This is the program for the 2010 Joint Statistical Meetings in Vancouver, British Columbia.

Abstract Details

Activity Number: 135
Type: Contributed
Date/Time: Monday, August 2, 2010 : 8:30 AM to 10:20 AM
Sponsor: Section for Statistical Programmers and Analysts
Abstract - #308980
Title: How to Improve Efficiency and Productivity of Statistical Output
Author(s): Nancy Wang*+
Companies: Celerion
Address: 621 Rose Street, Lincoln, NE, 68506,
Keywords: Efficiency ; Productivity ; Standardization ; Statistical Output ; Deliverables ; Processes
Abstract:

As a pharmaceutical industry contract research organization(CRO)serving many clients to reach one goal(FDA approval), delivery of statistical output with efficiency and productivity is key to business success. Standardization of output leads to consistent quality, ease of QC/review, reproducible processes, and uniform staff training/expectation. The areas to standardize include: project documents-Data Management Plan, Statistical Analysis Plan and reports; SAS codes-same codes/macro for same analysis/algorithm/presentation; Tables/Listings/Graphs-same presentation for same results; submission data - same structure for same data; and work flow-procedure guidance documentation. Standardized delivery of the common information clinical trials share ensures more attention to study specific details and more time for multiple projects. Details on how to standardize will be shared and discussed.


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