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Controlling the Increased Complexity of Electronic Clinical data Collection and Management Technology by data Modeling and System Engineering

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Abstract

Economic realities are forcing pharmaceutical research and development to become more productive. A lot of hope is put on new information technologies, including electronic data capture. However, adding new technologies to existing legacy systems bears the risk of creating informational chaos. This can be avoided by system engineering and data modeling, which focus on the technology independent essence of a system. Computer-aided system engineering tools translate logical models into real databases. As the aeronautical industry proves, rigorous computer-assisted system engineering and modeling is the way to manage highly complex systems successfully. The pharmaceutical industry has yet to make serious contributions to the planning and designing of complex systems.

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Authors and Affiliations

  1. Schering-Plough Research Institute, 2015 Galloping Hill Road, Kenilworth, New Jersey, 07033-1300, USA

    Ülo Palm MD, MBA (Director Clinical Data Management Strategies)

Authors
  1. Ülo Palm MD, MBA
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Palm, Ü. Controlling the Increased Complexity of Electronic Clinical data Collection and Management Technology by data Modeling and System Engineering. Ther Innov Regul Sci 36, 683–692 (2002). https://doi.org/10.1177/009286150203600323

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