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Organizations involved: sponsor pharma/biotech, clinical research organizations (CROs) running trials, clinical sites and investigators, central labs, data monitoring boards, regulatory agencies (FDA, EMA, PMDA, NMPA, CDSCO), and regulatory consultants for dossier preparation Patient Support & Services After approval, the focus shifts to market access, pricing, and reimbursement negotiations with healthcare payers

Multiple lines of evidence support this interpretation

[4] Rosenstock J, Frias J, Jastreboff AM, Du Y, Lou J, Gurbuz S, Thomas MK, Hartman ML, Haupt A, Milicevic Z, Coskun T

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AACE 2015