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  • Sanam replied to the topic CROs in the forum Clinical Trials for Medical Devices 7 years ago

    A sponsor may transfer any or all of the sponsor’s trial-related duties and functions to a CRO, but the ultimate responsibility for the quality and integrity of the trial data always resides with the sponsor. Real benefit is that the sponsor does not have to spend their time investing in training the CRO resources for regulatory compliance, project knowledge, industry standards knowledge, or compound knowledge. The expertise and experience should already be there at the CRO project team. The sponsor company does not need to invest in time or cost training the CRO. CRO will setup their process and programs to follow the latest regulatory. requirements. The quality and consistency of the project are reliable. Great advantage to the pharmaceutical manufacturer, it gives the chance to hold the fixed costs at a minimum during the time of going over to the next project, if the project’s results are not positive. The disadvantages are sponsor is generally hands-off in team selection, and as a result, the CRO will consider placing less costly, and thus, less experienced personnel on the project and still attempt to deliver it correctly. The valuable knowledge and experience gained about a compound in development is a benefit that goes directly to the CRO hands, and may be passed to future projects from other sponsors.