书目名称 | Contract Research and Development Organizations-Their History, Selection, and Utilization | 编辑 | Shayne C. Gad,Charles B. Spainhour,David G. Serota | 视频video | | 概述 | 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 a | 图书封面 |  | 描述 | .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...· An expanded examination of common problems and their solutions. ..This book boastscomplete directories to the global universe of operating labs – where they are, how to contact them, and what they do (including special capabilities). Additionally, checklists for qualifying labs and manufacturing facilities – and for auditing studies and projects at such facilities – are included. It is directed at those in industry (specifically directed at those working for companies using CRO services) but will also be of interest to scientists or administra | 出版日期 | Book 2020 | 关键词 | CROs; Pharmaceutical consultants; Pharmaceutical and medical device Product Development; Pharmaceutical | 版次 | 1 | doi | https://doi.org/10.1007/978-3-030-43073-3 | isbn_softcover | 978-3-030-43075-7 | isbn_ebook | 978-3-030-43073-3 | copyright | Springer Nature Switzerland AG 2020 |
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