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
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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

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3rd Annual Challenges in Global Clinical Trials Conference, Jan. 28-29, 2010, San Diego, CA.

3rd Annual Challenges in Global Clinical Trials Conference, Jan. 28-29, 2010, San Diego, CA.

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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 Presentation Transcript

  • 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 4
  • 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! The entire presentation is available to registered attendees only! To view the rest of this exciting presentation and many more! Please Register for the 3rd Annual Challenges in Global Clinical Trials Conference at www.gtcbio.com If you are already registered, please contact GTCbio for the full version.