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
Like the projects managed by contract research organizations (CROs), the complexity of CRO’s translation needs when bringing drugs to market is simply astounding. Not only because of the lifesaving drug therapies that are developed and regulated across borders and languages, but also because of the many stakeholders involved in any project – sponsors, physicians, patients, scientists, ethics committees, regulatory agencies, country affiliates, and many others – CROs face some of the highest exposure to the potential downsides of poor quality or inadequate localization. From costly delays to even more serious setbacks, quality translation is essential to ensuring CROs communications are accurate and viable for market.
CROs are essential to the modern-day preclinical and clinical research process, and only the medical translation of a vast array of materials enables CROs to meet global mandates and operate across languages to conduct flexible clinical trials more effectively. In addition, since the drug development process is so costly, clinical trials are increasingly being conducted outside of the US and Europe, making accurate translation and interpretation still more critical even for initial start-up success and agile trial design. With so many moving parts and variables, professional and high-quality translation that is both cost-effective and fast is imperative for the medical product and drug development process, and the stakeholders involved.
CSOFT Health Sciences appreciates the demand and pressure CROs face to do things right the first time around. As a global company, we understand managing complexities and working with a network of highly skilled professionals to deliver projects on time and within budget. Whether you need translation solutions for pivotal clinical trials, adaptive trials, eClinical solutions, evidence-based trials, or emerging market trials, CSOFT Health Sciences is your trusted language intelligence partner. Through our advanced AI translation technology, quality assurance process, including linguistic validation, data security and privacy protection, as well as 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 over 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:
Learn more about our clinical trial translations.
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.
Learn more about our advanced translation technology.
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 a crucial document that aims 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 mater experts, CSOFT Health Sciences provides accurate and cost-effective translations for clinical trials protocols on a global basis.
Learn more about our clinical trial protocol translations.
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.
Learn more about our linguistic validation services.
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.
Learn more about our comprehensive coverage for therapeutic areas.
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 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.
Learn more about our quality assurance process.
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 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.