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The pharmaceutical industry today is faced with a combination of operational, regulatory, and information challenges. On the business front, companies must increase their productivity and reduce their costs to maintain shareholder return, despite the fact that 75% of R&D expenses are invested in compounds that fail to make it out of the clinical development phase. On the regulatory front, tighter FDA regulations (cGxP) are forcing companies to manage access to electronic records in a more vigilant manner. With regard to information challenges, pharmaceutical companies must manage a complex set of public/private information partner relationships, which are further exacerbated by mergers across multiple organizations and by the explosion of available data to manage, especially during the drug discovery process.
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