CSOFT Health Sciences specializes in end-to-end translation for all stages of the product development lifecycle, with high-volume document translation solutions for a variety of medical and healthcare document types including:
- CTD/eCTD submissions
- Phase 0 to IV Clinical Trial Documentation
- Toxicology Reports
- Research Protocols
- Development Safety Update Reports (DSURs)
- Informed Consent Forms
- Case Report Forms (CRFs)
- Clinical Study Reports (CSRs)
- Clinical Services Agreements
- FDA, EMA, and NMPA submissions
- Patient Information Sheets
- Adverse Drug Reactions (ADRs)
- AEs/Ars/SAEs/SUSARs (IEB/IRB Correspondences)
- Medico-marketing materials
- Package Inserts and Labels
- Medical Research Documents
Efficiently Meeting the Highest Standards Through Terminology Management
Effective terminology management is essential not only to ensuring the quality and consistency of each document, but also to expediting urgent translation needs with rapid turnaround times and reduced costs. In fact, implementing effective terminology management at the outset of a translation project can save 20% or more in total costs and reduce errors by 50%.
CSOFT’s cloud-based terminology management system (TMS), AI-powered translation memory system, and glossary management practices ensure that every document in a series is translated consistently and to the specifications for target markets, with in-country linguists helping to ensure the most up-to-date terminology across target geographic regions.
Certified Translation Services for All Medical Documents
CSOFT Health Sciences is an IS0 9001:2015 and ISO 13485:2016 certified language service provider with operations compliant with ISO 17100, ensuring our medical document translation services meet the highest standards for quality assurance. Our translation best practices include the use of in-country reviewers and subject matter experts specific to each project we undertake, with linguists holding a minimum of 7 years’ in-field experience. Each document that we deliver undergoes thorough translation, editing, and proofreading (TEP), with linguistic validation and additional services as required to meet the rigorous requirements or regulatory submissions, patient information, and medical product documentation.
Good Documentation Practices (GDP) Translations
Good Documentation Practices (GDP), also referred to as GDocP, describes a set of standards that are designed for the pharmaceutical and medical device industries and required by most regulatory bodies including the FDA, EMA, TGA, and more. These procedures are typically carried out electronically, and mandates for life science companies to keep a variety of documented records throughout the product’s lifecycle. High quality medical translation of these documents is essential for international regulatory compliance.
Learn more about our Good Documentation Practices (GDP) Translations.
Data Security
We have well-documented and fully traceable information security policies, checklists, and quality records. CSOFT understands the importance of security to our clients and we take nothing for granted when confidentiality is a concern. All our data and security processes comply with our certified 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 our data security.