Whitepaper

Risks are an integral part of clinical trials. We routinely come across various risks while managing clinical trials which are related to quality, safety, timeline, or budget and they may easily a ect the objectives and outcomes of the trials. Risk management, which involves risk identi cation, assessment, planning, tracking and controlling, is an important aspect that one has to look into to ensure successful completion of a clinical trial. With increased clinical R & D budgetary constraints and complexities of clinical trials, risk management has become an essential piece of clinical trial management to ensure good return on investment. The core of risk management is the ident cation and assessment of the risks on a continuous basis for risk-bearing activities throughout the planning, conduct and close-out phase of clinical trials