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integrated CSS/CSE summaries

French translation: Résumés intégrant l'innocuité et l'efficacité

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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.
Yves Cromphaut
Local time: 14:59
French translation:Résumés intégrant l'innocuité et l'efficacité
Explanation:
CSS = Combined Summary of Safety
CSE = Combined Summary of Effectiveness
Selected response from:

Hélène ALEXIS
France
Local time: 14:59
Grading comment
Merci
4 KudoZ points were awarded for this answer

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Summary of answers provided
3Résumés intégrant l'innocuité et l'efficacité
Hélène ALEXIS


  

Answers


31 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
integrated css/cse summaries
Résumés intégrant l'innocuité et l'efficacité


Explanation:
CSS = Combined Summary of Safety
CSE = Combined Summary of Effectiveness

Hélène ALEXIS
France
Local time: 14:59
Works in field
Native speaker of: French
PRO pts in category: 12
Grading comment
Merci
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