Drug development is risky business. It is against the backdrop of huge financial, scientific, technical and medical risks that a clinical trials manager is expected to function, effectively identifying and managing all project risks, to deliver a successful outcome. Focusing on the day-to-day needs of a clinical trials manager, Clinical Trials Risk

chapter 1|24 pages

Definitions and Concepts

chapter 2|14 pages

Assessing Drug Safety

chapter 3|22 pages

International Regulatory Perspectives

chapter 4|18 pages

Types of Risk in Clinical Trials

chapter 5|16 pages

Risk Identification and Quantification

chapter 6|14 pages

Threats and Opportunities

chapter 7|16 pages

Planning Preventative Strategies

chapter 8|18 pages

Backup Planning

chapter 9|26 pages

Project Tracking and Decision-Making

chapter 10|18 pages

Investigational Site Risk Management

chapter 11|10 pages

Post-Project Evaluation