Contract Research and Development Organizations-Their History, Selection, and Utilization

Contract Research and Development Organizations-Their History, Selection, and Utilization

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This volume provides a complete update of all the materials in prior volumes on the subject (including current directories to testing labs and other support establishments worldwide), while adding substantial new material on the following topics:· The history of CROs, including snapshots of CROs and a genealogy chart making clear where they came from and where they went.· 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.Â...