Vyas G V, Pallavi Garkhede, Rawat S S, Jaybhaye S S, Hatkar A D, Phoke S V, Manisha Garkhede
Control release form, Scientific Body, Party service,clinical research organization
Sometimes also called contract house, clinical research organisation (overall term: trial manon agement organisation), third party service; EC (III): “scientific body (commercial or academic) to which a sponsor may transfer responsibility for some of its tasks or obligations”; FDA: “If a sponsor has transferred any obligations for the conduct of any clinical study to a CRO, a statement containing the name and address of the CRO, identification of the clinical study, and a listing of the obligations transferred may be submitted” (with a new drug application
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Unique Paper ID: 160472

Publication Volume & Issue: Volume 10, Issue 1

Page(s): 675 - 679
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