatening situations. With a global network of linguists and a team of subject matter experts when it comes to pharmacovigilance processes, CSOFT Health Sciences offers fast turnaround times to meet your adverse event reporting translation needs across 250+ languages.
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The pharmaceuticals industry is a global leader when it comes to conducting clinical trials and bringing new therapies to global markets. With a growing demand for the production and deployment of pharmaceutical drug therapies in overseas markets, pharmaceutical translations are essential for a wide range of documents for the clinical trials process. Especially for documents required in the early phases of a pharmaceutical trial, to include protocols and clinical trial agreements, a timely and well-translated document can be crucial to ensuring success during future phases. Moreover, the global pharmaceutical industry has strict regulations that vary by country and meeting the language requirements can help to establish compliance with GCP guidance and protect the safety of all those involved. From translations of drug safety documentation to translations for drug product labels and instructions for use (IFU) translations, CSOFT Health Sciences offers professional localization solutions for the pharmaceutical industry and all stages of the product development cycle.
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Institutional Review Board (IRB) Correspondence Translations
As research in the health science industry continues to expand on a global scale, Institutional Review Board (IRB) correspondence translations are essential to ensure protection in rights of human subjects in clinical trials. To access foreign markets, documents including IRB protocol forms, amendment forms, and progress report forms must be translated and localized to meet international regulatory standards.
With a global team of in-country linguists and regulatory specialists, CSOFT Health Sciences can help ensure regulatory submission compliance while providing the highest-quality translation and localization solutions across 250+ languages.
Learn more about our IRB correspondence translations.
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 a minimum of 7 years’ experience and work with in-country reviewers and project style guides to meet industry standards. And 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. Every step of the way, CSOFT has you covered.
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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 best practices of ISO 27001, and are designed to keep everything from source data to translations protected. From our 24/7/365 data monitoring and advanced encryption to our access control measures, you can be certain that your project data is safe from start to finish.
Learn more about how CSOFT prioritizes data security.