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PHARMACEUTICAL INDUSTRY :
Clinical Development Plan Process Improvement |
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| | Client: |
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A major pharmaceutical company that develops and maintains Clinical Development Plans (CDPs) for its drug programs.
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| | Problem: | |
The company had ongoing issues creating, managing and updating the CDP process. Potential problems were expected because of the lack of a defined process for transitioning the CDPs into a new computer system.
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| | Approach: | |
Tunnell Consulting
kicked off and chartered a process improvement team, interviewed key
stakeholders in the CDP process, and organized internal feedback on
issues, concerns and suggestions for improvement. We analyzed the
current CDP process and identified enhancement opportunities. Our
findings produced the following actions:
Reviewed and validated feedback and recommendations with project sponsor and project oversight committee
Developed a proposed business process for creating CDPs, transitioning the process into the computer system, and maintaining consistent updates
Determined key roles and responsibilities and defined key interfaces
Recommended a high-level implementation plan
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| | Results:
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Tunnell's improvement
strategy achieved the following results:
Defined and communicated a process for the creation, review and finalization of CDPs
Launched an intuitive, easy-to-navigate, time-saving software application for the process
Increased quality by ensuring employees were well-trained so CDPs can be tracked, version-controlled and finalized individually
Created a plan for communication and training to ensure consistent implementation
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