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  • Shayne C. Gad; Charles B. Spainhour; David G. Serota
    978-3-030-43073-3
    2020
    Edition 1
    • Addresses the history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went
    • Essential for pharmaceutical and medical device study directors and principal investigators
    • The nuts and bolts of study performance
    • Electronic reporting requirements – SEND and eCTD (required for NDA, BLA, ANDA, and IND submissions)
    • Consultants and their roles
    • An expanded examination of common problems and their solutions

    €180

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