Risk-based Monitoring Software Market by Function (Centralized Monitoring, Reduced Monitoring, Remote Monitoring), Delivery Mode (Cloud-Based, Licensed Enterprise, Web-Based), End-User - Global Forecast 2024-2030

Risk-based Monitoring Software Market by Function (Centralized Monitoring, Reduced Monitoring, Remote Monitoring), Delivery Mode (Cloud-Based, Licensed Enterprise, Web-Based), End-User - Global Forecast 2024-2030


The Risk-based Monitoring Software Market size was estimated at USD 409.38 million in 2023 and expected to reach USD 452.94 million in 2024, at a CAGR 10.91% to reach USD 845.13 million by 2030.

Risk-based monitoring (RBM) software provides clinical teams with a single platform that transforms numerous study data streams into actionable analytics. RBM software improves the quality and compliance of a clinical trial or program. A risk-based monitoring software feeds data from study sites into a dashboard, which then alerts the sponsor to situations that need further investigation. The increase in the number of clinical trials and financial support from governments worldwide for drug discovery and development is expanding the use of RBM software. However, the high cost of implementation and installation of RBM software may limit their adoption by pharmaceutical and biopharmaceutical companies. Moreover, advancements in RBM software to improve the operational efficiency of the software and growing outsourcing of clinical trial processes are expected to increase the deployment of RBM software across pharmaceutical companies.

Regional Insights

The utilization of risk-based monitoring (RBM) software is increasing in the Americas, and Europe, attributed to the highly developed pharmaceutical sector in the region. The growing investments in the APAC region for the drug discovery process and surge in clinical trials to determine the effectiveness and safety of drugs are raising the need for efficient data analyzing and management solutions such as risk-based monitoring software. Additionally, pharmaceutical companies and research institutions are outsourcing preclinical services from contract research organizations (CROs) to aid the cost-effective development of drugs. Moreover, the rapid expansion of clinical research institutes across the APAC region is creating significant potential for the deployment of RBM software. In August 2022, a new research institute, the Cumming Global Centre for Pandemic Therapeutics, was established in Australia to develop drugs to treat diseases caused by pathogens that could cause global pandemics. Moreover, the technological advancements and improvements in risk-based software for creating actionable datasets to support clinical programs and research are expected to encourage their adoption by pharmaceutical companies and CROs worldwide.

Market Insights
  • Market Dynamics

    The market dynamics represent an ever-changing landscape of the Risk-based Monitoring Software Market by providing actionable insights into factors, including supply and demand levels. Accounting for these factors helps design strategies, make investments, and formulate developments to capitalize on future opportunities. In addition, these factors assist in avoiding potential pitfalls related to political, geographical, technical, social, and economic conditions, highlighting consumer behaviors and influencing manufacturing costs and purchasing decisions.
    • Market Drivers
      • Need for proactive approach to monitoring clinical trials with the use of risk-based monitoring software
      • Rising number of clinical trials to determine new form of treatment and effectiveness of drugs
      • Government grants and regulatory compliance for the quality and safety of clinical trials
      • Market Restraints
        • Complex implementation of the RBM software and organization reluctance to RBM software
        • Market Opportunities
          • Technological advancements in risk-based monitoring software
          • Rising trend of outsourcing end-to-end services by pharmaceutical companies
          • Market Challenges
            • Data security and privacy concerns associated with RBM software
            • Market Segmentation Analysis
              • Function: Emergence of ​​risk-based monitoring softwares for remote monitoring activities
              • Delivery Mode: Advancements in cloud-based delivery of risk-based monitoring softwares
              • Market Disruption Analysis
              • Porter’s Five Forces Analysis
              • Value Chain & Critical Path Analysis
              • Pricing Analysis
              • Technology Analysis
              • Patent Analysis
              • Trade Analysis
              • Regulatory Framework Analysis
              FPNV Positioning Matrix

              The FPNV positioning matrix is essential in evaluating the market positioning of the vendors in the Risk-based Monitoring Software Market. This matrix offers a comprehensive assessment of vendors, examining critical metrics related to business strategy and product satisfaction. This in-depth assessment empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success, namely Forefront (F), Pathfinder (P), Niche (N), or Vital (V).

              Market Share Analysis

              The market share analysis is a comprehensive tool that provides an insightful and in-depth assessment of the current state of vendors in the Risk-based Monitoring Software Market. By meticulously comparing and analyzing vendor contributions, companies are offered a greater understanding of their performance and the challenges they face when competing for market share. These contributions include overall revenue, customer base, and other vital metrics. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With these illustrative details, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.

              Recent Developments
              • Cloudbyz Unveiled Groundbreaking Electronic Data Capture Solution to Streamline Clinical Research and Accelerate Launch of New Therapies

                CloudByz unveiled its groundbreaking Electronic Data Capture (EDC) solution, a highly sought-after tool developed to streamline clinical research and accelerate the launch of new therapies. Focusing on risk-based monitoring principles, this EDC technology promises to keep data secure while reducing trial costs and simplifying the workflow process. Its user-friendly dashboard lets users quickly access protocol lists, trial arms info, enrollment summaries, and other related content. Moreover, real-time reporting offers fast insights into the most important components of a clinical trial.

                Clario Launched Cloud-Based Image Viewer for Clinical Trials

                Clario launched its cloud-based image viewer for clinical trials for precise monitoring and supervision. This advanced risk-based monitoring software gives research teams an easy-to-use interface for managing sensitive patient data in a secure online environment. It helps streamline data management processes, improves the accuracy of results, reduces human error, and reaches patients faster and more efficiently. Additionally, it integrates seamlessly into other existing systems to ensure maximum user satisfaction and optimized workflow. With Clario, clinical trial teams worldwide have access to the most up-to-date advancements in risk management software while maintaining maximum security.

                ClinChoice Acquired CROMSOURCE, Expanding its Global Presence

                Clinchoice announced its acquisition of Cromsource, further establishing its presence as a global player in risk-based monitoring software market. Through this process, they have solidified their position in the digital health sector, allowing them to expand their capabilities in delivering effective and customizable solutions to customers worldwide. Clinchoice has taken this step so customers can access the needed resources and remain informed throughout the process. With its international presence, Clinchoice is further advancing data-driven solutions in health care and setting new industry standards.
              Strategy Analysis & Recommendation

              The strategic analysis is essential for organizations seeking a solid foothold in the global marketplace. Companies are better positioned to make informed decisions that align with their long-term aspirations by thoroughly evaluating their current standing in the Risk-based Monitoring Software Market. This critical assessment involves a thorough analysis of the organization’s resources, capabilities, and overall performance to identify its core strengths and areas for improvement.

              Key Company Profiles

              The report delves into recent significant developments in the Risk-based Monitoring Software Market, highlighting leading vendors and their innovative profiles. These include Anju Software, Inc., ArisGlobal LLC, CGI Inc., Change Healthcare LLC, Clario, CluePoints S.A., Dassault Systèmes S.E., DATATRAK International, Inc., DSG, Inc., eClinical Solutions LLC, ICON PLC, Infosys Limited, International Business Machines Corporation, IQVIA Inc., JMP Statistical Discovery LLC, Laboratory Corporation of America Holdings, LexisNexis Risk Solutions Group, MasterControl Solutions Inc., Mednet, Microsoft Corporation, Octalsoft by Glorant, LLC, Oracle Corporation, Parexel International Corporation, Quanticate International Limited, Scrut Automation, Securitas AB, Signant Health, Sphera Solutions, Inc., TATA Consultancy Services Limited, Veeva Systems Inc., and Wipro Limited.

              Market Segmentation & Coverage

              This research report categorizes the Risk-based Monitoring Software Market to forecast the revenues and analyze trends in each of the following sub-markets:
              • Function
                • Centralized Monitoring
                • Reduced Monitoring
                • Remote Monitoring
                • Triggered Monitoring
                • Delivery Mode
                  • Cloud-Based
                  • Licensed Enterprise
                  • Web-Based
                  • End-User
                    • Contract Research Organization
                    • Medical Device Companies
                    • Pharmaceutical & Biopharmaceutical Companies
                    • Region
                      • Americas
                        • Argentina
                        • Brazil
                        • Canada
                        • Mexico
                        • United States
                          • California
                          • Florida
                          • Illinois
                          • New York
                          • Ohio
                          • Pennsylvania
                          • Texas
                          • Asia-Pacific
                            • Australia
                            • China
                            • India
                            • Indonesia
                            • Japan
                            • Malaysia
                            • Philippines
                            • Singapore
                            • South Korea
                            • Taiwan
                            • Thailand
                            • Vietnam
                            • Europe, Middle East & Africa
                              • Denmark
                              • Egypt
                              • Finland
                              • France
                              • Germany
                              • Israel
                              • Italy
                              • Netherlands
                              • Nigeria
                              • Norway
                              • Poland
                              • Qatar
                              • Russia
                              • Saudi Arabia
                              • South Africa
                              • Spain
                              • Sweden
                              • Switzerland
                              • Turkey
                              • United Arab Emirates
                              • United Kingdom


                              Please Note: PDF & Excel + Online Access - 1 Year


1. Preface
1.1. Objectives of the Study
1.2. Market Segmentation & Coverage
1.3. Years Considered for the Study
1.4. Currency & Pricing
1.5. Language
1.6. Stakeholders
2. Research Methodology
2.1. Define: Research Objective
2.2. Determine: Research Design
2.3. Prepare: Research Instrument
2.4. Collect: Data Source
2.5. Analyze: Data Interpretation
2.6. Formulate: Data Verification
2.7. Publish: Research Report
2.8. Repeat: Report Update
3. Executive Summary
4. Market Overview
5. Market Insights
5.1. Market Dynamics
5.1.1. Drivers
5.1.1.1. Need for proactive approach to monitoring clinical trials with the use of risk-based monitoring software
5.1.1.2. Rising number of clinical trials to determine new form of treatment and effectiveness of drugs
5.1.1.3. Government grants and regulatory compliance for the quality and safety of clinical trials
5.1.2. Restraints
5.1.2.1. Complex implementation of the RBM software and organization reluctance to RBM software
5.1.3. Opportunities
5.1.3.1. Technological advancements in risk-based monitoring software
5.1.3.2. Rising trend of outsourcing end-to-end services by pharmaceutical companies
5.1.4. Challenges
5.1.4.1. Data security and privacy concerns associated with RBM software
5.2. Market Segmentation Analysis
5.2.1. Function: Emergence of ​​risk-based monitoring softwares for remote monitoring activities
5.2.2. Delivery Mode: Advancements in cloud-based delivery of risk-based monitoring softwares
5.3. Market Trend Analysis
5.3.1. Ongoing clinical trials and well-established regulatory guidelines to accelerate the use of RBM software in the Americas
5.3.2. Rise in R&D for drug discovery and development and ongoing partnerships to increase availability of RBM software in the APAC region
5.3.3. Robust government support, stringent regulatory standards, and emerging clinical trials propel the RBM software market in the EMEA region.
5.4. Cumulative Impact of Russia-Ukraine Conflict
5.5. Cumulative Impact of High Inflation
5.6. Porter’s Five Forces Analysis
5.6.1. Threat of New Entrants
5.6.2. Threat of Substitutes
5.6.3. Bargaining Power of Customers
5.6.4. Bargaining Power of Suppliers
5.6.5. Industry Rivalry
5.7. Value Chain & Critical Path Analysis
5.8. Regulatory Framework Analysis
5.9. Client Customization
6. Risk-based Monitoring Software Market, by Function
6.1. Introduction
6.2. Centralized Monitoring
6.3. Reduced Monitoring
6.4. Remote Monitoring
6.5. Triggered Monitoring
7. Risk-based Monitoring Software Market, by Delivery Mode
7.1. Introduction
7.2. Cloud-Based
7.3. Licensed Enterprise
7.4. Web-Based
8. Risk-based Monitoring Software Market, by End-User
8.1. Introduction
8.2. Contract Research Organization
8.3. Medical Device Companies
8.4. Pharmaceutical & Biopharmaceutical Companies
9. Americas Risk-based Monitoring Software Market
9.1. Introduction
9.2. Argentina
9.3. Brazil
9.4. Canada
9.5. Mexico
9.6. United States
10. Asia-Pacific Risk-based Monitoring Software Market
10.1. Introduction
10.2. Australia
10.3. China
10.4. India
10.5. Indonesia
10.6. Japan
10.7. Malaysia
10.8. Philippines
10.9. Singapore
10.10. South Korea
10.11. Taiwan
10.12. Thailand
10.13. Vietnam
11. Europe, Middle East & Africa Risk-based Monitoring Software Market
11.1. Introduction
11.2. Denmark
11.3. Egypt
11.4. Finland
11.5. France
11.6. Germany
11.7. Israel
11.8. Italy
11.9. Netherlands
11.10. Nigeria
11.11. Norway
11.12. Poland
11.13. Qatar
11.14. Russia
11.15. Saudi Arabia
11.16. South Africa
11.17. Spain
11.18. Sweden
11.19. Switzerland
11.20. Turkey
11.21. United Arab Emirates
11.22. United Kingdom
12. Competitive Landscape
12.1. Market Share Analysis, 2023
12.2. FPNV Positioning Matrix, 2023
12.3. Competitive Scenario Analysis
12.3.1. Cloudbyz Unveiled Groundbreaking Electronic Data Capture Solution to Streamline Clinical Research and Accelerate Launch of New Therapies
12.3.2. Clario Launched Cloud-Based Image Viewer for Clinical Trials
12.3.3. ClinChoice Acquired CROMSOURCE, Expanding its Global Presence
12.3.4. Scrut Automation Raised USD 7.5 Million From Massmutual Ventures
12.3.5. EMA launched a pilot project on analysis of raw data from clinical trials
12.3.6. Q² Solutions Launched Innovative Self-Collection Safety Lab Panel in Collaboration With Tasso
12.3.7. Medidata Announced Rapid Expansion of its Sensor Cloud Network with the Addition of 10 Health Technology Innovators
12.3.8. Medidata Launches New Clinical Operations Technologies to Address Critical Issues in Clinical Trial Oversight
12.3.9. Novotech and Medidata expanded partnership to continue advancements in clinical research
12.3.10. Veeva Vault CTMS Enabled Proactive Clinical Trial Management for More than 150 Companies
12.3.11. TCS launches risk-based monitoring solution
12.3.12. Thread and Amazon Web Services Modernized Clinical Research with Launch of Cloud-based, AI-driven Decentralized Clinical Trials Technology
13. Competitive Portfolio
13.1. Key Company Profiles
13.2. Key Product Portfolio

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