How a Robust “Lessons Learned" Process Can Help Global Clinical Development Teams Successfully Meet Today\'s Drug Development Challenges Larry Blankstein, Senior Director, Clinical Research Genzyme Corporation
How a Robust “Lessons Learned" Process Can Help Global Clinical Development Teams Successfully Meet Today\'s Drug Development Challenges Larry Blankstein, Senior Director, Clinical Research Genzyme Corporation
1. Implementation of a Robust “Lessons Learned" Process
Can Help Global Clinical Development Teams Successfully
Meet Today's Drug Development Challenges
GTC Conference
January 27-28
San Diego, CA
“Challenges in Global
Clinical Trials”
2. AGENDA
Why Perform Lessons Learned
Lesson Learned Process
Application of Process – Examples
US Study
CRO Study
Summary
3. Tools for Managing Sponsor-Provider Relationships
1) Service agreement
2) Study specifications/Work orders
3) Conference calls
4) Oversight meetings
5) Relationship management plan
6) “Lessons learned” - a non-confrontational
technique to improve sponsor-provider team
performance
3
4. Why Lessons Learned
Capture innovative ideas, knowledge
and experiences
Avoid repeating mistakes
Identify training needs
Identify areas for process and/or organizational
improvement
Optimize relationship between Sponsor and Provider
Document/share knowledge
Improve quality
Competitive advantage - high performing teams
experience knowledge added value
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5. Stages to Lessons Learned Process
Collecting the knowledge
Defining when to collect information
Tools to collect information
Define meeting structure
Sharing the knowledge
Provide meeting summary
Enter information into a database
Storing the knowledge
Easy retrieval of information
6. ATTENTION!
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attendees only!
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more!
Please Register for the
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