Abstract
Summary
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, Hospital, 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 key market players operating in the North America e-clinical solutions market are listed below:
• 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 Contents
1 INTRODUCTION 24
1.1 OBJECTIVES OF THE STUDY 24
1.2 MARKET DEFINITION 24
1.3 OVERVIEW 24
1.4 CURRENCY AND PRICING 26
1.5 LIMITATIONS 26
1.6 MARKETS COVERED 26
2 MARKET SEGMENTATION 29
2.1 MARKETS COVERED 29
2.2 GEOGRAPHICAL SCOPE 30
2.3 YEARS CONSIDERED FOR THE STUDY 31
2.4 DBMR TRIPOD DATA VALIDATION MODEL 32
2.5 PRIMARY INTERVIEWS WITH KEY OPINION LEADERS 35
2.6 MULTIVARIATE MODELLING 36
2.7 MARKET END USER COVERAGE GRID 37
2.8 PRODUCT LIFELINE CURVE 38
2.9 DBMR MARKET POSITION GRID 39
2.10 VENDOR SHARE ANALYSIS 40
2.11 SECONDARY SOURCES 41
2.12 ASSUMPTIONS 41
3 EXECUTIVE SUMMARY 42
4 PREMIUM INSIGHTS 45
4.1 PORTER'S FIVE FORCES MODEL 46
4.2 ECOSYSTEMS ANALYSIS OF E CLINICAL SOLUTIONS 47
4.3 USE CASES 49
5 VALUE CHAIN ANALYSIS 50
6 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET: REGULATIONS 51
7 MARKET OVERVIEW 57
7.1 DRIVERS 59
7.1.1 THE GROWING USAGE OF E-CLINICAL SOLUTIONS IN CLINICAL TRIALS 59
7.1.2 INCREASING R&D ACTIVITIES AND CORRESPONDING EXPENDITURE 59
7.1.3 STRATEGIC INITIATIVES TAKEN BY MAJOR BIOTECHNOLOGY AND PHARMACEUTICAL COMPANIES 60
7.1.4 IMPROVED HEALTHCARE INFRASTRUCTURE AND ESTABLISHMENT OF ADVANCED LABORATORIES 60
7.2 RESTRAINTS 61
7.2.1 DATA SAFETY AND PRIVACY ISSUES 61
7.2.2 LACK OF SKILLED PROFESSIONALS 61
7.2.3 LIMITED ADOPTION OF E-CLINICAL SOLUTIONS IN EMERGING COUNTRIES DUE TO BUDGETARY CONSTRAINTS AND POOR MANAGEMENT POLICIES 62
7.3 OPPORTUNITIES 62
7.3.1 RISING ADOPTION OF ELECTRONIC DATA CAPTURE (EDC) SYSTEMS AND CLOUD-BASED SOLUTIONS 62
7.3.2 INCREASING INVESTMENTS BY VARIOUS GOVERNMENTS IN CLINICAL TRIALS 63
7.3.3 GROWING FOCUS ON PATIENT-CENTRIC CLINICAL TRIALS 63
7.4 CHALLENGES 64
7.4.1 REGULATORY CHALLENGES ASSOCIATED WITH E-CLINICAL SOLUTIONS 64
7.4.2 HIGH IMPLEMENTATION COSTS 64
8 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY PRODUCT 66
8.1 OVERVIEW 67
8.2 ELECTRONIC DATA CAPTURE AND CLINICAL DATA MANAGEMENT SYSTEMS 70
8.3 RANDOMIZATION AND TRIAL SUPPLY MANAGEMENT 71
8.4 CLINICAL TRIAL MANAGEMENT SYSTEMS 72
8.5 ELECTRONIC TRIAL MASTER FILE SYSTEMS 73
8.6 ELECTRONIC CLINICAL OUTCOME ASSESSMENT SOLUTIONS 74
8.7 SAFETY SOLUTIONS 75
8.8 REGULATORY INFORMATION MANAGEMENT SOLUTIONS 76
8.9 CLINICAL DATA INTEGRATION PLATFORMS 77
8.10 CLINICAL ANALYTICS PLATFORMS 78
8.11 CARE COORDINATION MEDICAL RECORD (CCMR) 79
8.12 OTHERS 80
9 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY DELIVERY MODE 82
9.1 OVERVIEW 83
9.2 WEB-HOSTED (ON-DEMAND) SOLUTIONS 86
9.3 CLOUD-BASED (SAAS) SOLUTIONS 86
9.4 LICENSED ENTERPRISE (ON-PREMISES) SOLUTIONS 87
10 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY CLINICAL TRIAL PHASE 89
10.1 OVERVIEW 90
10.2 PHASE III 93
10.3 PHASE I 93
10.4 PHASE II 94
10.5 PHASE IV 95
11 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY ORGANIZATION SIZE 96
11.1 OVERVIEW 97
11.2 MEDIUM AND SMALL 100
11.3 LARGE 101
12 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY USER DEVICE 102
12.1 OVERVIEW 103
12.2 DESKTOP 106
12.3 TABLET 106
12.4 SMART PHONE 107
12.5 HANDHELD PDA DEVICE 108
12.6 OTHERS 108
13 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY END USER 110
13.1 OVERVIEW 111
13.2 CONTRACT RESEARCH ORGANIZATIONS 114
13.3 PHARMACEUTICAL AND BIOPHARMACEUTICAL COMPANIES 114
13.4 MEDICAL DEVICE MANUFACTURERS 115
13.5 HOSPITAL 116
13.6 CONSULTING SERVICE COMPANIES 116
13.7 ACADEMIC RESEARCH INSTITUTES 117
14 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, BY REGION 118
14.1 NORTH AMERICA 119
14.1.1 U.S 126
14.1.2 CANADA 129
14.1.3 MEXICO 132
15 NORTH AMERICA E-CLINICAL SOLUTIONS MARKET, COMPANY LANDSCAPE 135
15.1 COMPANY SHARE ANALYSIS: NORTH AMERICA 135
16 SWOT ANALYSIS 136
17 COMPANY PROFILE 137
17.1 ORACLE 137
17.1.1 COMPANY SNAPSHOT 137
17.1.2 REVENUE ANALYSIS 137
17.1.3 COMPANY SHARE ANALYSIS 138
17.1.4 PRODUCT PORTFOLIO 138
17.1.5 RECENT DEVELOPMENT 138
17.2 DASSAULT SYSTEMES 139
17.2.1 COMPANY SNAPSHOT 139
17.2.2 REVENUE ANALYSIS 139
17.2.3 COMPANY SHARE ANALYSIS 140
17.2.4 PRODUCT PORTFOLIO 140
17.2.5 RECENT DEVELOPMENTS 141
17.3 CLARIO 142
17.3.1 COMPANY SNAPSHOT 142
17.3.2 COMPANY SHARE ANALYSIS 142
17.3.3 PRODUCT PORTFOLIO 143
17.3.4 RECENT DEVELOPMENT 143
17.4 VEEVA SYSTEMS 144
17.4.1 COMPANY SNAPSHOT 144
17.4.2 REVENUE ANALYSIS 144
17.4.3 COMPANY SHARE ANALYSIS 145
17.4.4 PRODUCT PORTFOLIO 145
17.4.5 RECENT DEVELOPMENTS 146
17.5 ARISNORTH AMERICA 147
17.5.1 COMPANY SNAPSHOT 147
17.5.2 COMPANY SHARE ANALYSIS 147
17.5.3 PRODUCT PORTFOLIO 148
17.5.4 RECENT DEVELOPMENTS 148
17.6 4G CLINICAL 149
17.6.1 COMPANY SNAPSHOT 149
17.6.2 PRODUCT PORTFOLIO 149
17.6.3 RECENT DEVELOPMENT 149
17.7 ADVARRA 150
17.7.1 COMPANY SNAPSHOT 150
17.7.2 PRODUCT PORTFOLIO 150
17.7.3 RECENT DEVELOPMENT 150
17.8 ANJU 151
17.8.1 COMPANY SNAPSHOT 151
17.8.2 PRODUCT PORTFOLIO 151
17.8.3 RECENT DEVELOPMENTS 152
17.9 CASTOR 153
17.9.1 COMPANY SNAPSHOT 153
17.9.2 PRODUCT PORTFOLIO 153
17.9.3 RECENT DEVELOPMENTS 153
17.10 DATATRAK INT 154
17.10.1 COMPANY SNAPSHOT 154
17.10.2 PRODUCT PORTFOLIO 154
17.10.3 RECENT DEVELOPMENT 154
17.11 ECLINICAL SOLUTIONS LLC 155
17.11.1 COMPANY SNAPSHOT 155
17.11.2 PRODUCT PORTFOLIO 155
17.11.3 RECENT DEVELOPMENT 155
17.12 IQVIA INC 156
17.12.1 COMPANY SNAPSHOT 156
17.12.2 REVENUE ANALYSIS 156
17.12.3 PRODUCT PORTFOLIO 157
17.12.4 RECENT DEVELOPMENTS 157
17.13 MAXISIT 158
17.13.1 COMPANY SNAPSHOT 158
17.13.2 PRODUCT PORTFOLIO 158
17.13.3 RECENT DEVELOPMENT 159
17.14 MEDNET 160
17.14.1 COMPANY SNAPSHOT 160
17.14.2 PRODUCT PORTFOLIO 160
17.14.3 RECENT DEVELOPMENT 161
17.15 MEDRIO, INC 162
17.15.1 COMPANY SNAPSHOT 162
17.15.2 PRODUCT PORTFOLIO 162
17.15.3 RECENT DEVELOPMENTS 163
17.16 MERATIVE 164
17.16.1 COMPANY SNAPSHOT 164
17.16.2 PRODUCT PORTFOLIO 164
17.16.3 RECENT DEVELOPMENT 164
17.17 OPENCLINICA, LLC 165
17.17.1 COMPANY SNAPSHOT 165
17.17.2 PRODUCT PORTFOLIO 165
17.17.3 RECENT DEVELOPMENT 165
17.18 PAREXEL INTERNATIONAL CORPORATION 166
17.18.1 COMPANY SNAPSHOT 166
17.18.2 PRODUCT PORTFOLIO 166
17.18.3 RECENT DEVELOPMENT 166
17.19 QURETEC 167
17.19.1 COMPANY SNAPSHOT 167
17.19.2 PRODUCT PORTFOLIO 167
17.19.3 RECENT DEVELOPMENT 167
17.20 REALTIME SOFTWARE SOLUTIONS, LLC 168
17.20.1 COMPANY SNAPSHOT 168
17.20.2 PRODUCT PORTFOLIO 168
17.20.3 RECENT DEVELOPMENT 168
17.21 RESEARCH MANAGER 169
17.21.1 COMPANY SNAPSHOT 169
17.21.2 PRODUCT PORTFOLIO 169
17.21.3 RECENT DEVELOPMENT 169
17.22 SAAMA TECHNOLOGIES, LLC 170
17.22.1 COMPANY SNAPSHOT 170
17.22.2 PRODUCT PORTFOLIO 170
17.22.3 RECENT DEVELOPMENT 170
17.23 SIGNANT HEALTH 171
17.23.1 COMPANY SNAPSHOT 171
17.23.2 PRODUCT PORTFOLIO 171
17.23.3 RECENT DEVELOPMENT 171
17.24 Y-PRIME, LLC 172
17.24.1 COMPANY SNAPSHOT 172
17.24.2 PRODUCT PORTFOLIO 172
17.24.3 RECENT DEVELOPMENT 172
18 QUESTIONNAIRE 173
19 RELATED REPORTS 176