Contract Research Organization (CRO)

We provide the highest-quality CRO translations throughout the entire drug development process

Like the projects managed by CROs, the complexity of CRO translations is astounding, not only because of the lifesaving drug therapies that are developed, but also because of the many stakeholders involved in any project – sponsors, physicians, patients, scientists, ethics committees, regulatory agencies, country affiliates, and many others. 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 critical for success. With so many moving parts and variables, professional and high-quality translation that is both cost-effective and fast is imperative for the drug development process and stakeholders involved.

CSOFT Health Sciences appreciates the demand and pressure to do things right the first time around. As a global company, with over 10,000 linguists and subject matter experts, we understand managing complexities and working with a network of highly skilled professionals to deliver projects on time and on budget. Regardless if you need translation solutions for clinical trials, adaptive trials, eClinical solutions, evidence-based trials, or emerging market trials, CSOFT has you covered. 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 has the resources and tools to provide the highest-quality translation solutions for CROs globally.

CRO Translations: 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. That is why CSOFT utilizes our AI 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.

Quality Assurance

High-quality translation is extremely important in the life sciences – inaccurate translation along the way can not only result in wasted time, money, and effort, but also affect patients’ lives. That is why CSOFT is dedicated to ensuring the highest-quality translation and interpretation solutions for every step in the R&D and marketing process for life science companies. In order to do so, we use in-country linguists with a minimum of 7 years of experience, combined with our extensive network of subject matter experts. In addition, we have perfected our localization best practices through back translation and terminology management to help you reach patients globally, in over 250 languages. To further ensure the highest-quality technical translation solutions for the life sciences industry, CSOFT’s proven expertise is backed by our ISO 9001:2015 and ISO 13485:2016 certified quality management system.

Learn more about our quality assurance process.

CRO Translations: Linguistic Validation

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, forward translation, linguistic hominization, back translation, and language reconciliation by professional life science linguists and subject matter experts such as doctors and clinicians. Here at CSOFT, we have the tools, knowledge and experience to deliver 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:

  • Summary Reports
    • Clinical Summaries
  • Case Report Forms (CRFs)
  • Clinician-Reported Outcomes (ClinRO)
No matter which therapeutic area you might be managing for your client, CSOFT Health Sciences will be there with you to ensure success. We specialize in language support for fields from Oncology and Neurology to Dermatology and Dentistry.

Learn more about out linguistic validation services.

Data Security

CSOFT has meticulously documented and fully traceable information security policies, checklists, and quality records. We understand the importance of security to our clients, which is why we take the upmost care in protecting patients’ confidentiality, as well as businesses’ data. All our data and security processes are compliant with ISO standards 13485:2016 and ISO 9001:2015. We are also compliant with ISO 17100 and leverage best practices from ISO 27001.

Learn more about how CSOFT protects your data.

With CSOFT Health Sciences, you can be confident that your client will be happy and that we will deliver you peace of mind.