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- Title
Scrutinizing Non-Core Protocol Procedures.
- Authors
Getz, Kenneth A.
- Abstract
The article informs that pharmaceutical company Medidata Solutions Inc. has sponsored a research study in which several biotechnology companies participated and provided data on 10 Phase II and III protocols targeting diseases throughout multiple therapeutic areas. It informs that the companies classified each protocol procedure during the study according to the objective it supported as defined by the clinical study report (CSR) and the study's specific statistical analysis plan (SAP).
- Subjects
MEDIDATA Solutions Inc.; PHARMACEUTICAL industry; MEDICAL protocols; CLINICAL trials; STATISTICS
- Publication
Applied Clinical Trials, 2013, Vol 22, Issue 3, p22
- ISSN
1064-8542
- Publication type
Article