RISK-BASED MONITORING MARKET ANALYSIS
Risk-based monitoring is a clinical trials monitoring technique, which is important for ensuring patient safety, and also to maintain high quality of data. It employs various tools and platforms to identify potential issues related to trial conduct, safety, data integration, and compliance. Risk-based monitoring improves the quality and reduces costs associated with clinical studies. Regulatory authorities recognize the potential of risk-based monitoring in order to improve clinical trials of all phases and publish guidance documents on risk based monitoring. According to the National Center for Biotechnology Information article, 2016, at International Conference on Harmonization (ICH) published a requirement for sponsors to develop a risk-based monitoring approach for clinical trials.
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