Clinical Research Updates - Quality Assurance and Clinical Research
Euromed Communications Ltd, June 2012, Pages: 55
Clinical Research Updates bring together guidance on everything to do with clinical trials, from pharmacokinetics and study design, to recruitment, monitoring, protection of subjects, statistics, budgeting ... all the compliance areas you need to conduct clinical trials that will conform to the regulations.
Written by some of the finest experts working in the clinical trials field, Clinical Research Updates translate regulations and best practices into real-world guidance. Both new and experienced trial managers will find the information they need to set up and run every phase of a clinical research program - from drug discovery through post marketing surveillance - in the US or abroad.
Focusing on the US, Europe and Asia, Clinical Research Updates have been updated in 2012 to make it the most current and comprehensive resource available
Introduction
Quality and Quality Management
The Quality Assurance Function
Conduct of an Audit
QAAudits
Methods in QA
The Role of Quality Assurance in Cases of Suspected Misconduct
and Fraud
The Role of Quality Assurance in Regulatory Inspections
Conclusion
References
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