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Improving Clinical Development with Six Sigma
July 12th, 2007
Tim Strauss
Executive Director
Business Process Improvement
Covance
Download this Audio Conference (MP3)
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 provided 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 explored how Six Sigma process improvements can be applied to clinical program execution and provided several real life examples. Other topics of discussion included 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 provided 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.
This audio conference addressed:
- What Six Sigma is and how its principles can be applied to the clinical trials process
- A Six Sigma approach to discrete tasks in a clinical program
- Identifying ways to reduce project management performance variance by shifting the focus from error remediation to error prevention
- Understanding the hurdles to success, including the necessary commitment to change
- Avoiding failure by selecting appropriate projects for Six Sigma
About the speaker:
Tim Strauss joined Covance in 2000 and currently serves as Executive Director, Business Process Improvement for the Late Stage Development business unit. He is responsible for training, mentoring and coaching process owners and project champions in the use of Six Sigma tools, approaches and techniques. Prior to joining Covance, Tim worked in Corporate Reengineering at Telephone & Data Systems in Madison, WI where he led efforts in process improvement and performance measurement, organization development and executive decision support. Tim received his BS from Bowling Green State University and his MA from the University of Wisconsin.
Who should attend?
- Middle & Senior Management — R&D
- Operations
- Program Management
- Risk Mitigation
- Regulatory
- Medical/Scientific
- Outsourcing/Contracts
Download this Audio Conference (MP3) |
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