CSOFT Medical Translation Services Include:
Clinical Trials and Regulatory Submissions
Publications and Conferences
- Phase I-IV clinical protocol including synopses
- Investigator’s brochure
- ICH GCP compliant Clinical Study Report(CSR) and amendments
- 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)
- Healthcare professionals/patient education materials
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 the client needs, followed by assembling a team of writers relating to therapeutic field, regulatory knowledge, content type, and style guide as specifically required for the project.
We always ensure that senior writers play a key role in supervising the whole writing cycle, performing quality control review, assessing final deliverables and keeping in close communications with our clients through each step of project to understand their feedback and their have feedback reflected in timely manner.