Medical Writing

CSOFT’s medical writing team works closely with pharmaceutical industry professionals. We strive to develop documentation that are data based and accuracy-driven.

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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)
  • 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 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.

Contact us for more information

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xxx@csoftintl.com

devices

+1 (888)888-8888

CONTACT US

info@medl10n.com

+1-415-889-8989

US Headquarters

580 California Street, Suite 1330
San Francisco, CA 94104

Asia Headquarters

World Financial Centre, 15F
No.1 East Third Ring Road
Beijing, China 100020

Europe Headquarters

Neumannstraße 10
40235 Düsseldorf

 

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