Solutions for Clinical Research Organization Translations: End-to-End Support for CROs
CSOFT’s clinical research organization translation services ensures the global success of clinical solutions.
With more clinical trials being outsourced in global markets, clinical research organization translations encompassing a full range or multilingual medical communications are key to enabling successful clinical trials and research, especially when needs may vary across different countries and cultures. The complexity of projects managed by CROs is astounding, particularly with respect to the many stakeholders involved in any particular project, including sponsors, physicians, patients, scientists, ethics committees, regulatory agencies, country affiliates and numerous other parties. In addition, since the drug development process is so costly, clinical trials are increasingly conducted outside of the US and Europe, making accurate translation and interpretation critical for success and safety. With so many moving parts and variables, high-quality professional translations that is both cost-effective and fast are an imperative part of the drug development process for all stakeholders involved.
As a global company with over 10,000 linguists and subject matter experts worldwide, CSOFT understands the complexities of working with a network of expert professionals to deliver projects on time and on budget. No matter which therapeutic area you might be managing for your client, from clinical trials and adaptive trials to eClinical solutions, evidence-based trials, or emerging market trials, CSOFT’s clinical research organization translations ensure your content is localized accurately and consistently in over 250 language. With our advanced AI translation technology, quality assurance process including linguistic validation, and data security and privacy protection, CSOFT has the resources and tools to provide the highest-quality translation solutions for CROs globally.
- CRF Translations
- IFU Translations
- PROsTranslations
- Patient Diaries/Reports Translations
- Investigator’s Brochure Translations
- Clinical Study Protocol Translations
- Regulatory Document Translations
- Study Paper Translations
- Labels Translations
- ICF Translations
- Package Inserts Translations
- Marketing Collateral/Brochure Translations
In addition, we specialize in high-quality language solutions for the following industry fields:
- Cardiology Translations
- Dental Translations
- Dermatology Translations
- Gastroenterology Translations
- Ophthalmology Translations
- Genetic Disease Translations
- Hematology Translations
- Infectious Disease Translations
- Obstetrics Translations
- Hepatology Translations
- Immunology Translations
- Pulmonology Translations
- Infection Translations
- Neurology Translations
- Oncology Translations
- Orthopedics Translations
- Psychiatry Translations
- Pediatrics Translations
- Psychology Translations
- Rare Disease Translations
- Autoimmune Disease Translations
- Women’s Health Translations
- Men’s Health Translations
- Geriatrics Translations
- Substance Abuse Translations
Linguistic Validation for Clinical Research Organization Translations
Part of ensuring the translation quality for the life sciences, particularly CROs, 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:
- Patient Recruitment
- Informed Consent Forms (ICFs)
- Patient-Reported Outcomes (PROs)
- Clinical Outcome Assessments (COAs)
- Regulatory Documents
- Summary Reports
- Clinical Summaries
- Case Report Forms (CRFs)
- Clinician-Reported Outcomes (ClinRO)
Learn more about out linguistic validation services.
Life Sciences Terminology Management
Effective medical device terminology management in the source document saves businesses 20% or more on translation costs. While writers and translators receive specialized training in the medical field, it still takes time to research important terminology during the content development and translation process. Studies find that the number one factor affecting translation quality is the inaccurate and inconsistent use of technical terms specific to a particular industry.
Download our white paper on Terminology Management for the Life Sciences to learn more about how CSOFT can improve your quality while reducing cost.
Quality Assurance
Professional, high-quality localization of a service or product is critical for translation solutions in global markets. CSOFT understands the importance of accurate translation, which is why we have developed a process for quality assurance to ensure that any project that is translated meets quality standards in a timely manner that is also cost effective. Our advanced translation technology management system allows for translation projects remain in one centralized location, updated in real time, to ensure CSOFT has you covered every step of the way. Additionally, we are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, ensuring our customized solutions meet global regulatory requirements and our clients’ highest expectations for quality.
Learn more about our quality assurance processes.
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 security processes leverage best practices from ISO 27001, ensuring we adhere to the latest international standards in information security.
Learn more about CSOFT’s data security procedures.
Speak to us today!
For more information on how CSOFT can assist you with your translation requirements, please contact us through this website, or call us at +1-617-263-8950.
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