Abstract
In response to an unprecedented level of internal and external pressures, pharmaceutical and biotechnology companies are seeking ways to aggressively reduce costs, streamline processes, and minimize the risks associated with clinical development. Site selection is one area that has not been fully used by these companies but represents a significant opportunity to improve project planning, reduce project costs, and generate incremental revenues. A strategic information-based and systematic approach—drawn from principles in portfolio theory—is presented and tested in this paper. Individual site performance measures (ie, quality, cost, and speed) are analyzed to modify the mix of centers selected to conduct a pivotal central nervous system (CNS) trial. Results show that the proposed “portfolio approach” can potentially yield savings between 10 and 20 months in a project's development time and several hundred thousand dollars in a project's costs.
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