CSOFT Medical Translation Services Include:
Clinical Trials and Regulatory Submissions
Publications and Conferences
- Phase I-IV clinical protocol including synopses
- Investigator’s brochure
- Clinical and non clinical summaries/reports with full compliance with ICH E3 and CTD structure
- Case narratives
- Patient information sheets and ICFs (multilingual available and subject to in-country reviews)
- ICH GCP compliant Clinical Study Report(CSR) and amendments
- Manuscripts
- Abstracts
- Posters
- Slides
- Healthcare professionals/Patient education materials
Our Methodology
CSOFT provides medical writing solutions adaptive to the specific purposes of performing clinical studies, submitting to regulatory bodies for approval or exhibiting at industry conferences.
Our carefully designed approach always starts with a Senior Project Leader analyzing our client needs. We then assemble a team of writers relating to therapeutic field, regulatory knowledge, content type, and style guide as required for the specific project.
We always ensure that our Senior Writers play a key role in supervising the entire writing cycle, as they are consistently performing quality control review, assessing final deliverables, and keeping in close communication with our clients through each step of the project to understand their feedback and ensure it is completed in a timely manner.
