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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”
AGENDA
 Why Perform Lessons Learned

 Lesson Learned Process

 Application of Process – Examples
      US Study
      CRO Study


 Summary
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
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
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
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.

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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

  • 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.