JSM 2004 Online Program

Abstract #301607

This is the preliminary program for the 2004 Joint Statistical Meetings in Toronto, Canada. Currently included in this program is the "technical" program, schedule of invited, topic contributed, regular contributed and poster sessions; Continuing Education courses (August 7-10, 2004); and Committee and Business Meetings. This on-line program will be updated frequently to reflect the most current revisions.

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Activity Number:	193
Type:	Contributed
Date/Time:	Tuesday, August 10, 2004 : 8:30 AM to 10:20 AM
Sponsor:	Biopharmaceutical Section
Abstract - #301607
Title:	Clinical-data-warehousing in Pharmaceutical Research
Author(s):	C. V. Damaraju*+
Companies:	J&J Pharmaceutical Research & Development
Address:	1125 Trenton-Harbourton Rd., Titusville, NJ, 08560,
Keywords:	knowledge discovery ; data warehouse ; safety and efficacy ; standards ; regulatory guidance
Abstract:	Safety and efficacy data constitute the bulk of the pharmaceutical research data repository. An efficient integration of these two components entails knowledge discovery in a timely fashion. We discuss the existing paradigms in data-warehousing for safety and efficacy data and highlight some of the problems faced in structuring a clinical data warehouse. We also note the role of relevant regulatory guidelines in creating and maintaining overall data standards in the pharmaceutical industry.

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