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Activity Number:
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51
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 6, 2006 : 4:00 PM to 5:50 PM
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Sponsor:
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Section on Statistical Computing
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| Abstract - #306409 |
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Title:
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Software and Code Evaluation: Risk-Based Approaches to Software Integration
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Author(s):
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Nicholas J. I. Lewin-Koh*+ and Robert A. Myers
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Companies:
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Eli Lilly and Company and Eli Lilly and Company
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Address:
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Corporate Center, Indianapolis, IN, 46285,
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Keywords:
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software ; open source ; clinical reporting ; risk assessment
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Abstract:
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Decisions in the pharmaceutical world are motivated by FDA requirements, especially in clinical phases. However phases of the industry are less regulated and require more flexible approaches to data management. A possible approach to selecting software can be based on competing risks. More regulated environments incur higher risk when security can be compromised and higher cost when the burden of validation must be incurred with company resources. In contrast, in pre-clinical and discovery phases, risk is determined by the ability to adapt to new technologies and processes. Costs are elevated by extensive validation requirements, which are more severe when regulation is tighter. We see a role for open source tools in areas where validation costs are minimal in relation to the complexity of the software requirements.
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