Clinical trials monitoring methods like risk-based monitoring are crucial for maintaining excellent data quality as well as patient safety. To find possible problems with trial conduct, safety, data integration, and compliance, it uses a variety of techniques and platforms. Clinical study expenditures are decreased and study quality is increased with risk-based monitoring. Regulatory bodies publish risk-based monitoring guideline sheets because they see the potential of risk-based monitoring to enhance clinical trials in all phases. In 2016, the International Conference on Harmonisation (ICH) established a requirement for sponsors to adopt a risk-based monitoring system for clinical trials, according to an article from the National Centre for Biotechnology Information.
Risk-Based Monitoring Market- Drivers :
During the forecast period, the market for risk-based monitoring is anticipated to rise as a result of the decline in the cost of clinical trials. Clinical trials throughout the drug development process are expensive, and it is thought that risk-based monitoring can save those costs by 30%.
As compared to conventional studies, the risk-based monitoring procedure decreases clinical data error, which could fuel market expansion during the projection period. According to the Association of Clinical Research Organisations (ACRO), for instance, a recent study of its members revealed a 16 percent decrease in major findings in audits among sites using this method. As a result, the organisation is urging the FDA to place even more emphasis on risk-based monitoring (RBM) of clinical trials in 2019.
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Risk-Based Monitoring Market- Restraints :
Numerous factors, including devoting time to identifying critical variables, the size and complexity of the trial, stakeholder buy-in, and understanding of regulatory requirements, which determine whether the company is ready for risk-based monitoring, make risk-based monitoring inaccessible to many companies. All of these factors are anticipated to limit the expansion of its installation in several businesses.
Risk-Based Monitoring Market- Regional Analysis :
The risk-based monitoring market is divided into regions based on geography: North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Over the course of the forecast period, North America is anticipated to maintain its dominant position in the risk-based monitoring market. According to the Association of Clinical Research Organisation, risk-based monitoring for clinical trials has been called for to ensure safer, more effective, and higher-quality studies in the US due to growing demand for it in clinical research.
Due to factors including the improvement in the calibre of clinical trial data in the area, the Asia Pacific region is experiencing the highest growth in the risk-based monitoring market. For instance, the China Food and Drug Administration (CFDA) published rules for self-verification and self-checking of newly submitted clinical drug data in July 2015. The effectiveness of ongoing clinical trials will be assessed in this process using risk-based monitoring.
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
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Table of Contents with Major Points:
- Key Findings
- Definitions and Assumptions
- Definition of Risk-Based Monitoring Market
- Market Dynamics
- Trends and Developments
- Key Emerging Trends
- Key Developments Mergers and Acquisition
- New Product Launches and Collaboration
- Partnership and Joint Venture
- Latest Technological Advancements
- Insights on Regulatory Scenario
- Porters Five Forces Analysis
Qualitative Insights Impact of COVID-19 on Global Risk-Based Monitoring Market
- Supply Chain Challenges
- Steps taken by Government/Companies to overcome this impact
- Potential opportunities due to COVID-19 outbreak
- Data Sources
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