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within the pharmaceutical companies, where it is advantageous to have the time to present the data in its best light prior to any review. |
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Taken to its logical conclusion, the virtual organization will extend to include doctors and patients worldwide. The use of electronic case reports linked to hospital notes and of remote data entry by doctors to provide information for the clinical trials phase makes them all part of the virtual organization. As desire for outcomes data increases to justify a drug's cost and position in the market, postapproval of more sophisticated Phase IV Trials will be required. |
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These organizational changes will create greater amounts of information, a valuable asset in all industries, but especially in the pharmaceutical industry where the collection and use of data is fundamental in the drug development process. This information needs to be managed effectively to realize its full benefits. Information and its effective management will be the competitive weapon to take successful pharmaceutical companies into the next decade. Establishing a bank of accessible information (a data warehouse) will provide a core source of information upon which tools can be built to analyze and model future scenarios. Collecting information will become increasingly automatic, instantaneous and in a common format, making understanding and interpreting it simpler. |
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The major developments in IT described in section III of this chapter, together with appropriate organization and cultural change, will enable these improvements to happen. |
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V.
Future Visions of Pharmaceutical Project Management |
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Although a lot of the changes are positive steps toward greater efficiency within pharmaceutical companies, their occurrence does not necessarily make the job of pharmaceutical project management easier. These changes create new challenges for the pharmaceutical project manager whose role must adapt, not only to cope with the changes, but to reap the most advantage from them. |
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The foremost concern is the resistance to change among company personnel. A high level of staff morale must be maintained alongside the introduction of new ideas, whether new organizational structures, new business practices, or new IT systems. To do this, establishing a clear operating model is essential. In many cases, the choice of operating model is irrelevant as long as it is acceptable to all staff members and has well-defined roles |
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