Contract Research and Development Organizations-Their History, Selection, and Utilization (Paperback, 2020)

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.