Outsourcing regulatory activities : How a policy can drive good decisions. Commentary
In: Special Issue on Regulatory Affairs, Jg. 34 (2000), Heft 3, S. 981-989
academicJournal
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Zugriff:
In order to utilize resources more efficiently in an increasingly competitive environment, the pharmaceutical industry is outsourcing a large volume of drug development activities to contract research organizations (CROs). These organizations allow companies to access expertise and/or augment internal resources during times of peak demand. Until recently, a majority of this outsourcing activity was focused on clinical development rather than regulatory activities. As companies strive to do more with less and do it faster, however, regulatory activities are increasingly being considered for outsourcing to enable the efficient use of resources. In order for a company to be successful in the management of the outsourcing process an internal policy should be developed. A policy will communicate the regulatory outsourcing strategy to internal departments and the CRO and provide consistency in outsourcing decisions. The objective of this article is to provide information, which can be used to develop a company specific policy on outsourcing regulatory activities to a CRO. The goals of outsourcing, aspects of policy development, and a framework for decision making, including examples, are discussed.
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Outsourcing regulatory activities : How a policy can drive good decisions. Commentary
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Autor/in / Beteiligte Person: | BATES, Suzanne ; SLOAN, Elizabeth ; MILLER, Loren |
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Zeitschrift: | Special Issue on Regulatory Affairs, Jg. 34 (2000), Heft 3, S. 981-989 |
Veröffentlichung: | New York, NY; Oxford; Séoul: Pergamon Press, 2000 |
Medientyp: | academicJournal |
Umfang: | print, 4 ref |
ISSN: | 0092-8615 (print) |
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