Using SAS^Ž 9 in clinical research

Author: Nelson, Gregory

Source: Pharmaceutical Programming, Volume 2, Number 1, August 2009 , pp. 53-59(7)

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Abstract:

For 30 years, SAS has been used in pharmaceutical research settings for data management, analytics and reporting. Traditionally, these roles were staffed by the BASE SAS programmer and the statistician. At the same time, dramatic shifts in the research informatics eco-system have occurred with advances in standards, such as CDISC, ICH and HL7, and the convergence of clinical data management systems and modernization strategies, such as electronic data capture and 21 CFR Part 11. This paper provides a broad based view of solutions SAS provides across the research information spectrum. We are at an interesting crossroads: on the one hand, the power of traditional SAS approaches found in BASE and STAT; on the other hand, a new range of technologies grown out of the SAS 9 platform, such as the Metadata Server, Data Integration Studio and SAS Business Intelligence products. The SAS Drug Development solution merges the accessibility of the Internet with the clinical trial workflow. Whether your focus is beating data into submission or making it sing and dance in reports, this paper will make the connections to the various solutions from SAS and where each solution is most valuable in the pharmaceutical setting. This paper is appropriate for people at all levels and across the spectrum of job skills, including the production of clinical study reports, pharmacovigilence and safety reporting, sales force optimization, clinical trials management and laboratory data analysis. It is specifically designed for the programmer, statistician, manager and system administrator.

Keywords: ICH; CDISC; SAS DRUG DEVELOPMENT; DATA INTEGRATION STUDIO; SAS 9; BUSINESS INTELLIGENCE; METADATA; HL7; CLINICAL RESEARCH

Document Type: Research Article

DOI: http://dx.doi.org/10.1179/175709206X372245

Affiliations: ThotWave Technologies, Cary, NC, USA

Publication date: 2009-08-01

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