Summary

U.S. Clinical Trials Management System Market Summary

The U.S. clinical trials management system market size was estimated at USD 831.22 million in 2024 and is expected to grow at a CAGR of 13.5% from 2025 to 2030. The rapid growth of healthcare IT, a preference for decentralized clinical trials, initiatives by key industry players, and a rising number of clinical studies are expected to fuel market growth. For instance, in November 2024, the FDA finalized its guidance on decentralized clinical trials (DCTs), emphasizing integrating remote elements like telehealth visits and digital health technologies to enhance trial accessibility and efficiency. This approach aims to broaden participation, especially among underrepresented populations, by reducing geographic and economic barriers to clinical trial involvement.

The current scenario for global research and development activities and the need for several new treatment options have also led to the adoption of fast-track clinical trials. Thus, the factors above are estimated to offer new avenues for the clinical trials market growth. Favorable government support and initiatives are another aspect boosting the market growth potential. For instance, the WHO launched Solidarity, an international clinical trial to determine effective treatment against COVID-19. It includes comparing four treatment options against the standard of care to evaluate their effectiveness against the coronavirus.

Government initiatives and investments by biotechnology and pharmaceutical firms are driving medical research activities. Combined with technological advancements, these factors are expected to propel market growth. For example, in October 2023, the Advanced Research Projects Agency for Health (ARPA-H), a U.S. Department of Health and Human Services (HHS) agency, announced plans to enhance the country's ability to conduct clinical trials rapidly, safely, and equitably. This initiative aims to promote technological advancements and insights to establish a robust national clinical trial infrastructure, thereby fostering the adoption of CTMS and strengthening the market growth.

Moreover, market players are introducing tailored solutions or optimizing existing ones to cater to the requirements of Decentralized Clinical Trials (DCTs). For instance, Cloudbyz offers a cloud-based CTM solution with features like ePRO, remote monitoring & SDV, eConsent, and eCRF, supporting virtual trials. Parexel International Corporation, a key player, has conducted over 250 fully virtual or hybrid DCTs and has experience with various remote patient engagement strategies incorporated into trials.

Increasing R&D investments by life science and medical device companies, coupled with the growing prevalence of acute & chronic disorders, are driving the surge in clinical trials. This trend is expected to boost the demand for solutions like CTMS, facilitating efficient management of diverse clinical trials and ultimately improving patient outcomes.

U.S. Clinical Trial Management System Market Report Segmentation

This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. clinical trial management systems market report based on solution type, component, delivery mode, and end use:
• Solution Type Outlook (Revenue, USD Million, 2018 - 2030)
• Enterprise
• Site
• Component Outlook (Revenue, USD Million, 2018 - 2030)
• Software
• Services
• Delivery Mode Outlook (Revenue, USD Million, 2018 - 2030)
• Web & Cloud Based
• On Premise
• End use Outlook (Revenue, USD Million, 2018 - 2030)
• Pharmaceutical and Biotechnology Firms
• Medical Device Firms
• CROs & Others

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Table of Contents

Table of Contents

Chapter 1. Methodology and Scope
1.1. Market Segmentation & Scope
1.2. Segment Definitions
1.2.1. Solution Type
1.2.2. Component
1.2.3. Delivery Mode
1.2.4. End use
1.3. Estimates and Forecast Timeline
1.4. Research Methodology
1.5. Information Procurement
1.5.1. Purchased Database
1.5.2. GVR’s Internal Database
1.5.3. Secondary Sources
1.5.4. Primary Research
1.6. Information Analysis
1.6.1. Data Analysis Models
1.7. Market Formulation & Data Visualization
1.8. Model Details
1.8.1. Commodity Flow Analysis
1.9. List of Secondary Sources
1.10. Objectives
Chapter 2. Executive Summary
2.1. Market Snapshot
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
Chapter 3. Market Variables, Trends, & Scope
3.1. Market Lineage Outlook
3.2. Market Dynamics
3.2.1. Market Driver Analysis
3.2.1.1. Shift Toward Decentralized and Hybrid Trials
3.2.1.2. Need for Operational Efficiency and Cost Reduction
3.2.1.3. Growing Focus on Patient-Centric Trials
3.2.2. Market Restraint Analysis
3.2.2.1. High Implementation and Maintenance Costs
3.2.2.2. Data privacy and Security Concerns
3.2.2.3. Complex regulatory environment
3.2.3. Market Opportunity Analysis
3.2.4. Market Threat Analysis
3.3. Business Environment Analysis
3.3.1. Porter’s Five Forces Analysis
3.3.1.1. Supplier power
3.3.1.2. Buyer power
3.3.1.3. Substitution threat
3.3.1.4. Threat of new entrant
3.3.1.5. Competitive rivalry
3.3.2. PESTLE Analysis
3.3.2.1. Political Analysis
3.3.2.2. Economic Analysis
3.3.2.3. Technological Analysis
3.3.2.4. Environmental Analysis
3.3.2.5. Social Analysis
3.3.3. Impact of COVID 19
Chapter 4. U.S. Clinical Trial Management System Market: Solution Type Estimates & Trend Analysis
4.1. Segment Dashboard
4.1.1. U.S. Clinical Trial Management System Market: Solution Type Movement Analysis, 2024& 2030 (USD Million)
4.2. Enterprise
4.2.1. Enterprise Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
4.3. Site
4.3.1. Site Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 5. U.S. Clinical Trial Management System Market: Component Estimates & Trend Analysis
5.1. Component Segment Dashboard
5.2. Component Market Share Movement Analysis, 2024 & 2030
5.3. Market Size & Forecasts and Trend Analysis, by Component, 2018 to 2030 (USD Million)
5.4. Software
5.4.1. Software market 2018 - 2030 (USD Million)
5.5. Services
5.5.1. Services market, 2018 - 2030 (USD Million)
Chapter 6. U.S. Clinical Trial Management System Market: Delivery Mode Estimates & Trend Analysis
6.1. Delivery Mode Segment Dashboard
6.2. Delivery Mode Market Share Movement Analysis, 2024 & 2030
6.3. Market Size & Forecasts and Trend Analysis, by Deliver Mode, 2018 to 2030 (USD Million)
6.4. Web & Cloud-Based Systems
6.4.1. Web & cloud-based Systems market, 2018 - 2030 (USD Million)
6.5. On premise systems
6.5.1. On premise systems market, 2018 - 2030 (USD Million)
Chapter 7. U.S. Clinical Trial Management System Market: End Use Estimates & Trend Analysis
7.1. End Use Segment Dashboard
7.2. End Use Market Share Movement Analysis, 2024 & 2030
7.3. Market Size & Forecasts and Trend Analysis, by End Use, 2018 to 2030 (USD Million)
7.4. Pharmaceutical and Biotechnology Firms
7.4.1. Pharmaceutical and Biotechnology Firms market, 2018 - 2030 (USD Million)
7.5. Medical Device Firms
7.5.1. Medical Device Firms market, 2018 - 2030 (USD Million)
7.6. CROs & Others
7.6.1. CROs & Others market, 2018 - 2030 (USD Million) 
Chapter 8. Competitive Landscape
8.1. Participant Overview
8.2. Company Market Position Analysis
8.3. Company Categorization
8.4. Company Profiles/Listing
8.4.1. IQVIA, Inc.
8.4.1.1. Overview
8.4.1.2. Financial performance
8.4.1.3. Product benchmarking
8.4.1.4. Strategic initiatives
8.4.2. Medidata (Dassault Systèmes)
8.4.2.1. Overview
8.4.2.2. Financial performance
8.4.2.3. Product benchmarking
8.4.2.4. Strategic initiatives
8.4.3. Oracle
8.4.3.1. Overview
8.4.3.2. Financial performance
8.4.3.3. Product benchmarking
8.4.3.4. Strategic initiatives
8.4.4. DATATRAK International, Inc.
8.4.4.1. Overview
8.4.4.2. Financial performance
8.4.4.3. Product benchmarking
8.4.4.4. Strategic initiatives
8.4.5. Clario
8.4.5.1. Overview
8.4.5.2. Financial performance
8.4.5.3. Product benchmarking
8.4.5.4. Strategic initiatives
8.4.6. SimpleTrials
8.4.6.1. Overview
8.4.6.2. Financial performance
8.4.6.3. Product benchmarking
8.4.6.4. Strategic initiatives
8.4.7. Calyx (formerly Parexel Informatics)
8.4.7.1. Overview
8.4.7.2. Financial performance
8.4.7.3. Product benchmarking
8.4.7.4. Strategic initiatives
8.4.8. RealTime Software Solutions, LLC
8.4.8.1. Overview
8.4.8.2. Financial performance
8.4.8.3. Product benchmarking
8.4.8.4. Strategic initiatives
8.4.9. Laboratory Corporation of America Holdings
8.4.9.1. Overview
8.4.9.2. Financial performance
8.4.9.3. Product benchmarking
8.4.9.4. Strategic initiatives
8.4.10. Veeva Systems
8.4.10.1. Overview
8.4.10.2. Financial performance
8.4.10.3. Product benchmarking
8.4.10.4. Strategic initiatives
8.4.11. Wipro Limited
8.4.11.1. Overview
8.4.11.2. Financial performance
8.4.11.3. Product benchmarking
8.4.11.4. Strategic initiatives
8.4.12. MedRhythms
8.4.12.1. Overview
8.4.12.2. Financial performance
8.4.12.3. Product benchmarking
8.4.12.4. Strategic initiatives