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North America e-Clinical Solutions Market - Industry Trends and Forecast to 2030
- Published Date: August, 2023 | Report ID: CLS-1991 | No of pages: 143 | Format:
The North America e-clinical solutions market is expected to reach USD 8,167.32 million by 2030 from USD 2,769.17 million in 2022, growing with a CAGR of 14.5% during the forecast period from 2023 to 2030.
Market Segmentation
North America E-clinical Solutions Market, By Product (Electronic Data Capture and Clinical Data Management Systems, Randomization and Trial Supply Management, Clinical Trial Management Systems, Electronic Trial Master File Systems, Electronic Clinical Outcome Assessment Solutions, Safety Solutions, Regulatory Information Management Solutions, Clinical Data Integration Platforms, Clinical Analytics Platforms, Care Coordination Medical Record (CCMR), and Others), Delivery Mode (Web-Hosted (On-Demand) Solutions, Cloud-Based (SaaS) Solutions, and Licensed Enterprise (On-Premises) Solutions), Clinical Trial Phase (Phase I, Phase II, Phase III, and Phase IV), Organization Size (Medium and small, and Large), User Device (Desktop, Tablet, Smart Phone, Handheld PDA Device, and Others), End User (Contract Research Organizations, Pharmaceutical and Biopharmaceutical Companies, Medical Device Manufacturers, Hospitals, Consulting Service Companies, and Academic Research Institutes) - Industry Trends and Forecast to 2030
Overview of North America E-clinical Solutions Market Dynamics
Driver
• The growing usage of e-clinical solutions in clinical trials
Restraint
• Data safety and privacy issues
Opportunity
• Rising adoption of electronic data capture (EDC) systems and cloud-based solutions
Market Players
Some of the major market players operating in the North America e-clinical solutions market are:
• Clario
• Oracle
• OpenClinica, LLC
• Dassault Systèmes
• Signant Health
• MaxisIT
• PAREXEL INTERNATIONAL CORPORATION
• Mednet
• 4G Clinical
• Saama Technologies, LLC.
• ANJU SOFTWARE (PORTFOLIO COMPANY OF ABRY PARTNERS)
• Veeva Systems
• Medrio, Inc.
• Castor
• ArisGlobal
• Merative
• Advarra
• RealTime Software Solutions, LLC
• Y-Prime, LLC.
• eClinical Solutions LLC.
• Datatrak Int.
• IQVIA Inc
TABLE OF CONTENT
1 INTRODUCTION 13
1.1 OBJECTIVES OF THE STUDY 13
1.2 MARKET DEFINITION 13
1.3 OVERVIEW 13
1.4 CURRENCY AND PRICING 15
1.5 LIMITATIONS 15
1.6 MARKETS COVERED 15
2 MARKET SEGMENTATION 17
2.1 MARKETS COVERED 17
2.2 GEOGRAPHICAL SCOPE 18
2.3 YEARS CONSIDERED FOR THE STUDY 18
2.4 Cognate Lifesciences TRIPOD DATA VALIDATION MODEL 19
2.5 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 22
2.6 MULTIVARIATE MODELLING 23
2.7 MARKET END USER COVERAGE GRID 24
2.8 PRODUCT LIFELINE CURVE 25
2.9 Cognate Lifesciences MARKET POSITION GRID 26
2.10 VENDOR SHARE ANALYSIS 27
2.11 SECONDARY SOURCES 28
2.12 ASSUMPTIONS 28
3 EXECUTIVE SUMMARY 29
4 PREMIUM INSIGHTS 32
4.1 PORTER'S FIVE FORCES MODEL 33
4.2 ECOSYSTEMS ANALYSIS OF E-CLINICAL SOLUTIONS 34
4.3 USE CASES 36
5 VALUE CHAIN ANALYSIS 37
6 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET: REGULATIONS 38
7 MARKET OVERVIEW 39
7.1 DRIVERS 41
7.1.1 THE GROWING USAGE OF E-CLINICAL SOLUTIONS IN CLINICAL TRIALS 41
7.1.2 INCREASING R&D ACTIVITIES AND CORRESPONDING EXPENDITURE 41
7.1.3 STRATEGIC INITIATIVES TAKEN BY MAJOR BIOTECHNOLOGY AND PHARMACEUTICAL COMPANIES 42
7.1.4 IMPROVED HEALTHCARE INFRASTRUCTURE AND ESTABLISHMENT OF ADVANCED LABORATORIES 42
7.2 RESTRAINTS 43
7.2.1 DATA SAFETY AND PRIVACY ISSUES 43
7.2.2 LACK OF SKILLED PROFESSIONALS 43
7.2.3 LIMITED ADOPTION OF E-CLINICAL SOLUTIONS IN EMERGING COUNTRIES DUE TO BUDGETARY CONSTRAINTS AND POOR MANAGEMENT POLICIES 44
7.3 OPPORTUNITIES 44
7.3.1 RISING ADOPTION OF ELECTRONIC DATA CAPTURE (EDC) SYSTEMS AND CLOUD-BASED SOLUTIONS 44
7.3.2 INCREASING INVESTMENTS BY VARIOUS GOVERNMENTS IN CLINICAL TRIALS 45
7.3.3 GROWING FOCUS ON PATIENT-CENTRIC CLINICAL TRIALS 45
7.4 CHALLENGES 46
7.4.1 REGULATORY CHALLENGES ASSOCIATED WITH E-CLINICAL SOLUTIONS 46
7.4.2 HIGH IMPLEMENTATION COSTS 46
8 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY PRODUCT 48
8.1 OVERVIEW 49
8.2 ELECTRONIC DATA CAPTURE AND CLINICAL DATA MANAGEMENT SYSTEMS 52
8.3 RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT 52
8.4 CLINICAL TRIAL MANAGEMENT SYSTEMS 53
8.5 ELECTRONIC TRIAL MASTER FILE SYSTEMS 53
8.6 ELECTRONIC CLINICAL OUTCOME ASSESSMENT SOLUTIONS 54
8.7 SAFETY SOLUTIONS 54
8.8 REGULATORY INFORMATION MANAGEMENT SOLUTIONS 55
8.9 CLINICAL DATA INTEGRATION PLATFORMS 55
8.10 CLINICAL ANALYTICS PLATFORMS 56
8.11 CARE COORDINATION MEDICAL RECORD (CCMR) 57
8.12 OTHERS 57
9 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY DELIVERY MODE 58
9.1 OVERVIEW 59
9.2 WEB-HOSTED (ON-DEMAND) SOLUTIONS 62
9.3 CLOUD-BASED (SAAS) SOLUTIONS 62
9.4 LICENSED ENTERPRISE (ON-PREMISES) SOLUTIONS 62
10 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY CLINICAL TRIAL PHASE 64
10.1 OVERVIEW 65
10.2 PHASE III 68
10.3 PHASE I 68
10.4 PHASE II 69
10.5 PHASE IV 70
11 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY ORGANIZATION SIZE 71
11.1 OVERVIEW 72
11.2 MEDIUM AND SMALL 75
11.3 LARGE 75
12 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY USER DEVICE 76
12.1 OVERVIEW 77
12.2 DESKTOP 80
12.3 TABLET 80
12.4 SMART PHONE 80
12.5 HANDHELD PDA DEVICE 81
12.6 OTHERS 81
13 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY END USER 82
13.1 OVERVIEW 83
13.2 CONTRACT RESEARCH ORGANIZATIONS 86
13.3 PHARMACEUTICAL AND BIOPHARMACEUTICAL COMPANIES 86
13.4 MEDICAL DEVICE MANUFACTURERS 86
13.5 HOSPITAL 87
13.6 CONSULTING SERVICE COMPANIES 87
13.7 ACADEMIC RESEARCH INSTITUTES 87
14 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY COUNTRY 88
14.1 NORTH AMERICA 89
14.1.1 U.S. 94
14.1.2 CANADA 97
14.1.3 MEXICO 100
15 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, COMPANY LANDSCAPE 103
15.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 103
16 SWOT ANALYSIS 104
17 COMPANY PROFILE 105
17.1 ORACLE 105
17.1.1 COMPANY SNAPSHOT 105
17.1.2 REVENUE ANALYSIS 105
17.1.3 PRODUCT PORTFOLIO 106
17.1.4 RECENT DEVELOPMENT 106
17.2 DASSAULT SYSTEMES 107
17.2.1 COMPANY SNAPSHOT 107
17.2.2 REVENUE ANALYSIS 107
17.2.3 PRODUCT PORTFOLIO 108
17.2.4 RECENT DEVELOPMENTS 109
17.3 CLARIO 110
17.3.1 COMPANY SNAPSHOT 110
17.3.2 PRODUCT PORTFOLIO 110
17.3.3 RECENT DEVELOPMENT 110
17.4 VEEVA SYSTEMS 111
17.4.1 COMPANY SNAPSHOT 111
17.4.2 REVENUE ANALYSIS 111
17.4.3 PRODUCT PORTFOLIO 112
17.4.4 RECENT DEVELOPMENTS 113
17.5 ARISNORTH AMERICA 114
17.5.1 COMPANY SNAPSHOT 114
17.5.2 PRODUCT PORTFOLIO 114
17.5.3 RECENT DEVELOPMENTS 114
17.6 4G CLINICAL 116
17.6.1 COMPANY SNAPSHOT 116
17.6.2 PRODUCT PORTFOLIO 116
17.6.3 RECENT DEVELOPMENT 116
17.7 ADVARRA. 117
17.7.1 COMPANY SNAPSHOT 117
17.7.2 PRODUCT PORTFOLIO 117
17.7.3 RECENT DEVELOPMENT 117
17.8 ANJU 118
17.8.1 COMPANY SNAPSHOT 118
17.8.2 PRODUCT PORTFOLIO 118
17.8.3 RECENT DEVELOPMENTS 119
17.9 CASTOR. 120
17.9.1 COMPANY SNAPSHOT 120
17.9.2 PRODUCT PORTFOLIO 120
17.9.3 RECENT DEVELOPMENTS 120
17.10 DATATRAK INT. 121
17.10.1 COMPANY SNAPSHOT 121
17.10.2 PRODUCT PORTFOLIO 121
17.10.3 RECENT DEVELOPMENT 121
17.11 ECLINICAL SOLUTIONS LLC. 122
17.11.1 COMPANY SNAPSHOT 122
17.11.2 PRODUCT PORTFOLIO 122
17.11.3 RECENT DEVELOPMENT 122
17.12 IQVIA INC 123
17.12.1 COMPANY SNAPSHOT 123
17.12.2 REVENUE ANALYSIS 123
17.12.3 PRODUCT PORTFOLIO 124
17.12.4 RECENT DEVELOPMENTS 124
17.13 MAXISIT 125
17.13.1 COMPANY SNAPSHOT 125
17.13.2 PRODUCT PORTFOLIO 125
17.13.3 RECENT DEVELOPMENT 126
17.14 MEDNET 127
17.14.1 COMPANY SNAPSHOT 127
17.14.2 PRODUCT PORTFOLIO 127
17.14.3 RECENT DEVELOPMENT 128
17.15 MEDRIO, INC. 129
17.15.1 COMPANY SNAPSHOT 129
17.15.2 PRODUCT PORTFOLIO 129
17.15.3 RECENT DEVELOPMENTS 130
17.16 MERATIVE 131
17.16.1 COMPANY SNAPSHOT 131
17.16.2 PRODUCT PORTFOLIO 131
17.16.3 RECENT DEVELOPMENT 131
17.17 OPENCLINICA, LLC 132
17.17.1 COMPANY SNAPSHOT 132
17.17.2 PRODUCT PORTFOLIO 132
17.17.3 RECENT DEVELOPMENT 132
17.18 PAREXEL INTERNATIONAL CORPORATION 133
17.18.1 COMPANY SNAPSHOT 133
17.18.2 PRODUCT PORTFOLIO 133
17.18.3 RECENT DEVELOPMENT 133
17.19 REALTIME SOFTWARE SOLUTIONS, LLC 135
17.19.1 COMPANY SNAPSHOT 135
17.19.2 PRODUCT PORTFOLIO 135
17.19.3 RECENT DEVELOPMENT 135
17.20 SAAMA TECHNOLOGIES, LLC 136
17.20.1 COMPANY SNAPSHOT 136
17.20.2 PRODUCT PORTFOLIO 136
17.20.3 RECENT DEVELOPMENT 136
17.21 SIGNANT HEALTH 137
17.21.1 COMPANY SNAPSHOT 137
17.21.2 PRODUCT PORTFOLIO 137
17.21.3 RECENT DEVELOPMENT 137
17.22 Y-PRIME, LLC. 138
17.22.1 COMPANY SNAPSHOT 138
17.22.2 PRODUCT PORTFOLIO 138
17.22.3 RECENT DEVELOPMENT 138
18 QUESTIONNAIRE 139
19 RELATED REPORTS 143
Segmentation
Short Description
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), Country (U.S., Canada, and Mexico) – Industry Trends and Forecast To 2030
Market Definition
The goal of eClinical 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 and facilitate the standardization, reporting, and operation of the clinical research domain. The rising adoption and growing focus towards the e clinical solutions and software is expected to drive market growth.
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.
Market Segmentation
The 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.
• On the basis of product, the market is segmented into 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
• 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
• On the basis of clinical trial phase, the market is segmented into phase I, phase II, phase III, and phase IV
• On the basis of organization size, the market is segmented into small & medium, and large
• On the basis of user device, the market is segmented into desktop, tablet, handheld PDA device, smart phone, and others
• 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
Market Players
Some of the major market players operating in the North America e-clinical solutions market are:
• Oracle
• Signant Health
• MaxisIT
• Paraxel International Corporation
• Dassault Systemes
• Clario
• Mednet
• OpenClinica, LLC
• 4G Clinical
• Veeva Systems
• Saama Technologies, LLC
Methodology
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