A key element of Risk-Based Monitoring is the verification of source data to ensure its validity and accuracy. This is done by comparing the reported information to the original study records. Another key component is the use of a targeted monitoring strategy, focusing on critical data and selected patients.The implementation of a risk-based monitoring program involves allocating resources to areas of greatest risk. The goal is to optimize the use of resources while maintaining the safety and quality of data. Many organizations have seen considerable savings by implementing a risk-based monitoring program.
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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
Reducing cost in clinical trials is a major factor that is expected to drive growth of the risk-based monitoring market. During the process of 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%.
Using risk-based monitoring process reduces the clinical data error also in comparison to traditional studies. This is driving growth of the market. 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 organization 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 projected to restrict the growth of its installation in many companies.
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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. Due to growing 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, due to factors such as enhancement 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.
- Clinical Trials
- Clinical Studies
By End Users
- Pharmaceutical Industry
- Biotech Industry
- Academic Research Center
- North America
- Latin America
- Asia Pacific
- Middle East
𝗕𝘂𝘆 𝗡𝗼𝘄 𝗧𝗼 𝗚𝗲𝘁 𝗙𝗹𝗮𝘁 30% 𝗢𝗳𝗳
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Table of Content
Chapter 1 Industry Overview
1.3 Research Scope
1.4 Market Analysis by Regions
1.5 Global Risk-Based Monitoring Market Size Analysis from 2021 to 2027
11.6 COVID-19 Outbreak: Risk-Based Monitoring Industry Impact
Chapter 2 Global Risk-Based Monitoring Competition by Types, Applications, and Top Regions and Countries
2.1 Global Risk-Based Monitoring (Volume and Value) by Type
2.3 Global Risk-Based Monitoring (Volume and Value) by Regions
Chapter 3 Production Market Analysis
3.1 Global Production Market Analysis
3.2 Regional Production Market Analysis
Chapter 4 Global Risk-Based Monitoring Sales, Consumption, Export, Import by Regions (2016-2021)
Chapter 5 North America Risk-Based Monitoring Market Analysis
Chapter 6 East Asia Risk-Based Monitoring Market Analysis
Chapter 7 Europe Risk-Based Monitoring Market Analysis
Chapter 8 South Asia Risk-Based Monitoring Market Analysis
Chapter 9 Southeast Asia Risk-Based Monitoring Market Analysis
Chapter 10 Middle East Risk-Based Monitoring Market Analysis
Chapter 11 Africa Risk-Based Monitoring Market Analysis
Chapter 12 Oceania Risk-Based Monitoring Market Analysis
Chapter 13 South America Risk-Based Monitoring Market Analysis
Chapter 14 Company Profiles and Key Figures in Risk-Based Monitoring Business
Chapter 15 Global Risk-Based Monitoring Market Forecast (2021-2027)
Chapter 16 Conclusions
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