Who We Are
CSOFT Health Sciences, leaders in clinical trial localization, provides AI/ML-enabled medical translation services for all phases of the drug and medical device product lifecycle, from development to post-launch. We also specialize in eCOA documentation including linguistic validation and are capable of supporting CTD/eCTD submissions with the FDA, EMA, and NMPA. Our language and technology supported solutions help to improve patient diversity in clinical trials. Our operations are certified in ISO 17100:2015, ISO 9001:2015, and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of MMA, NDA, CTA, and Medical Device Application submissions.
Industries We Serve
We are dedicated to industry-standard knowledge and quality
Helping You Globalize the Right Way
CSOFT’s experienced and dedicated global regulatory submission specialists help companies comply with these demanding multilingual documentation requirements for submissions while providing the highest linguistic quality
We can help you attain the appropriate, accurate, and sustainable compliance required throughout the entire submission process. We ensure our clients receive the necessary certifications to successfully enter emerging markets.
Medical Translation with a Focus on Precision
Our translation solutions are intended for document types relating to every stage of product development life cycle.
Quality in translation is extremely important, but within the life sciences industry, incorrect translations could literally be life threatening. We use industry-standard processes, however, we also offer flexibility for each customer to allow for their companies’ success, no matter the process.
The Knowledge Vault
Stay in the know
For many years, CSOFT has been supporting the life science industries as they continue to grow. We are dedicated to providing the highest-quality services to our clients, while making sure they have access to different policies and up-to-date information. As a medical communications company, we are taking the initiative to promote and increase awareness in the science community and to every individual.
New Publication Validates Performance of Natera’s Signatera™ MRD Test in Ovarian Cancer
Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, announced the publication of a manuscript in Gynecologic Oncology, found here, validating the performance of its personalized molecular residual disease (MRD) test, Signatera, in epithelial ovarian...
ONWARD Announces Topline Results from the LIFT Home Study Supporting Safety and Feasibility of ARC-EX Therapy to Treat People with Spinal Cord Injury at Home
ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury (SCI), reported topline results from the LIFT Home study, evaluating the safety and...
Connect Biopharma Reports CBP-201 Achieved All Primary and Key Secondary Endpoints in Pivotal Atopic Dermatitis (AD) Trial in China
Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, announced topline results for the primary analysis population of...