Product Overview

Risk-based monitoring software provides clinical teams with a single platform that transforms numerous study data streams into actionable analytics. The result is a more focused and data driven monitoring effort that enables sponsor oversight and improves the quality and compliance of a clinical trial or program.

Market Highlights

Risk-based Monitoring Software Market is expected to project a notable CAGR of 13.6% in 2030.

Risk-based Monitoring Software Market to surpass USD 593 Million by 2030 from USD 268 Million in 2019 at a CAGR of 13.6% throughout the forecast period, i.e., 2020-30. The main factors driving the risk-based monitoring software market are increasing the reliability and expense of risk-based monitoring solutions and increasing governments' investment in supporting clinical trials due to increasing demand. Major market players are focused on releasing revised versions of risk-based monitoring software that are expected to boost the demand for risk-based monitoring software in pharmaceutical and biopharmaceutical companies.

Risk-based Monitoring Software Market: Segments

Software segment to grow with the highest CAGR during 2020-30

Risk-based Monitoring Software Market is segmented by component into software and services. The greater market share in 2019 was accounted by software segment of the global risk-based monitoring software. The R&D expenditure in the life sciences and clinical research industries, the rising number of clinical trials, and the increasing customer base can be attributed to the large share of this market. It is anticipated that the segment will be powered by a rise in the number of clinical trials, client base, and R&D spending in the life sciences and clinical research industries.

Medical device companies Segments to grow with the highest CAGR during 2020-30

Risk-based Monitoring Software Market is segmented by End-User into pharmaceutical and biopharmaceutical companies, CROs, medical device companies, and others. Based on End-User, pharmaceutical and biopharmaceutical companies segment dominated the market and it is expected to register the highest CAGR in this market during the forecast period. The growing R&D spending of pharmaceutical and biopharmaceutical companies is the key driver of this end-user segment's growth.

Risk-based Monitoring Software Market: Market Dynamics

Drivers

Growing investments by governments to support clinical trials

Main factors driving the risk-based monitoring software market are increasing the reliability and expense of risk-based monitoring solutions and increasing governments' investment in supporting clinical trials due to increasing demand. Major market players are focused on the launch of updated versions of risk-based monitoring software, which is expected to fuel the demand for risk-based monitoring software in pharmaceutical and biopharmaceutical companies, medical device companies, and CROs. Bioclinica, for example, introduced the SMART technology suite available in 2019, together with Medical Imaging, Electronic Data Capture (EDC) and Interactive Response Technology (IRT).

Growing adoption of EHRs and other HCIT solutions

Information about patients is confusing, private, and sometimes unstructured. It is a challenge to merge this knowledge into the delivery process of healthcare, which must be met in order to realize opportunities to improve patient care. While EHRs have been in use for more than a decade, because of government measures in different countries to enhance patient safety, the market has picked up momentum in recent years. The growing number of accountable care organizations that have also contributed to demand is another important factor in the country.

Restrain

High cost related with Risk-based Monitoring Software

There is a considerably high cost of implementation of risk-based monitoring solutions and interoperability solutions for various medical devices. It is a major challenge for healthcare organizations to resolve such financial constraints, especially in emerging economies where budgetary approvals for IT solutions over medical equipment are usually difficult to obtain. Smaller healthcare entities are struggling to integrate Internet access to medical devices, largely because of challenges in integrating multiple health networks, the absence of wireless connectivity solutions, and the need to add security layers to prevent data breaches. In addition, the infrastructural costs of implementing and connecting an EHR system to various devices with separate interfaces constitute a major barrier to market growth in emerging regions.

Risk-based Monitoring Software Market: Key Players

Medidata Solutions

Company Overview, Business Strategy, Key Product Offerings, Financial Performance, Key Performance Indicators, Risk Analysis, Recent Development, Regional Presence and SWOT Analysis.

Parexel

Bioclinica

Bio-Optronics

IBM Corporation

DATATRAK

Veeva Systems

DSG

MasterControl

Risk-based Monitoring Software Market: Regions

Risk-based Monitoring Software Market is segmented based on regional analysis into five major regions. These include North America, Latin America, Europe, APAC and MENA.

Risk-based Monitoring Software Market in North America held the largest market share of XX.X% in the year 2019 and is expected to continue its stronghold for a few more years. In the forecast era, the Asia Pacific market is projected to expand at the highest CAGR. This growth can be attributed to increased government funding to support clinical trials, the presence of less strict regulatory standards relative to developed countries, a broad patient population, low operational costs for clinical trials, the lack of volunteer trials in Europe and North America, and the region's growing number of pharmaceutical companies and CROs.

Competitive Landscape:

The Risk-based Monitoring Software market, which is highly competitive, consists of several major players such as Oracle (US), Medidata Solutions (US), and Parexel (US) hold a substantial market share in the Risk-based Monitoring Software market. Other players analyzed in this report are Bioclinica (US), Bio-Optronics (US), IBM Corporation (US), DATATRAK (US), Veeva Systems (US), DSG (US), MasterControl (US), ERT (US), Forte Research Systems (US), MedNet Solutions (US), ArisGlobal (US), Anju Software (US), MaxisIT (US), Techsol Corporation (US), OpenClinica (US), CRF Health (US), and Covance (US) among others.

The market competition has been stepped up by the availability of many players offering Risk-based Monitoring Software. For Instance, in 2019, Bioclinica (US) launched the SMART technology suite available with Medical Imaging, Electronic Data Capture (EDC), and Interactive Response Technology (IRT) combined.

Risk-based Monitoring Software Market is further segmented by region into:

North America Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – United States and Canada

Latin America Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – Mexico, Argentina, Brazil and Rest of Latin America

Europe Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – United Kingdom, France, Germany, Italy, Spain, Belgium, Hungary, Luxembourg, Netherlands, Poland, NORDIC, Russia, Turkey and Rest of Europe

APAC Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – India, China, South Korea, Japan, Malaysia, Indonesia, New Zealand, Australia and Rest of APAC

MENA Market Size, Share, Trends, Opportunities, Y-o-Y Growth, CAGR – North Africa, Israel, GCC, South Africa and Rest of MENA

Risk-based Monitoring Software Market report also contains analysis on:

Risk-based Monitoring Software Market Segments:

By Component:

Software

Services

By Delivery Mode:

Web-based

Licensed Enterprise

Cloud-based

By End-User:

Pharmaceutical & Biopharmaceutical Companies

CROs

Medical Device Companies

Other

Risk-based Monitoring Software Market Dynamics

Risk-based Monitoring Software Market Size

Supply & Demand

Current Trends/Issues/Challenges

Competition & Companies Involved in the Market

Value Chain of the Market

Market Drivers and Restraints

Contents

1. Executive Summary

2. Risk-based Monitoring Software Market

2.1. Product Overview

2.2. Market Definition

2.3. Segmentation

2.4. Assumptions and Acronyms

3. Research Methodology

3.1. Research Objectives

3.2. Primary Research

3.3. Secondary Research

3.4. Forecast Model

3.5. Market Size Estimation

4. Average Pricing Analysis

5. Macro-Economic Indicators

6. Market Dynamics

6.1. Growth Drivers

6.2. Restraints

6.3. Opportunity

6.4. Trends

7. Correlation & Regression Analysis

7.1. Correlation Matrix

7.2. Regression Matrix

8. Recent Development, Policies & Regulatory Landscape

9. Risk Analysis

9.1. Demand Risk Analysis

9.2. Supply Risk Analysis

10. Risk-based Monitoring Software Analysis

10.1. Porters Five Forces

10.1.1. Threat of New Entrants

10.1.2. Bargaining Power of Suppliers

10.1.3. Threat of Substitutes

10.1.4. Rivalry

10.2. PEST Analysis

10.2.1. Political

10.2.2. Economic

10.2.3. Social

10.2.4. Technological

11. Risk-based Monitoring Software Market

11.1. Market Size & forecast, 2019A-2030F

11.1.1. By Value (USD Million) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

11.1.2. By Volume (Million Units) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

12. Risk-based Monitoring Software: Market Segmentation

12.1. By Regions

12.1.1. North America:

• By Value (USD Million) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

12.1.2. Europe:

• By Value (USD Million) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

12.1.3. Asia-Pacific:

• By Value (USD Million) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

12.1.4. MEA:

• By Value (USD Million) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

12.1.5. Latin America:

• By Value (USD Million) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

12.2. By Component: Market Share (2020-2030F)

12.2.1. Software, By Value (USD Million) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

12.2.2. Services, By Value (USD Million) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

12.3 By End-User: Market Share (2020-2030F)

12.3.1. Pharmaceutical & Biopharmaceutical Companies, By Value (USD Million) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

12.3.2. CROs, By Value (USD Million) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

12.3.3. Medical Device Companies, By Value (USD Million) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

12.3.4. Others, By Value (USD Million) 2019-2030F; Y-o-Y Growth (%) 2020-2030F

13. Company Profile

13.1.1. Medidata Solutions.

13.1.2. Company Overview

13.1.3. Company Total Revenue (Financials)

13.1.4. Market Potential

13.1.5. Global Presence

13.1.6. Key Performance Indicators

13.1.7. SWOT Analysis

13.1.8. Product Launch

13.2. Parexel

13.3. Bioclinica

13.4. Bio-Optronics

13.5. IBM Corporation

13.6. DATATRAK

13.7. Veeva Systems

13.8. DSG

13.9. Master Control

14 Consultant Recommendation

**The above given segmentations and companies could be subjected to further modification based on in-depth feasibility studies conducted for the final deliverable.

Methodology/Research Approach

This research study involved the extensive usage of both primary and secondary data sources. The research process involved the study of various factors affecting the industry, including the government policy, market environment, competitive landscape, historical data, present trends in the market, technological innovation, upcoming technologies and the technical progress in related industry, and market risks, opportunities, market barriers and challenges. The following illustrative figure shows the market research methodology applied in this report.

Research Programs/Design

Historical Data (2015-2019)	Industry Trends Competitive Landscape By Company Expansion Mergers and Acquisitions Market Segment by Type by Application By Regions/ Geography	Value Status and Outlook Value for Major Players Market Share Growth Rate Present Situation Analysis Value Market Share Growth Rate Present Situation Analysis
Influencing Factors	Market Environment Government Policy Technological Changes Market Risks	Market Drivers Growing Demand of Downstream Reduction in Cost
Market Forecast (2021-2026)	Overall Size by Type by Application By Regions/Geography	Key Data (Value) Market Share Growth Rate CAGR (2021-2026)

Market Size Estimation

Top-down and bottom-up approaches are used to validate the global Voluntary Carbon Offset market size market and estimate the market size for Company, regions segments, product segments and Application (end users).

The market estimations in this report are based on the marketed sale price of Voluntary Carbon Offset (excluding any discounts provided by the player, distributor, wholesaler or traders). The percentage splits, market share, and breakdowns of the product segments are derived on the basis of weights assigned to each of the segments on the basis of their utilization rate and average sale price. The regional splits of the overall Voluntary Carbon Offset market and its sub-segments are based on the percentage adoption or utilization of the given product in the respective region or country.

Major Company in the market is identified through secondary research and their market revenues determined through primary and secondary research. Secondary research included the research of the annual and financial reports of the top Company; whereas, primary research included extensive interviews of key opinion leaders and industry experts such as experienced front-line staff, directors, CEOs and marketing executives. The percentage splits, market share, Growth Rate and breakdowns of the product markets are determined through using secondary sources and verified through the primary sources.

All possible factors that influence the markets included in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data. The market size for top-level markets and sub-segments is normalized, and the effect of inflation, economic downturns, and regulatory & policy changes or other factors are not accounted for in the market forecast. This data is combined and added with detailed inputs and analysis from Market Intellix and presented in this report

The following figure shows an illustrative representation of the overall market size estimation process used for this study.

Market Breakdown and Data Triangulation

After complete market engineering with calculations for market statistics; market size estimations; market forecasting; market breakdown; and data triangulation, extensive primary research was conducted to gather information and verify and validate the critical numbers arrived at. In the complete market engineering process, both top-down and bottom-up approaches were extensively used, along with several data triangulation methods, to perform market estimation and market forecasting for the overall market segments and sub-segments listed in this report. Extensive qualitative and further quantitative analysis is also done from all the numbers arrived at in the complete market engineering process to list key information throughout the report.

Data Source

Secondary Sources

Secondary sources include such as press releases, annual reports, non-profit organizations, industry associations, governmental agencies and customs data, etc. This research study involves the usage of widespread secondary sources, directories, databases such as Bloomberg Business, Wind Info, Hoovers, Factiva (Dow Jones & Company), and TRADING ECONOMICS, and News Network, statista, Federal Reserve Economic Data, annual reports, BIS Statistics, ICIS; company house documents; CAS(American Chemical Society); investor presentations; and SEC filings of companies. Secondary research was used to identify and collect information useful for the extensive, technical, market-oriented, and Hospitals study of the Voluntary Carbon Offset market. It was also used to obtain important information about the top companies, market classification and segmentation according to industry trends to the bottom-most level, and key developments related to market and technology perspectives.

Market Size	Segmental value Geographic Penetration Product Adoption Rate for Different market	Journals, Websites, and Press Releases Annual Reports and SEC Filings Company Websites and Press Releases Public and Paid Databases Market Intellix Data Repository
Market Position of Top Company	Product Financials Geographic value Mix Total Company value Business/Segmental value Mix
Qualitative Analysis	Influence Factors Market Potential Market Risks and Opportunities Industry Trends Geographical Features Government Policies	Company Websites and Press Releases Public and Paid Databases Annual Reports Industry Associations Market Intellix Data Repository

Primary Sources

In the primary research process, various sources from both the supply and demand sides were interviewed to obtain qualitative and quantitative information for this report. The primary sources from the supply side include product Company (and their competitors), opinion leaders, industry experts, research institutions, distributors, dealer and traders, as well as the raw materials suppliers and producers, etc.

The primary sources from the demand side include industry experts such as business leaders, marketing and sales directors, technology and innovation directors, supply chain executive, end use (product buyers), and related key executives from various key companies and organizations operating in the global market.

Primary research was conducted to identify segmentation Type, product price range, product Application, key Company, raw materials supply and the downstream demand, industry status and outlook, and key market dynamics such as risks, influence factors, opportunities, market barriers, industry trends, and key player strategies.

Key Executives Interviewed

Key Data Information from Primary Sources

Primary Sources	Parameters	Key Data
Market Segments(by Application, by Type)	Value by Type Status and Forecast Value by Application Value by Regions, Status and Forecast (2021-2026)	Value Market Share by Type Value Growth Rate by Type Value by Application Percentage and Growth Rate by Application Value Growth Rate and Market Share by Regions Market Size Status and Forecast (2021-2026)
Total Market	Overall Size, Status and Forecast	Market Size Status and Forecast (2021-2026)