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regulatory filing is archived, but the study database continues to evolve. Data from ongoing studies continues to flow into the database to be prepared for safety updates. Queries by regulatory authorities of the data that were filed [assuming that a Computer-Aided New Drug Application (CANDA) was not filed or was inadequate or improperly used] can be directed by the CRO/sponsor to the archived database or the authorities can be given access to the appropriate data warehouse. |
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The integrated database will also be the primary source of information for marketing. A plan for general information dissemination can be a component of the overall plan for the development of the drug. That plan might include preparation of abstracts, presentations at symposia, and submissions to peer- reviewed journals. Specifications of analysis and data display requirements can be prepared in a manner similar to that used for preparing specifications for regulatory submissions. The use of statistical and programming time will be both more efficient and of better quality if the efforts specific to general information dissemination occur in parallel with those for regulatory submissions. |
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V. Concluding Observation |
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CROs have truly become an integral component of the drug development process. While it can be expected that pharmaceutical and biotechnology companies will continue to depend on their highly qualified scientists, physicians, regulatory experts, planners, marketing experts, and managers for their unique skills and direction setting, they will rely on CROs to execute the process of drug development in the most efficient manner while achieving standards of excellence. |
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1. Glaxo Annual Report, 1992. |
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2. Glaxo Annual Report, 1993. |
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3. Glaxo Annual Report, 1994. |
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4. I. Schofield. Corruption And Cost Containment In Europe. Scrip Magazine Jan: 7, 1994. |
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5. M. Dower, 1993A Year To Retrench, Restructure, Rethink. Scrip Magazine Jan: 2, 1994. |
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6. Trends In U.S. Pharmaceutical Sales and R&D. 19901993 PMA Annual Survey Report. Pharmaceutical Manufacturers Association, 1993, p.6. |
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7. S. Engel and J.F. Jalkiewicz. Mixing Up A New Formula. Med. Ad. News 12(15): 3, 1993. |
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8. R. B. Giles. Blending Business Boundaries. Pharmaceutical Executive 13(11): 46, 1993. |
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