[196 Pages Report] 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.
Function: Emergence of ??risk-based monitoring softwares for remote monitoring activities
Centralized monitoring entails systematically monitoring clinical trial data and processes from a central location. Centralized monitoring is crucial for enhancing data quality and ensuring trial integrity without the necessity of on-site visits. Reduced monitoring refers to minimizing traditional on-site monitoring visits and activities, focusing instead on critical data and processes that directly impact trial quality and patient safety. Remote monitoring allows CRAs (Clinical Research Associates) to perform their monitoring activities off-site, utilizing electronic means to review trial data and communicate with trial sites. Triggered monitoring is an adaptive approach where efforts are intensified based on specific triggers or indicators of risk identified through data analytics.
Delivery Mode: Advancements in cloud-based delivery of risk-based monitoring softwares
Cloud-based RBM software is delivered over the internet and stored on the provider’s servers. The cloud-based RBM model offers high flexibility, scalability, and cost efficiency, making it particularly suitable for small to medium-sized enterprises (SMEs) or organizations with limited IT infrastructure. Licensed enterprise RBM software is installed and hosted on the customer’s own servers. Licensed enterprise RBM software delivery mode is preferred by large organizations seeking full control over their software and data. Licensed enterprise RBM software allows for extensive customization and integration with existing systems, suiting organizations with complex monitoring needs and substantial IT support. Web-based RBM software is accessible through a web browser without software installations. This type of delivery is particularly advantageous for organizations seeking ease of access and use, minimal IT involvement, and fast deployment.
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.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Risk-based Monitoring Software Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis 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: 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 examination of the current state of vendors in the Risk-based Monitoring Software Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. 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 this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
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 Syst?mes 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
- Americas
The report offers valuable insights on the following aspects:
- Market Penetration: It presents comprehensive information on the market provided by key players.
- Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
- Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
- Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
- Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
The report addresses key questions such as:
- What is the market size and forecast of the Risk-based Monitoring Software Market?
- Which products, segments, applications, and areas should one consider investing in over the forecast period in the Risk-based Monitoring Software Market?
- What are the technology trends and regulatory frameworks in the Risk-based Monitoring Software Market?
- What is the market share of the leading vendors in the Risk-based Monitoring Software Market?
- Which modes and strategic moves are suitable for entering the Risk-based Monitoring Software Market?
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