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

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

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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.
New products
Research and development contracts
Electronic books.
Format: E-Resource Book
URL for this record:http://pi.lib.uchicago.edu/1001/cat/bib/12606580
Hidden Bibliographic Details
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
Table of Contents:
  • Intro
  • Preface
  • Selected Regulatory and Toxicological Acronyms
  • Contents
  • Contributors
  • 1: Introduction
  • Consultants
  • Defining the Project
  • Development of the Study Record
  • Research Plan
  • General Considerations
  • Standard Operating Procedures
  • Regulatory Performance
  • Data Recording
  • Analysis of the Data
  • Reporting of Results and Conclusions
  • Types of Data
  • Raw Data
  • Other Types of Data
  • Computerized Data Collection
  • Statistical Data
  • Results and Conclusions
  • Development of Study Data
  • Quality Characteristics
  • Recording Raw Data
  • General Requirements for Raw Data Recording
  • Error Correction in Data Recording
  • Formats for Recording Data
  • Laboratory Notebooks
  • Results
  • Forms and Worksheets
  • Automated Data Collection Systems (LIMS - Laboratory Information Management System)
  • Computer-Generated Raw Data
  • Electronic Signatures
  • Spreadsheets
  • Reporting the Data
  • Distinguishing Essential from Negotiable Study Elements
  • Designating the Study Monitor
  • Shifting Paradigms
  • References
  • Additional Reading
  • 2: The History of CROs: Including CRO Snapshots
  • Introduction
  • The Early Years
  • Food Drug Research Laboratories
  • Lakeside Laboratories
  • Illinois Institute of Technology Research Institute
  • Chemical Hygiene Fellowship (Bushy Run Research Center)
  • Southern Research Institute
  • Hazleton Laboratories
  • SRI International
  • Lovelace Biomedical
  • Charles River
  • The Middle Years
  • Industrial Biotest
  • Woodard Research
  • Gulf South Research Institute
  • Bio/Dynamics
  • Litton Bionetics, Inc.
  • International Research and Development Corporation
  • Bio-Research Laboratories (Canada)
  • Ricera
  • Calvert Laboratories
  • Experimental Pathology Laboratories
  • MB Research Laboratories
  • Pacific BioLabs
  • Utah Biomedical Toxicology Laboratories
  • Stillmeadow, Inc.
  • Toxicology Pathology Services, Inc.
  • WIL Research
  • Springborn Institute for Bioresearch
  • Hazleton Munster
  • Borriston Laboratories
  • Argus Research Laboratories
  • The Later Years
  • Toxicology Research Laboratory at the University of Illinois at Chicago
  • International Toxicology Research
  • Smithers Avanza
  • Sinclair Research
  • Sierra Biomedical
  • Northern Biomedical Research
  • MPI Research
  • Covance, Inc.
  • Burleson Research Technologies, Inc.
  • SNBL USA
  • Experimur
  • Wuxi
  • Xenometrics
  • CiToxLAB
  • Acknowledgment of Contributors
  • Trends and the Dark Side of the Story
  • References
  • 3: Pharmaceutical Development
  • Safety
  • Pharmaceutical Development
  • Pharmacology
  • Analytical
  • Clinical
  • Regulatory
  • Putting It All Together
  • References
  • 4: Medical Device Development
  • Biocompatibility
  • Fundamentals of Biocompatibility Tests
  • Clinical Testing
  • Market Characteristics
  • Changing Focus, Changing Oversight
  • The Review Speed Problem
  • References

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