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...
| Main Authors: | , , |
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| Format: | eBook |
| Language: | English |
| Published: |
Cham
Springer International Publishing
2020, 2020
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| Edition: | 1st ed. 2020 |
| Subjects: | |
| Online Access: | |
| Collection: | Springer eBooks 2005- - Collection details see MPG.ReNa |
Table of Contents:
- Introduction
- History of CROs: Including CRO Snapshots and a CRO Genealogy Chart
- The Pharmaceutical Development Process & Testing Requirements
- The Medical Device Development Process & Testing Requirements
- Functions and Types of CROs
- Labs in China and India
- Selection of CROs
- Study Directors and PIs
- Nuts and Bolts of Study Performance SCG/CBS
- Electronic Reporting Requirements (SEND & eCTD)
- Study and Project Monitoring
- Contracting, Pricing, and Cost of Works Performed by CROs
- Consultants and their Role
- Building Relationships: Maximizing your return on Expectations with a CRO
- Common Problems and their Solutions
- Appendices: A Toxicology Labs B Medical Device Labs C Phase I Labs D Analytical Labs E GMP Contract Facilities F Formulation G Dosage Forms H Clinical Testing I Regulatory Services J Forms and Checklists
- K Specialized Services
- L Consultants Known to be In-Practice
- Index.