ABSTRACT
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
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.
