Versante provides expert statistical and analytical support that is second to none. We ensure appropriate statistical analysis and reporting that are consistent with the protocol and the statistical analysis plan.
Statistical Analysis Services Include:
Consultation during protocol development including considerations for adaptive designs
Determination of appropriate statistical methodologies
Development of Statistical Method’s sections for study protocols
Simulation studies to identify and define the best endpoints
Sample size and power analysis
Generation of randomization plans
Interim and final analysis of study data
Participation in Data Safety Monitoring Boards
Preparation for, and representation of, client cases before regulatory authorities
All plans are designed to comply with ICH guidelines and incorporate sponsor comments:
Our biostatisticians keep current with the latest statistical techniques in the literature, as well as those accepted by the FDA. Our senior biostatisticians have served as independent reviewers of major studies in many therapeutic areas. Our SAS-certified statistical programmers bring a wealth of knowledge of the latest programming techniques and features of the SAS system and other statistical software packages. We provide a library of standardized and tested templates. We also pay significant attention to all details in order to deliver the highest quality and most dependable analyses.
Statistical Analysis and Reporting
Clinical Plan Development
Protocol Development and Study Design
Therapeutic Expertise Consultation
Data Management
Electronic Data Capture (EDC)
CDISC Conversion
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