Contract research and development organizations -- their history, selection, and utilization /

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 an...

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Bibliographic Details
Author / Creator:Gad, Shayne C., 1948-
Imprint:Cham : Springer, 2020.
Description:1 online resource
Language:English
Subject:Research and development contracts.
New products.
Pharmacy / dispensing.
Pharmacology.
Medical -- Pharmacy.
Medical -- Pharmacology.
New products
Research and development contracts
Electronic books.
Electronic books.
Format: E-Resource Book
URL for this record:http://pi.lib.uchicago.edu/1001/cat/bib/12606580
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Other authors / contributors:Spainhour, Charles B.
Serota, David G.
ISBN:9783030430733
3030430731
3030430723
9783030430726
Notes:Includes index.
Summary: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 boasts complete 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 administrators working in research organizations themselves. In this case, the contents of this new work are essential to the target reader because the work, regulations, and actors (CROs) have evolved and changed at a rapid pace in the 10 years since the earlier volume that the author published. Likewise, the companies using these services have come to all be almost completely dependent on outsourcing. The earlier texts remain the only source of their kind (paper or electronic) on the field and the only noncommercial guide to the global industry and this volume provides a complete update.
Other form:Original 3030430723 9783030430726
Standard no.:10.1007/978-3-030-43073-3
10.1007/978-3-030-43