The current industry model for drug development is premised on failure by the investigative sites, and most funds are spent finding and repairing mistakes. In comparison to most other industrial systems in the last 30 years, this reactive and repair-focused approach is an anachronism, which causes delays and cost overruns. In contrast, Six Sigma facilitates a systematic attack against site and project management performance variance by shifting the focus from error remediation to error prevention.
This presentation provides a high-level introduction to Six Sigma, practical examples of how has Six Sigma has been deployed, and its impact on drug development. The speaker explores how Six Sigma process improvements can be applied to clinical program execution and provide several real life examples. Other topics of discussion include hurdles to success, necessary organizational commitments to support transformative measures such as Six Sigma, and what types of results can be expected.
Six Sigma is NOT a quick fix for all development woes, and this presentation will provide examples not only of the good, but also the bad and the ugly, where Six Sigma projects were inappropriately selected or scoped, or not well operationalized.
Improving Clinical Development with Six Sigma was presented by Tim Strauss, Executive Director Business Process Improvement of Covance on 2007-07-12. This audio conference is available for download at www.fxconferences.com
