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PHARMACEUTICAL INDUSTRY :
Clinical Trials Electronic Case Report Form Development Process Improvement |
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| | Client: |
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A major pharmaceutical
company supporting a large number of clinical trials using electronic
case report forms.
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| | Problem: | |
It was taking
too long to create the electronic case report forms. The cycle time
was running 12 – 15 weeks versus a process goal of 8 -10 weeks.
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| | Approach: | |
Tunnell worked
with the client’s Electronic Data Capture (EDC) staff to create
a continuous improvement process based on the use of the Six Sigma
methodology. The first wave of improvements included ten projects
worth $2.5 million in cost avoidance. Twelve members of the professional
staff were trained in Six Sigma methodology at the Green Belt level
and successfully completed their projects in 4–8 months. Each
project involved a team of 2-4 people in addition to the Green Belt,
so a large percentage of the EDC workforce was exposed to the Six
Sigma methodology as were the Green Belts. Reducing cycle time and
errors was a key success criteria for a number of the projects.
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| | Results:
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Significant improvements were made to all of the following sub-processes:
A more focused portfolio
Consolidation of key functions such as Quality and Manufacturing
Better alignment, coordination and decision making between line
and staff functions, all with fewer FTEs.
Fewer issues to resolve between key areas
Greater speed to market of newly released drugs, saving millions
Greater employee satisfaction as proven in an employee survey
The overall time
to build an electronic case report form was decreased by approximately
one-third, from 12 - 15 weeks to 8 - 10 weeks. An additional cost
avoidance of approximately $2.5 million was also identified. The managers
and professionals in the EDC group also acquired the improvement skills
needed to conduct other improvement projects in the future.
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