Current aspects of risk management in clinical trials

Abstract

Improving the quality of drugs is the main task of the pharmaceutical industry as a whole. Getting safe and eff ective medications is directly related to minimizing the risks of conducting clinical trials. Maintaining the quality of clinical research based on risk management is a continuous, constant and dynamic process ensuring the success of the study, which in turn leads to the integrity of the data collected, the safety of subjects and compliance with legal requirements, as well as to the financial cost savings of pharmaceutical companies. The cost of research is growing inexorably, and the quality of their research is rapidly declining, so it is important to use a risk-based approach when developing the upcoming clinical trial project.