Global Clinical Trial Management System Market, By Mode of Delivery (Cloud-based, On-premise), Offering (Software, Services), End User (Healthcare Companies, CRO, Medical Device Companies, Others (Research Institutes, Hospitals, etc.)), and Geography - Insights, Size, Share, Opportunity Analysis, and Industry Forecast till 2025

Clinical Trial Management Systems – Increasing Number of Clinical Trials Leading To the Growth of Clinical Trial Management Systems Market

The Clinical Trial Management System (clinical trial management systems) is an integrated software designed to manage the clinical trial data system used by biotech and pharma companies, it provides customizable functions with advanced technology and tools, which help reduce time and cost during clinical trial by helping to manage large and complex clinical trial data. Also, clinical trial management systems provides various benefits such as easy access to data from various client locations, sharing of information function, data maintenance and security, avoids complexity of administration and helps to manage clinical trials conducted at various locations by providing access to more than one user simultaneously.

According to ClinicalTrials.gov, as of May 2017, 36% clinical trials out of the globe are conducted in United States and 245,188 studies are registered with ClinicalTrials.gov. Furthermore, according to the study conducted by University of Minnesota and University of Michigan by 2018, all the clinical trial conducting company will use OnCore clinical trial management system as OnCore will provide the functional features such as Clinical Research Management, Study Setup, eCRFs, Financials, Visit Tracking & Data Capture, Study Data Management and Revenue Management.

There are two type of clinical trial management systems available and are categorized on the basis of mode of delivery- Cloud based clinical trial management systems and On-premise clinical trial management systems. The Cloud-based/web-based are among the most widely used clinical trial management systems solutions, as it allows for high customization as per requirement, faster turnaround time, and low costs as compared to on-premise clinical trial management systems solutions. Increasing security concerns related to clinical trials data drive companies, especially those focusing on patenting products, also some companies need customization according to their business need, in this cases those companies opt for on-premise clinical trial management systems.

High awareness about the technology for clinical trial management driving the growth of clinical trial management systems market in developed regions

Developed economies such as the U.S., Canada, Germany, Italy, U.K., Australia, Japan and France have well established infrastructure that can support new technologies and being the leading pharmaceutical markets globally, these economies are well backed with funds for improving process efficiencies. As, most major players in the industry are based in North America and Europe they make clinical trial management systems system easily available to clients.

The global clinical trial management systems market was valued at US$ 578.6 million in 2016 and is expected to witness a robust CAGR of 13.0% during the forecast period (2017 – 2025).

Figure: Global Clinical Trial Management System Market, By Region, 2016-2025

clinical trial management systems market

Source: Coherent Market Insights

Pharmaceuticals manufacturers focusing on achieving first mover advantage is expected to be one of the primary factor for the growth of clinical trial management systems market over the forecast period

The pharmaceuticals sector is highly competitive, with companies vying to achieve first mover advantage, in turn making clinical trials a crucial element. Thus, major players in the market are focusing on integrating clinical trial management systems. The last couple of decades have witnessed robust growth in trade and commerce, with companies across sectors no longer inhibited by physical boundaries. This has enabled companies, including pharmaceuticals manufacturers to tap in to diverse geographical markets in order to increase their consumer base and in turn exponentially increase profits.

The clinical trials helps companies overcome regulatory barriers for drug approval, as they are not restricted to just one market, to conduct trials for rare diseases at diverse locations provides results from humans with different genetic structure, in turn enabling a more complete and effective solution catering to diverse patient population.

Contract research organizations (CROs) in emerging economies expected to fuel the growth in clinical trial management systems market

Emerging economies such as India, Brazil, Argentina, and Iran, still lack adequate infrastructure for clinical trials therefore the outsourcing for clinical trials management systems is preferable way to conduct clinical trials in emerging countries. As companies focus on core aspects such as product development and laying major emphasis on reducing costs, this has led to emergence of various CROs especially in Asia Pacific region.

However, companies, especially in unindustrialized economies are still inclined towards use of rudimentary tools such as spreadsheets for database management, mainly due to lack of awareness about clinical trial management systems and also cost concerns is the growth restraining factor in clinical trial management systems market.

Some of the major companies offering clinical trial management systems are Oracle Corporation, Medidata Clinical Cloud, Veeva Systems, Infosys, Bio-Optronics, BioClinica, and MedNet Solutions.

The software and tools used to manage clinical trials are known as clinical trial management systems (CTMS). CTMS help reduce expenditure of time and money with respect to improved study by providing different benefits such as secure real time access of data from multiple locations. There are two types of CTMS, namely, cloud-based clinical trial management systems and on-premise clinical trial management systems.

Cloud-based CTMS offer 24x7 access, data administration, data security, data access from various client locations, sharing of information and technical support with advanced tools and trained staff. However, on-premise CTMS provides more security of data as it is stored and maintained at on site or at client location. Also, on-premise CTMS provides customization in software as per business needs, control on software upgrades and it is easy to share clinical trials data in house if in case lack of internet connectivity across locations.

As on-premise CTMS needs software to be purchased outright and is relatively capital intensive. However, due to rising data security issue related with cloud-based CTMS, some companies prefer on-premise CTMS.

Market Dynamics

Increasing number of clinical trials and globalization of R&D is fueling growth of CTMS market, especially in developed regions. Furthermore, rising demand for CTMS to manage multiple and complex data of clinical trials will support the growth of CTMS market in the near future.

The pharmaceuticals sector is highly competitive and companies are focusing on emerging economies to increase consumer base and profit which resulting in increased demand for CTMS, as CTMS helps companies to overcome regulatory barriers for drug approval across the globe. As the cost requirement is relatively very low to conduct clinical trial in emerging markets than developed markets, therefore the companies are focusing on Asia Pacific region which in turn result in high growth of CTMS market in near the future.

Also, companies are approaching to CRO’s as emerging countries lack appropriate infrastructure to conduct clinical trials which, may result in the growth of CTMS market in this region. The North America holds the major market share of CTMS market as the healthcare research organizations and CRO’s in this region are early adopters of CTMS solutions, which is supported by high awareness about CTMS solution among them.

Market Taxonomy

This report segments the global clinical trial management system market on the basis of mode of delivery, offering, end user, and geography. On the basis of mode of delivery, the market is categorized into Cloud-based and On-premise. Among these mode of delivery market cloud-based segment dominate the clinical trial management system market. On the basis of offering, the market is divided into software and services. On the basis of end user, the market is divided into healthcare companies, CRO, medical device companies and others (Research Institutes, Hospitals, etc.). Among all end users, healthcare companies segment dominated the clinical trial management system market, as healthcare companies are highly competitive, vying to achieve first mover advantage.

Key features of the study:

  • This report provides in-depth analysis of the clinical trial management systems market and provides market size (US$ Mn) and Cumulative Annual Growth Rate (CAGR) (%) for the forecast period (2017–2025)
  • It elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for this market. It provides valuable insights about market drivers, restraints, opportunities, new product launches or approval, pipeline drugs, regional outlook, and competitive strategy adopted by the leading players
  • It profiles leading players in the global clinical trial management systems market based on the following parameters – company overview, financial performance, product portfolio, geographical presence, key developments, and future plans
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions with respect to their future product launch, market expansion, and marketing tactics
  • The global clinical trial management systems market report caters to various stakeholders in this industry, including investors, product developers, distributors, healthcare companies, research institutes, CROs, medical device companies, new entrants, and financial analysts
  • Stakeholders would greatly benefit in decision making through the various strategy matrices used in analyzing the clinical trial management systems market

Detailed Segmentation:

  • Global Clinical Trial management System Market, By Mode of Delivery:
    • Cloud-based
    • On-premise
  • Global Clinical Trial management System Market, By Offering:
    • Software
    • Services
  • Global Clinical Trial management System Market, By End User:
    • Healthcare Companies
    • CRO
    • Medical Device Companies
    • Others (Research Institutes, Hospitals, etc.)
  • Global Clinical Trial management System Market, By Geography:
    • North America
      • North America Clinical Trial management System Market, By Mode of Delivery:
        • Cloud-based
        • On-premise
      • North America Clinical Trial management System Market, By Offering:
        • Software
        • Services
      • North America Clinical Trial management System Market, By End User:
        • Healthcare Companies
        • CRO
        • Medical Device Companies
        • Others (Research Institutes, Hospitals, etc.)
      • North America Clinical Trial management System Market, By Country:
        • U.S.
        • Canada
    • Europe
      • Europe Clinical Trial management System Market, By Mode of Delivery:
        • Cloud-based
        • On-premise
      • Europe Clinical Trial management System Market, By Offering:
        • Software
        • Services
      • Europe Clinical Trial management System Market, By End User:
        • Healthcare Companies
        • CRO
        • Medical Device Companies
        • Others (Research Institutes, Hospitals, etc.)
      • Europe Clinical Trial management System Market, By Country:
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia-Pacific
      • Asia-Pacific Clinical Trial management System Market, By Mode of Delivery:
        • Cloud-based
        • On-premise
      • Asia-Pacific Clinical Trial management System Market, By Offering:
        • Software
        • Services
      • Asia-Pacific Clinical Trial management System Market, By End User:
        • Healthcare Companies
        • CRO
        • Medical Device Companies
        • Others (Research Institutes, Hospitals, etc.)
      • Asia-Pacific Clinical Trial management System Market, By Country:
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia-Pacific
    • Latin America
      • Latin America Clinical Trial management System Market, By Mode of Delivery:
        • Cloud-based
        • On-premise
      • Latin America Clinical Trial management System Market, By Offering:
        • Software
        • Services
      • Latin America Clinical Trial management System Market, By End User:
        • Healthcare Companies
        • CRO
        • Medical Device Companies
        • Others (Research Institutes, Hospitals, etc.)
      • Latin America Clinical Trial management System Market, By Country:
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Middle East
      • Middle East Clinical Trial management System Market, By Mode of Delivery:
        • Cloud-based
        • On-premise
      • Middle East Clinical Trial management System Market, By Offering:
        • Software
        • Services
      • Middle East Clinical Trial management System Market, By End User:
        • Healthcare Companies
        • CRO
        • Medical Device Companies
        • Others (Research Institutes, Hospitals, etc.)
      • Middle East Clinical Trial management System Market, By Country:
        • GCC
        • Israel
        • Rest of Middle-East
    • Africa
      • Africa Clinical Trial management System Market, By Mode of Delivery:
        • Cloud-based
        • On-premise
      • Africa Clinical Trial management System Market, By Offering:
        • Software
        • Services
      • Africa Clinical Trial management System Market, By End User:
        • Healthcare Companies
        • CRO
        • Medical Device Companies
        • Others (Research Institutes, Hospitals, etc.)
      • Africa Clinical Trial management System Market, By Country:
        • North Africa
        • Central Africa
        • South Africa
  • Company Profiles
    • Medidata Solutions Inc. *
      • Company Overview
      • Product Portfolio
      • Market Presence
      • Financial Overview
      • Key Developments
      • Strategies
    • OpenClinica LLC
    • Forte Research Systems, Inc.
    • Oracle Corporation
    • Datatrak International, Inc.
    • Medrio, Inc.
    • Parexel International Corporation
    • Bioclinica
    • Veeva Systems
    • Crucial Life Sciences Data Solutions Inc.

“*” marked represents similar segmentation in other categories in the respective section.

Table of Contents

  1. Research Objective and assumption
    • Research Objectives
    • Assumptions
    • Abbreviations
  2. Market Purview
    • Report Description
      • Market Definition and Scope
    • Executive Summary
      • Market Snippet By Mode of Delivery
      • Market Snippet By Offering
      • Market Snippet By End User
      • Market Snippet By Region
    • Coherent Opportunity Map (COM)
  3. Market Dynamics, Regulations, and Trends Analysis
    • Market Dynamics
      • Drivers
      • Restraints & Challenges
      • Market Opportunities
      • Merger and Acquisitions
      • Key to a Successful CTMS Solution
  4. Global Clinical Trial management System Market, By Mode of Delivery, 2016 - 2025 (US$ Million)
    • Introduction
      • Market Share Analysis, 2017 and 2025 (%)
      • Y-O-Y Growth Analysis, 2015 - 2025
      • Segment Trends
    • Cloud-based
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (US$ Million)
    • On-premise
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (US$ Million)
  5. Global Clinical Trial management System Market, By Offering, 2016 - 2025 (US$ Million)
    • Introduction
      • Market Share Analysis, 2017 and 2025 (%)
      • Y-O-Y Growth Analysis, 2015 - 2025
      • Segment Trends
    • Software
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (US$ Million)
    • Services
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (US$ Million)
  6. Global Clinical Trial management System Market, By End User, 2016 - 2025 (US$ Million)
    • Introduction
      • Market Share Analysis, By Region, 2015 and 2025 (%)
      • Y-O-Y Growth Analysis, For Regions, 2015 – 2025
      • Segment Trends
    • Healthcare Companies
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (US$ Million)
    • CRO
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (US$ Million)
    • Medical Device Companies
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (US$ Million)
    • Others (Research Institutes, Hospitals, etc.)
      • Introduction
      • Market Size and Forecast, and Y-O-Y Growth, 2015 - 2025, (US$ Million)
  7. Global Clinical Trial management System Market, By Region, 2016 - 2025 (US$ Million)
    • Introduction
      • Market Share Analysis, By Region, 2015 and 2025 (%)
      • Y-O-Y Growth Analysis, For Regions, 2015 – 2025
      • Regional Trends
    • North America
      • Market Share Analysis, By Country, 2015 and 2025 (%)
      • Y-O-Y Growth Analysis, By Country, 2015 – 2025
      • Market Size and Forecast, By Mode of Delivery, 2015-2025
      • Market Size and Forecast, By Offering, 2015-2025
      • Market Size and Forecast, By End User, 2015-2025
      • Market Size and Forecast, By Country, 2015-2025
    • Europe
      • Market Share Analysis, By Country, 2015 and 2025 (%)
      • Y-O-Y Growth Analysis, By Country, 2015 – 2025
      • Market Size and Forecast, By Mode of Delivery, 2015-2025
      • Market Size and Forecast, By Offering, 2015-2025
      • Market Size and Forecast, By End User, 2015-2025
      • Market Size and Forecast, By Country, 2015-2025
    • Asia Pacific
      • Market Share Analysis, By Country, 2015 and 2025 (%)
      • Y-O-Y Growth Analysis, By Country, 2015 – 2025
      • Market Size and Forecast, By Mode of Delivery, 2015-2025
      • Market Size and Forecast, By Offering, 2015-2025
      • Market Size and Forecast, By End User, 2015-2025
      • Market Size and Forecast, By Country, 2015-2025
    • Latin America
      • Market Share Analysis, By Country, 2015 and 2025 (%)
      • Y-O-Y Growth Analysis, By Country, 2015 – 2025
      • Market Size and Forecast, By Mode of Delivery, 2015-2025
      • Market Size and Forecast, By Offering, 2015-2025
      • Market Size and Forecast, By End User, 2015-2025
      • Market Size and Forecast, By Country, 2015-2025
    • Middle East
      • Market Share Analysis, By Country, 2015 and 2025 (%)
      • Y-O-Y Growth Analysis, By Country, 2015 – 2025
      • Market Size and Forecast, By Mode of Delivery, 2015-2025
      • Market Size and Forecast, By Offering, 2015-2025
      • Market Size and Forecast, By End User, 2015-2025
      • Market Size and Forecast, By Country, 2015-2025
    • Africa
      • Market Share Analysis, By Country, 2015 and 2025 (%)
      • Y-O-Y Growth Analysis, By Country, 2015 – 2025
      • Market Size and Forecast, By Mode of Delivery, 2015-2025
      • Market Size and Forecast, By Offering, 2015-2025
      • Market Size and Forecast, By End User, 2015-2025
      • Market Size and Forecast, By Country, 2015-2025
  8. Competitive Landscape
    • Heat Map Analysis
    • Market Share Analysis
    • Company Profiles
      • Medidata Solutions Inc.
        • Company Overview
        • Product Portfolio
        • Market Presence
        • Financial Overview
        • Key Developments
        • Strategies
      • OpenClinica LLC
        • Company Overview
        • Product Portfolio
        • Market Presence
        • Financial Overview
        • Key Developments
        • Strategies
      • Forte Research Systems, Inc.
        • Company Overview
        • Product Portfolio
        • Market Presence
        • Financial Overview
        • Key Developments
        • Strategies
      • Oracle Corporation
        • Company Overview
        • Product Portfolio
        • Market Presence
        • Financial Overview
        • Key Developments
        • Strategies
      • Datatrak International, Inc.
        • Company Overview
        • Product Portfolio
        • Market Presence
        • Financial Overview
        • Key Developments
        • Strategies
      • Medrio, Inc.
        • Company Overview
        • Product Portfolio
        • Market Presence
        • Financial Overview
        • Key Developments
        • Strategies
      • Parexel International Corporation
        • Company Overview
        • Product Portfolio
        • Market Presence
        • Financial Overview
        • Key Developments
        • Strategies
      • Bioclinica
        • Company Overview
        • Product Portfolio
        • Market Presence
        • Financial Overview
        • Key Developments
        • Strategies
      • Veeva Systems
        • Company Overview
        • Product Portfolio
        • Market Presence
        • Financial Overview
        • Key Developments
        • Strategies
      • Crucial Life Sciences Data Solutions Inc.
        • Company Overview
        • Product Portfolio
        • Market Presence
        • Financial Overview
        • Key Developments
        • Strategies
    • Analyst Views
  9. Section
    • Research Methodology
    • About us and Services

*Browse 35 market data tables and 18 figures on "Clinical Trial management System Market - Global forecast to 2025”.  

Research Methodology

Coherent Market Insights followsa comprehensive research methodology focused on providing the most precise market analysis. The company leverages a data triangulation model which helps company to gauge the market dynamics and provide accurate estimates. Key components of the research methodologies followed for all our market reports include:

  • Primary Research (Trade Surveys and Experts Interviews)
  • Desk Research
  • Proprietor Data Analytics Model

In addition to this, Coherent Market Insights has access to a wide range of the regional and global reputed paid data bases, which helps the company to figure out the regional and global market trends and dynamics. The company analyses the industry from the 360 Degree Perspective i.e. from the Supply Side and Demand Side which enables us to provide granular details of the entire ecosystem for each study. Finally, a Top-Down approach and Bottom-Up approach is followed to arrive at ultimate research findings.


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Coherent Market Insights desk research is based on a principle set of research techniques:

  • National level desk research: It Includes research analysis of regional players, regional regulatory bodies, regional trade associations, and regional organization.
  • Multinational level desk research: The research team keeps a track of multinational players, global regulatory bodies, global trade associations, and global organization.

Coherent Market Insights has a large amount of in-house repository of industry database. This is leveraged as a burner for initiating a new research study. Key secondary sources include:

  • Governmental bodies, National and international social welfare institutions, and organizations creating economic policies among others.
  • Trade association, National and international media and trade press.
  • Company Annual reports, SEC filings, Corporate Presentations, press release, news, and specification sheet of manufacturers, system integrators, brick and mortar - distributors and retailers, and third party online commerce players.
  • Scientific journals, and other technical magazines and whitepapers.

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Preliminary Data Mining

The raw data is obtained through the secondary findings, in house repositories, and trade surveys. It is then filtered to ensure that the relevant information including industry dynamics, trends, and outlook is retained for further research process.

Data Standardization:

Holistic approach is used to ensure that the granular and uncommon parameters are taken into consideration to ensure accurate results. The information from the paid databases are further combined to the raw data in order to standardize it.

Coherent Statistical model

We arrive at our final research findings through simulation models. Coherent Data Analytics Model is a statistical tool that helps company to forecast market estimates. Few of the parameters considered as a part of the statistical model include:

  • Micro-economic indicators
  • Macro-economic indicators
  • Environmental indicators
  • Socio-political indicators
  • Technology indicators

Data Processing

Once the findings are derived from the statistical model, large volume of data is process to confirm accurate research results. Data analytics and processing tools are adopted to process large chunk of collected informative data. In case, a client customizes the study during the process, the research finding till then are benchmarked, and the process for new research requirement is initiated again.

Data Validation

This is the most crucial stage of the research process. Primary Interviews are conducted to validate the data and analysis. This helps in achieving the following purposes:

  • It provides first-hand information on the market dynamics, outlook, and growth parameters.
  • Industry experts validates the estimates which helps the company to cement the on-going research study.
  • Primary research includes online surveys, face-to face interviews, and telephonic interviews.

The primary research is conducted with the ecosystem players including, but not limited to:

  • Raw Material Suppliers
  • Manufacturers
  • System Integrators
  • Distributors
  • End-users

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