Whitepaper

With increased clinical R&D budgetary constraints and complexities of clinical development, risk management has become an essential and integral piece of clinical trial management to ensure good return on investment. The core of risk management is the identification and assessment of the risks in the beginning and on a continuous basis for riskbearing activities of a clinical trial. After issuance of the guidance on Risk-Based Monitoring by FDA, the sponsors/CROs have demonstrated keen interest in adopting a systematic approach to risk assessment in clinical trials. Risk assessment is a systematic process for identifying and evaluating events that could affect the achievement of clinical study objectives. A robust risk assessment process in clinical trials forms the foundation for an effective risk management approach. It is all about taking a holistic approach to identify all potential risks and evaluate those risks to assess the probability of occurrence and impacts.Effective risk action planning involves effective risk identification and proactive root cause analysis. A right implementation of a robust risk assessment process empowers a study management team to better identify and evaluate the right risks for a clinical trial, all while maintaining the appropriate controls to ensure effective and efficient quality conduct, patient  safety and regulatory compliance Risk