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In Search of the Holy Grail
Most pharma companies, including procter & gamble pharmaceuticals (P&GP), rely on a familiar line-up of information technology solutions to shorten clinical trials timelines, manage data and contain costs. Clinical data management systems (CDMS), clinical trial management systems (CTMS), electronic data capture (EDC), drug supply management (DSM), and interactive voice-response systems (IVRS)—all of these have become commonplace. These IT solutions would be much more powerful if they worked well together.
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Subject Diversity Is Good for the Business of Medicine
With the advent of personalized medicine and purported "race-based therapies" such as BilDil in the news, it is time the pharmaceutical industry makes a more concerted effort to engage racial and ethnic minority groups and the rural poor in clinical research.
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On-Demand: The Next Generation of Packaging and Labeling
With the increasing number of patient-specific and genetically based medications being developed and the globalization of clinical trials, pharmaceutical and biotechnology companies are facing greater pressures to increase efficiencies in clinical trial material (CTM) management. In particular, there is growing demand on clinical supplies teams to minimize CTM repackaging or overage, shorten packaging and labeling timelines, have the flexibility to customize supplies, and reduce the overall costs associated with CTM management.
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The Virtual Revolution (The Time Is Now)
Several environmental factors have recently emerged that are drastically affecting pharmaceutical research and development. The costs associated with the development of a new molecular entity are increasing. In 2003, the Tufts Center for The Study of Drug Development estimated the development costs at $897 million dollars.
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The Clinical Investigative Site Network
The benefits of clinical site networks may outweigh the costs when sponsors consider the enhanced quality and timeliness as well as potential impact on enrollment.
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Reimbursement and Regulation Shape Pharmaceutical Research
The Medicare drug benefit and FDA's Critical Path Initiative will push and pull new drug development.
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