French translation: Résumés intégrant l'innocuité et l'efficacité
Login or register (free and only takes a few minutes) to participate in this question.
You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.
12:23 Nov 10, 2008
English to French translations [PRO] Medical - Medical: Pharmaceuticals
English term or phrase:integrated CSS/CSE summaries
Biostatistics and Statistical programming services involve clinical trial use of Statisticians and Statistical Programmers in the development and production of:
- protocols (that includes statistical designs of trials),
- support of clinical trial set-up (feasibility, randomization, crf review),
- support of clinical trial monitoring (DMC/DSMB, Safety reports, enrollment analysis, event analysis, site fraud, Operational and Risk management plans),
- support of Clinical Study Report (Statistical Analysis plans, Statistical programming, Senior Statistical review) and
- submissions (CDISC, Transport files, ***integrated CSS/CSE summaries***, Regulatory support, post-submission rapid response, advisory committees)
- Supporting above activities on entire compounds through the use of outsourcing to low-cost regions.