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Site management organizations

Site management organizations provide physician investigators, qualified patients, and support personnel for inpatient and outpatient clinical trials for single site or multicenter clinical trials. These firms provide services to sponsors and CROs. They are included in the CRO industry revenue totals, and unlike CROs they incorporate per pahent grant funds in their revenues. [Pg.413]

Some dedicated sites maintain loose affiliations with non-competing sites to share leads about upcoming studies. Others belong to a site management organization (SMO), which is a formal affiliation offering centralized management,... [Pg.127]

A multitude of external providers are used to deliver services in clinical trials, for example CROs, site management organizations (SMOs) and academic research organizations (AROs). To ensure that they are capable of providing the services in a reliable manner and to the standards expected in compliance with current regulatory requirements, capability audits are conducted at service providers prior to contracting. [Pg.175]

CROs and site management organizations (SMOs) are organizations that run clinical trials, using physicians who are full-time, part-time or contract employees. The companies employ regulatory staff, for IRB filing, adverse event notification and so on, as well as site coordinators,... [Pg.650]

Fig. 2 This figure represents the career options for individuals interested in the clinical pharmaceutical sciences. Abbreviations PhaRMA, Pharmaceutical Research Manufacturers CROs, Contract Research Organizations SMOs, Site Management Organizations NIH, National Institutes of Health CDC, Center for Disease Control and Prevention HCFA, Health Care Financing Administration FDA, Food and Drug Administration EPA, Environmental Protection Agency CDER, Center for Drug Evaluation Research CBER, Center for Biological Evaluation Research. Fig. 2 This figure represents the career options for individuals interested in the clinical pharmaceutical sciences. Abbreviations PhaRMA, Pharmaceutical Research Manufacturers CROs, Contract Research Organizations SMOs, Site Management Organizations NIH, National Institutes of Health CDC, Center for Disease Control and Prevention HCFA, Health Care Financing Administration FDA, Food and Drug Administration EPA, Environmental Protection Agency CDER, Center for Drug Evaluation Research CBER, Center for Biological Evaluation Research.
Site management organizations have aggressive aims to reengineer and overhaul the clinical development process through consolidating the fragmented and unsophisticated... [Pg.507]

See other pages where Site management organizations is mentioned: [Pg.407]    [Pg.408]    [Pg.413]    [Pg.419]    [Pg.420]    [Pg.425]    [Pg.457]    [Pg.457]    [Pg.458]    [Pg.462]    [Pg.2486]    [Pg.523]    [Pg.179]    [Pg.449]    [Pg.505]    [Pg.506]    [Pg.508]    [Pg.511]    [Pg.543]    [Pg.459]   
See also in sourсe #XX -- [ Pg.523 ]



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