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  • To Be Published : Nov 2023
  • Code : CMI3575
  • Pages : N/A
  • Formats :
      Excel and PDF
  • Industry : Healthcare IT

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.

Risk-Based Monitoring Market- Drivers

Reduction in the cost of clinical trials is a major factor that is expected to drive growth of the risk-based monitoring market during the forecast period.  During drug development, the cost of clinical trials is high, and it is estimated that risk based monitoring can reduce the cost of clinical trials by 30%.

 Risk-based monitoring process reduces the clinical data error also in comparison to traditional studies which can drive the risk-based monitoring market growth during the forecast period. For instance, according to the Association of Clinical Research Organizations (ACRO) in 2019 is urging the FDA to place even more emphasis on risk-based monitoring (RBM) of clinical trials, saying a recent study of its members showed a 16 percent reduction in major findings in audits among sites using this method.

Risk-Based Monitoring Market- Restraints

Risk-based monitoring is un-accessible to many companies because of many factors, such as devoting time to identify critical variable, size and complexity of  the trial, stakeholder buy in, understanding of regulatory requirement, that determine the whether the company is ready for risk-based monitoring. All these parameters are expected to restrain the growth of its installation in many companies.  

Risk-Based Monitoring Market- Regional Analysis

On the basis of region, the risk-based monitoring market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to hold a dominant position in the risk-based monitoring market over the forecast period. Owing to increasing demand for risk-based monitoring in clinical studies, according to the Association of Clinical Research Organization in May 2017 has called the risk based monitoring for clinical trials to ensure safer, efficient and quality studies in the US.

Asia Pacific is the fastest growing market for risk-based monitoring, owing to factors such as improvement in the quality of clinical trials data in the region. For instance, in July 2015, the China Food and Drug Administration (CFDA) announced self-checking and verification requirements for new and submitted clinical drug data. In this process, risk-based monitoring will be used to evaluate performance of ongoing clinical trials.

Risk-Based Monitoring Market- Competitive Landscape

Key players operating in the risk-based monitoring market include TransCelerate, Bio Pharma Inc., Covance solution, Quanticate Ltd, IQVIA, Parexel, JMP clinical, and Cintec.

Risk-Based Monitoring Market- Taxonomy

The risk-based monitoring market is segmented on the basis of application, end users, and region.

By Application

  • Clinical Trials
  • Clinical Studies

By End Users

  • Pharmaceutical Industry
  • Biotech Industry
  • Academic Research Center

By Region

  • North America
  • Latin America
  • Europe
  • Asia Pacific
  • Middle East
  • Africa

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