Summary

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

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