North America E-Clinical Solutions Market – Industry Trends and Forecast to 2030

North America E-Clinical Solutions Market, By Product (Electronic Data Capture and Clinical Trial Data Management Systems, Clinical Trial Management Systems, Clinical Analytics Platforms, Care Coordination Medical Records (CCMR), Randomization and Trial Supply Management, Clinical Data Integration Platforms, Electronic Clinical Outcome Assessment Solutions, Safety Solutions, Electronic Trial Master File Systems, Regulatory Information Management Solutions, and Others), Delivery Mode (Web-Hosted (On-Demand) Solutions, Licensed Enterprise (On-Premises) Solutions, and Cloud-Based (SAAS) Solutions), Clinical Trial Phase (Phase I, Phase II, Phase III, and Phase IV),  Organization Size (Small & Medium and Large), User Device (Desktop, Tablet, Handheld PDA Device, Smart Phone, and Others), End User (Pharmaceutical and Biopharmaceutical Companies, Contract Research Organizations, Consulting Service Companies, Medical Device Manufacturers, Hospitals, and Academic Research Institutes) - Industry Trends and Forecast to 2030.

North America E-Clinical Solutions Market Analysis and Size

The North America e-clinical solutions market is fragmented in nature, as it consists of many global players such as Oracle, IQVIA Inc., Dassault Systemes, and Clario among others. The presence of these companies produces competitive prices for systems services and software across the region. Due to the presence of these players at regional and international levels, suppliers and manufacturers offer products with different specifications and characteristics in all budgets. The growing adoption of electronic data capture (EDC) systems and cloud-based is driving the market growth. In addition, the growing focus on patient-centric clinical trials is expected to drive the market growth.

Data Bridge Market Research analyzes that the North America e-clinical solutions market is expected to reach the value of USD 8,167.32 million by 2030, at a CAGR of 14.5% during the forecast period. This market report also covers pricing analysis and technological advancements in depth.

Market Definition

The goal of e-clinical solutions is to revolutionize the field of clinical research. The clinical management organization is trying to improve the effectiveness, efficiency, and accessibility of clinical research data to treat patients more quickly. The idea behind the creation of eClinical Solutions was to pinpoint the problems with clinical research data, fix them, and offer creative solutions to make clinical trial data useful and simple to obtain, as well as to facilitate the standardization, reporting, and operation of the clinical research domain. The rising adoption and growing focus towards the e clinical solutions and software are expected to drive market growth.

 The e-clinical solutions, such as electronic data capture (EDC), electronic patient-reported outcomes (ePRO), clinical trial management systems (CTMS), and electronic trial master file (eTMF) systems, are software programs used in clinical research to manage clinical data. However, strict regulations and standards for the approval of clinical trial studies and product approvals are expected to restrain the market growth.

North America E-Clinical Solutions Market Dynamics

This section deals with understanding the market drivers, opportunities, restraints, and challenges. All of this is discussed in detail below:

Drivers

Increasing R&D Activities and Corresponding Expenditure

R&D is crucial in all industries, including life science and healthcare. The life science industry carries out extensive research and development to generate revenue and often brings results that embrace saving or enhancing a patient's life. Drug development requires going through clinical trials to check clinical data analysis and review its study and new data insights.

The e-clinical solutions are used for comprehensive data review, automating the data transformation process, and analytics to accelerate timelines. Pharmaceutical and biopharmaceutical companies conduct many clinical trials to complete successful drug or biologic development. Pharmaceutical and biopharmaceutical companies have increased their focus on research and development, raising the demand for e-clinical solutions.

Improved Healthcare Infrastructure and Establishment of Advanced Laboratories

Infrastructure is a key pillar supporting the fundamental aim of promoting improved standards of care and well-being for all patients, together with a good healthcare system experience. In parallel, the healthcare system and staff must support effective health promotion, prevention, and self-care of the whole population.

Infrastructure must integrate the hospital, as the acute and in-patient care center, into the broader healthcare system. It should facilitate the seven domains of quality patient experience, effectiveness, efficiency, timeliness, safety, equity, and sustainability. Infrastructure includes the built environment and supporting elements such as equipment, access, information technology (IT), systems and processes, sustainability initiatives, and staff. This improved healthcare infrastructure and staff more opportunities for e-clinical solutions to grow and give better results.

Opportunity

• Increasing Investments By Various Governments In Clinical Trials 

Clinical trial funding comes from various sources, including the government, commercial investors, nonprofit organizations, academic institutions, and other research organizations. Historically, the National Institutes of Health (NIH) has made the biggest government investments in fundamental drug development research. The Defense Advanced Research Agency (DARPA) has also contributed to the discovery stage by accepting a few relatively high-risk biological initiatives. State governments are also increasingly taking the lead in this area, partly due to the public's frustration with the lengthy discovery process. Thus, government initiatives and investments toward discovering new drugs with trial studies are expected to act as market growth opportunities.

Restraint / Challenge

Data Safety and Privacy issues

Information systems are heavily concerned with privacy and security. Access to individual health information is made possible by digitalizing healthcare services from any electronic device with an internet connection anywhere globally. Users typically are unaware of how their data is handled. Healthcare data on the cloud has caught the attention of hackers, who target systems to launch attacks and steal sensitive data in exchange for financial benefit.

Data breaches have been common since 2019, over 50 million electronic medical records have been hacked, and in 2021, the number of security breaches is predicted to increase from the previous year. The creation of inter-jurisdictional data-sharing agreements and the storage and manipulation of data holdings are significantly hampered by concerns about personal privacy and information confidentiality and the recent enactment of privacy and confidentiality legislation across the provinces and territories (exceptionally patient records). Thus, it is expected to restrain market growth.

Recent Developments

• In April 2023, the Medidata subsidiary of Dassault Systèmes announced Lambda Therapeutics is deploying Medidata's cloud-based clinical products, Rave EDC, Rave RTSM, and Rave Imaging, according to a statement from Dassault Systèmes subsidiary Medidata. Automating and optimizing data management operations and securely delivering higher-quality data for quicker insights will further improve clinical trial productivity. This has aided the business in promoting its offerings across the globe.
• In March 2023, Clarion launched a cloud-based Image Viewer to help the Sponsors and CR to see the images of their clinical trials. Previously, several nations had to participate in the image transfer procedure to see photos for a clinical trial. This complicated the already risky process and increased the possibility of delays and mistakes. This has aided the business in growing its service offering.

North America E-Clinical Solutions Market Scope  

North America e-clinical solutions market is segmented into six notable segments on the basis of product, delivery mode, clinical trial phase, organization size, user device, and end user.

The growth amongst these segments will help you analyze meager growth segments in the industries and provide the users with a valuable market overview and insights to help them make strategic decisions for identifying core market applications.

Product

• Electronic Data Capture and Clinical Data Management Systems
• Clinical Trial Management Systems
• Clinical Analytics Platforms
• Care Coordination Medical Record (CCMR)
• Randomization and Trial Supply Management
• Clinical Data Integration Platforms
• Electronic Clinical Outcome Assessment Solutions
• Safety Solutions
• Electronic Trial Master File  Systems
• Regulatory Information Management Solutions
• Others

On the basis of product, the market is segmented into electronic data capture and clinical data management, clinical trial management systems,  clinical analytics platforms, care coordination medical record (CCMR), randomization and trial supply management, clinical data integration platforms, electronic clinical outcome assessment solutions, safety solutions, electronic trial master file systems, regulatory information management solutions, and others.

Delivery Mode

• Web-Hosted (On-Demand) Solutions
• Licensed Enterprise (On-Premises) Solutions
• Cloud-based (SAAS) Solutions

On the basis of delivery mode, the market is segmented into web-hosted ( on-demand) solutions, licensed enterprise (on-premises) solutions, and cloud-based (SAAS) solutions.

Clinical Trial Phase

• Phase I
• Phase II
• Phase III
• Phase IV

On the basis of clinical trial phase, the market is segmented into phase I, phase II, phase III, and phase IV.

Organization Size

• Small & Medium
• Large

On the basis of organization size, the market is segmented into small & medium and large.

User Device

• Desktop
• Tablet
• Handheld PDA Device
• Smart Phone
• Others

On the basis of user device, the market is segmented into desktop, tablet, handheld PDA device, smart phone, and others.

End User

• Pharmaceutical and Biopharmaceutical companies
• Contract Research Organizations
• Consulting Service Companies
• Medical Device Manufacturers
• Hospitals
• Academic Research Institutes

On the basis of end user, the market is segmented into pharmaceutical and biopharmaceutical companies, contract research organizations, consulting service companies, medical device manufacturers, hospitals, and academic research institutes.

North America E-Clinical Solutions Market Regional Analysis/Insights

The North America E-Clinical Solutions Market is analyzed, and market size information is based on product, delivery mode, clinical trial phase, organization size, user device, and end user.

The countries covered in this market report are U.S., Canada, and Mexico.

The U.S. is expected to dominate the North America region due to increasing investment in R&D for drug discovery and delivery and the presence of strong key players in the country.

The country section of the report also provides individual market-impacting factors and changes in regulation in the market domestically that impact the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts, and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, the presence and availability of Asia-Pacific brands and their challenges faced due to large or scarce competition from local and domestic brands and the impact of sales channels are considered while providing forecast analysis of the country data.

Competitive Landscape and Market Share Analysis

North America e-clinical solutions market competitive landscape provides details of the competitor. Details included are company overview, company financials, revenue generated, market potential, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, and application dominance. The above data points provided are only related to the companies' focus related to the market.

Some of the major market players operating in North America e- clinical solutions market are Oracle, Signant Health, MaxisIT, Paraxel International Corporation, Dassault Systèmes, Clario, Mednet, OpenClinica, LLC, 4G Clinical, Veeva Systems, Saama Technologies, LLC., Anju, Castor., Medrio, Inc., ArisGlobal, Merative, Advarra, eClinical Solutions, LLC., Y-Prime LLC, RealTime Software Solutions LLC, Quretec, Research Manager, Datatrack Int., and IQVIA Inc.,  among others.