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.
Theranica Achieves Positive Results in Placebo-Controlled Pivotal Trial of Nerivio® for Preventive Treatment of Migraine
Theranica Bio-electronics, a prescribed digital therapeutics company developing advanced digitally connected neuromodulation devices for migraine and other pain conditions, announced positive top-line results in its double-blind, randomized, placebo-controlled,...
Gilead, MacroGenics Unite Against Hematologic Cancers in $1.7B Biobuck Deal
Gilead Sciences and MacroGenics entered a licensing and collaboration pact worth up to $1.7 billion to develop a bispecific antibody to treat hematological cancers. This comes only two months after the latter announced staff cuts. The partnership includes three...
Clinical Trial Corner: Patient Diversity in Clinical Trials Part 2, Assessing the Proportionality of Countries’ Participation In Pharmaceutical Development Relative to Their Consumption
Clinical Trial Corner is a biweekly series from Dr. Vladimir Misik, founder of LongTaal and CSOFT’s VP of Global Clinical Strategy. In the first part of my blog of this two part series on patient diversity in industry CTs (iCTs), I summarized the importance of the...