The pharmaceutical industry of today is faced with a combination of operational, regulatory, and informational challenges. Pharmaceutical companies must increase their productivity and reduce costs to maintain shareholder return, despite the fact that most research and development (R&D) expenses are invested in compounds that fail to make it out of the clinical development phase. Tighter FDA regulations (cGxP ) are forcing companies to more vigilantly manage access to electronic records. And on the information front, pharmaceutical companies must manage a complex set of public and private partner relationships that require information sharing, a challenge that is exacerbated by mergers and acquisitions and by an explosion in the volume of data to manage, especially during the drug discovery process.
Much of a company’s information is structured according to the functional silos of major business areas, such as research and development, manufacturing, sales, and marketing, with a central corporate entity to manage the whole organization. These business areas function autonomously in many cases, and for a pharmaceutical firm, the number of silos grows with the many different therapeutic areas and brands in the company’s product portfolio.