Contract Research Organization (CRO) Translations
We provide the highest-quality CRO translations to support agile clinical trial management throughout the entire drug and medical product development process
Global CRO Translations: Improving Access to Health Research Across Language Barriers
Contract Research Organizations (CROs) encounter significant challenges in managing translation needs for drug development projects. The intricacy arises not only from the global regulation and development of life-saving drug therapies but also due to the involvement of diverse stakeholders such as sponsors, physicians, patients, scientists, ethics committees, regulatory agencies, and country affiliates. This complexity exposes CROs to potential setbacks stemming from poor quality or inadequate localization. Quality translation is crucial for CROs to navigate through the complexities of communication accurately. The consequences of subpar translation range from costly delays to severe setbacks. CROs play a vital role in modern preclinical and clinical research, and effective translation of a wide range of materials is indispensable for meeting global mandates and conducting flexible clinical trials across languages. Given the rising trend of conducting clinical trials outside the US and Europe, accurate translation and interpretation become even more critical for initial start-up success and agile trial design. The drug development process is financially demanding, making it imperative to have professional, high-quality, cost-effective, and fast translation services for effective collaboration among stakeholders.
CSOFT Health Sciences understands the demand and pressure faced by CROs to get things right from the start. As a global company, we recognize the challenges of managing complexities and collaborating with a network of skilled professionals to deliver projects within deadlines and budgets. Whether it’s translation solutions for pivotal clinical trials, adaptive trials, eClinical solutions, evidence-based trials, or emerging market trials, CSOFT Health Sciences serves as your trusted language intelligence partner. Utilizing our advanced AI translation technology, quality assurance process, including linguistic validation, data security, and privacy protection, as well as our network of over 10,000 subject matter experts and linguists, CSOFT Health Sciences is designed to provide the highest-quality translation solutions for CROs globally in 250+ languages.
End-to-End Clinical Trial Translations
Whether entrusted to CROs or conducted in-house, clinical trials account for an enormous portion of the investment required to bring drug therapies, medical devices, and other innovative medical treatments to market in any country, making clinical trial translation solutions necessary when conducting trials across languages. For pharmaceutical and medical device companies expanding in overseas markets, access to clinical trial translations is crucial to meet local regulatory requirements. Inaccurate translation of clinical trial materials risks regulatory viability in the target market, as well as potentially endangers patient safety and drug efficacy, making precise, high-quality translation an essential priority for all stakeholders involved.
CSOFT Health Sciences’ clinical trial translation specialists enable clear, cost-effective, and consistent translations for all document types, including:
CRO Translations with Our Advanced Translation Technology
Technology is crucial to the modern translation and localization process. From the minute the source content is authored, validated, and prepared for translation to when translated content is reviewed and deployed for worldwide distribution, you can be certain that we leverage the best translation technology. CSOFT Health Sciences utilizes advanced translation technology through translation memory (TM), machine translation (MT), translation management system (TMS), and content management system (CMS) to ensure fast, high-quality translation for the best ROI.
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Clinical Trial Protocol Translations
Clinical trial protocol translations enable sponsors and CROs to comply with global regulatory standards and communicate the objectives of a clinical trial in different languages. Clinical trial protocols are crucial documents that aim to describe the objective, study design, safety measures, organization, and other important aspects of how the trial will be conducted. For anyone conducting clinical trials overseas and in compliance with global regulatory standards, translations for clinical trial protocols might be required for approval. With a global network of linguists and subject matter experts, CSOFT Health Sciences provides accurate and cost-effective translations for clinical trial protocols on a global basis.
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Linguistic Validation for CRO Translations
Part of ensuring the quality of CRO translations for the life sciences is the process known as linguistic validation. Linguistic validation is a complicated undertaking involving medical terminology management in document preparation, forward translation, reconciliation, back translation, and harmonization by professional life science linguists and subject matter experts such as doctors and clinicians. Here at CSOFT Health Sciences, we have the tools, knowledge, and experience to deliver the top-notch linguistic validation services our clients depend on for global success. We provide linguistic validation services for a variety of different life science technical documentation, including:
No matter which therapeutic area you might be managing for your client, CSOFT Health Sciences will be there with you to ensure success in 250+ languages.
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Full Translation Coverage for A Range of Therapeutic Areas
CSOFT Health Sciences’ medical translation and localization coverage extends across a full range of clients, therapeutic areas, and treatment settings. Whether you are a hospital looking for medical communication support in a related area, such as cardiology translations, autoimmune disease translations, oncology translations, neurology translations, dermatology translations, and dentistry translations, or a research organization recruiting patients for clinical trials, CSOFT’s end-to-end localization support covers an extensive range of conditions and therapies across disciplines.
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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 7 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 translation memory and terminology management in real time through our innovative cloud-based technology. 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 the best practices of ISO 27001 and 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.