By Gayathri De Lanerolle, Evette Sebastien Roberts, Athar Haroon, Ashish Shetty

Quality Assurance Management: A Comprehensive Overview of Real-World Applications for High Risk Specialties demonstrates how to best design and implement standard operating procedures (SOPs) to ensure protocol and regulation adherence. The book showcases similarities and differences between healthcare and academic quality assurance systems, resulting in counter-productivity and performance issues, in addition to regulatory inspection preparedness. It uses the processes and standards of the UK to demonstrate how to combine QA and research building into ‘building blocks’ that share a common pathway for effective project design, analysis and unbiased interpretation of collated data.This book fills a gap, providing original research in QA that especially focuses on specialist areas. It will be of use to research and clinical staff working in clinical research within healthcare, academia and industry.

Uses practice-based evidence for developing and delivering quality assurance and management systems

Includes case studies associated with ‘failures’ and ‘lessons learned’

Discusses clinical trials in academic, clinical and industry settings

Demonstrates how to build resilience into systems that could evolve to promote best practices, even with limited resources

Compares and contrasts different QA/QC practices