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

Focusing on the day-to-day needs of a clinical trials manager, this book explains the key concepts and principles of risk management, as well as showing how best to how to apply them directly to 'real life' clinical trial situations. After building a foundation of basic principles, the authors lead readers through specific methods for handling the risks characteristically encountered in clinical trials. They discuss concepts using worked examples and include a summary of the main points at the end of each chapter. In addition to diagrams and Risk and Precision Tree charts, the text is sprinkled with humorous line drawings that reinforce the concepts.

Definitions and Concepts. Drug Safety and Pharmacovigilance. Types of Risk in Clinical Trials. Risk Identification. Threats and Opportunities. Planning Preventative Strategies. Backup Planning. Tracking Risks. Investigational Site Risk Management. Post Projection Evaluation.