According to Nova One Advisor, the global clinical trials support software solutions market size is calculated at USD 12.94 billion in 2025 and is expected to be hit around USD 30.78 billion by 2034, growing at a compound annual growth rate (CAGR) of 10.11% over the forecast period 2025 to 2034. A study published by Nova One Advisor a sister firm of Precedence Research.
Ottawa, Nov. 20, 2025 (GLOBE NEWSWIRE) — The global clinical trials support software solutions market size is calculated at USD 11.75 billion in 2024, grew to USD 12.94 billion in 2025, and is projected to reach around USD 30.78 billion by 2034. The market is projected to expand at a CAGR of 10.11% between 2025 and 2034.
Key Takeaways
- By region, North America held the largest share of the clinical trials support software solutions market in 2024.
- By region, Asia Pacific is expected to experience the fastest growth between 2025 and 2034.
- By product, the clinical trial management system (CTMS) segment led the market in 2024.
- By product, the payments/investigator payments solutions segment is expected to expand at the fastest CAGR during the forecast period.
- By delivery mode, the cloud and web-based segment led the market in 2024.
- By delivery mode, the on-premises segment is likely to grow at the fastest rate in the coming years.
- By phase, the phase III segment dominated the market in 2024.
- By phase, the phase I segment is expected to expand at the highest CAGR over the projection period.
- By end use, the contract research organizations (CROs) segment contributed the largest market share in 2024.
- By end use, the biopharmaceutical companies’ segment is expected to grow at a significant rate in the upcoming period.
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What is clinical trials support software?
Clinical trials support software offers visibility of various characteristics of the research on the website, enabling consumers to simply monitor the processes of research process. This type of software support improves the quality of clinical products, lowers the time it takes to get a product to market, and ensures compliance with manufacturing standards and guidelines. Clinical trial enrollment could predominantly improve because of AI’s integration in the electronic health records (EHRs). This type of communication highlights how AI enhances the recruitment process related to speed, precision, and overall efficiency of clinical trials. AI-driven technology automates these processes by using machine learning algorithms, detecting potential trial participants rapidly and precisely.
Integration of AI-driven technology in clinical trial software allows personalized treatment by detecting patient groups that respond to drugs. The increasing importance of each patient changes how well experimental healthcare works. AI-driven technology makes this simple by finding out patient populations that are a good fit based on lifestyle and genetic arrangement. Targeted medicine is made possible by the integration of AI technology. By enhancing dosing and identifying the standard dosage quantities and frequencies based on unique patient structures and healthcare history, AI-driven technology further modifies treatment.
- For Instance, In March 2025, Komodo Health announced an agreement with Janssen Research & Development, LLC (Janssen) to accelerate clinical development using real-world data and AI software. The collaboration aims to optimize feasibility, site selection, and patient recruitment for clinical trials, ultimately driving higher throughput for trials and speeding life-saving therapies to patients.
What are the Key Drivers in the Clinical Trials Support Software Solutions Market?
Clinical trial software plays a significant role in optimizing trial processes, thus leading to improved trial performance. It modernizes a multitude of responsibilities like patient recruitment, trial planning, analysis, and data collection. These apparatuses automate repetitive tasks, which are generally time-consuming, and enable researchers to focus more on the substantive aspects of the clinical trials. It drives a seamless workflow, providing rapid access to clinical research data and quickening the decision-making procedure. Clinical trial software drives seamless partnerships among the different stakeholders involved in a clinical trial, including clinicians, researchers, sponsors, and patients, which drives the growth of the market.
- For Instance, In October 2025, Suvoda, a global clinical trial technology company specializing in software solutions to address trial complexity in the mission-critical, time-sensitive moments, today announced a partnership with Bolt Business, a European mobility company, to expand affordable and accessible transportation options for clinical trial participants across the EU.
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Clinical Trials Support Software Solutions Market Report Scope
| Report Attribute | Details |
| Market size value in 2025 | USD 12.94 billion |
| Revenue forecast in 2034 | USD 30.78 billion |
| Growth rate | CAGR of 10.11% from 2025 to 2034 |
| Actual data | 2021 – 2024 |
| Forecast period | 2025 – 2034 |
| Quantitative units | Revenue in USD million/billion and CAGR from 2025 to 2034 |
| Report coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Segments covered | Product, Delivery Mode, Phase, End use, and Region |
| Regional scope | North America; Europe; Asia Pacific; Latin America; MEA |
| Country scope | U.S.; Canada; Mexico; Germany; UK; France; Italy; Spain; Norway; Denmark; Sweden; China; Japan; India; South Korea; Australia; Thailand; Brazil; Argentina; Saudi Arabia; South Africa; UAE; Kuwait |
| Customization scope | Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope. |
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What are the Ongoing Trends in the Clinical Trials Support Software Solutions Market?
- In November 2025, SAS, a worldwide leader in clinical research analytics, announced the general availability of SAS Clinical Acceleration. The cornerstone solution built on the SAS Viya platform modernizes and streamlines clinical trial data management, analysis, and regulatory submission for life sciences organizations.
- In September 2025, Roche Pharma inked a deal with ten government hospitals to scale up the clinical trial Network in India. The initiative, implemented in the US, the UK, Canada, and Africa, aligns with CDSCO and PRIP. Nearly 400 professionals, including investigators, ethics committee members, and support staff, have been trained according to global Good Clinical Practice (GCP) standards.
What is the Emerging Challenge in the Clinical Trials Support Software Solutions Market?
Clinical trial software often requires interaction with a diversity of other systems, like electronic health records (EHRs), laboratory information management systems (LIMS), and government submission platforms. Confirming data interoperability between these systems is an important and complex process. Differences in data formats, standards, and terminologies lead to discrepancies and data integrity challenges, making it problematic to consolidate and analyze data professionally.
By Regional Analysis
Why did North America Dominate the Market in 2024?
North America dominates the clinical trials support software solutions market due to strong existing medical care and pharmaceutical infrastructure, a helpful government environment, early acceptance of digital and AI-based technologies, and an increasing volume of healthcare research. Important R&D spending by pharmaceutical companies, along with regulatory funding, confirms a reliable demand for novel and effective clinical trial software to accelerate drug development processes.
- For Instance, In September 2025, IQVIA, a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries, announced the launch of its Clinical Trial Financial Suite (CTFS), an AI-enabled platform orchestrating all financial aspects of clinical trials. CTFS is designed to eliminate inefficiencies created by siloed systems and fragmented processes.
The U.S. has a strong foundation in digital and cloud-driven infrastructure, which is significant for modern, data-intensive healthcare research. The U.S. leads in adopting novel technologies such as machine learning, AI, and real-world data (RWD) for trial optimization and matching. The U.S. is at the forefront of accepting decentralized and patient-centric healthcare trial models, which need sophisticated software for remote data management and monitoring.
How did the Asia Pacific Grow Notably in the Market in 2024?
The Asia Pacific region is the fastest-growing in the clinical trials support software solutions market, as Governments are streamlining approval procedures, using rapid designations for some drugs. Financial support and public-private collaboration are inspiring more clinical research in the region. The growing acceptance of digital health innovations, the incorporation of real-world data, and decentralized trial models is driving more complex research.
Segmental Insights
By Product Analysis
Which Product Led the Clinical Trials Support Software Solutions Market in 2024?
The clinical trial management system substance segment accounted for the dominating share of the market in 2024, as a specialized software designed to streamline the tracking, planning, and management of clinical trials. It integrates all trial-associated data, confirming efficient data management, government compliance, and improving partnering among the stakeholders. Improved precision of data lowers the administrative burdens, optimizes patient recruitment and retention, and significant charge savings.
Whereas the payments/investigator payments solutions segment is predicted to register rapid expansion in the forecasting period, as it is an elastic technology that has been recognized to permit the most complex trial designs. CTFS site payments are authorized to manage clinical trial site payments by a hybrid model. AI-driven invoice ingestion, validation, irregularity identification, and global tax compliance.
By Delivery Mode Analysis
Which delivery mode segment dominates the market in 2024?
In 2024, the cloud and web-based segment captured the biggest share of the clinical trials support software solutions market, as cloud-based clinical trial software solutions are growing in medical care management effectiveness and data accessibility. Cloud-based services permit access to healthcare records, appointment scheduling, and other significant data from any device with an internet connection. It allows greater partnership among healthcare providers.
Although the on-premises segment will expand fastest during 2025-2034, as on-premise services efficiently help clinical trial randomization and supply management. On-premises often needs purchasing and installing novel infrastructure or hardware. On-premise setups are constructed for a static capacity.
By Phase Analysis
Which phase segment dominates the Market in 2024?
The phase III segment held the biggest share of the clinical trials support software solutions market in 2024, as phase III trials goal to capture a wider representation of the population that benefits from the medicine. Phase III trials offer the massive amount of data required for the package insert and labelling of a drug. Phase III trials are to validate and ensure the initial evidence collected in the previous trials that the drug is a beneficial, safe, and efficient treatment for the designated indication.
Although the Phase I segment will expand fastest during 2025-2034, as Phase 1 clinical trials are a vital component of assessing services and products, including drugs and drug combinations. Phase I trials are done to find the uppermost dose of a novel treatment that given safely without causing multifaceted side effects.
By End Use Analysis
Which end-use segment dominates the market in 2024?
The contract research organizations (CROs) segment held the biggest share of the clinical trials support software solutions market in 2024, as contract research organizations are appointed to provide research support and conduct clinical trials to efficiently and safely bring life-saving drugs and vaccines. CRO conducting trials ensures the trial meets timelines and maintains quality values. Clinical trial software supports sponsors and CROs to cooperate by enabling them to share documents, protocols, and data instantly.
Although the biopharmaceutical companies’ segment will expand fastest during 2025-2034, as clinical trial software enhances the accuracy of data, which has a direct effect on patient results. With electronic data capture (EDC) capacity, it removes the challenges of errors related to manual data entry. Clinical trial software drives seamless association among the different stakeholders involved in a clinical trial, including clinicians, researchers, sponsors, and patients.
Clinical Trials Support Software Solutions Market Value Chain Analysis
1. Software Development & Innovation
This stage involves the design, development, and continuous improvement of clinical trials support software solutions, including CTMS, EDC, and payment systems. Companies invest heavily in R&D to enhance functionalities such as data security, usability, and compliance with regulatory standards.
- Key players: Medidata Solutions, Oracle Corporation, Veeva Systems, Parexel International.
2. Clinical Trial Planning & Management
In this stage, the software is used to streamline trial design, protocol development, site selection, and resource management. Effective clinical trial management software (CTMS) helps optimize timelines and reduce costs by improving operational efficiency.
- Key players: IBM Watson Health, Medidata Solutions, BioClinica.
3. Data Collection & Monitoring
Electronic Data Capture (EDC) and remote monitoring tools facilitate accurate, real-time data collection and management during trials. This stage ensures data integrity, minimizes errors, and accelerates decision-making for sponsors and CROs.
- Key players: Oracle Corporation, Medidata Solutions, Castor EDC.
4. Payment & Investigator Management
Payment solutions automate and track financial transactions, ensuring timely and accurate payments to investigators and sites. This improves transparency, compliance, and investigator engagement throughout the trial.
- Key players: Clinical Conductor, TrialPay, Medidata.
5. Regulatory Compliance & Reporting
Software solutions support compliance with regulatory requirements by facilitating audit trails, reporting, and secure data handling. This stage is critical to ensure trials meet global standards such as FDA, EMA, and ICH-GCP guidelines.
- Key players: Veeva Systems, Oracle Corporation, Medidata Solutions.
6. Post-Trial Data Analysis & Reporting
After data collection, advanced analytics and reporting tools provide insights for decision-making, publication, and regulatory submissions. This stage helps stakeholders understand trial outcomes and plan future studies.
- Key players: IBM Watson Health, SAS Institute, Medidata Solutions.
Clinical Trials Support Software Solutions Market Companies
1. Medidata Solutions
It provides a comprehensive suite of cloud-based clinical trial management software including CTMS, EDC, and patient engagement tools. Medidata’s platforms enhance trial efficiency, data accuracy, and regulatory compliance, making it a preferred choice among pharmaceutical companies and CROs.
2. Oracle Corporation
Oracle offers a broad range of clinical trial software solutions such as Oracle Health Sciences Clinical One platform that integrates data management, CTMS, and safety systems. Oracle’s solutions support scalable and secure clinical trials worldwide, helping sponsors accelerate drug development.
3. Veeva Systems
The company specializes in cloud-based software for clinical data management and regulatory compliance. Veeva’s Vault Clinical Suite streamlines clinical trial operations and ensures data integrity with robust regulatory compliance features, widely adopted by biopharma companies.
4. IBM Watson Health
It leverages AI and analytics to optimize clinical trial design, patient recruitment, and data analysis. IBM Watson Health’s solutions help reduce trial timelines and costs by enabling smarter decision-making through advanced data insights.
5. Parexel International
It provides both clinical research services and proprietary trial management software. Parexel’s technology supports end-to-end trial management, offering customized solutions that improve operational efficiency and regulatory adherence.
6. BioClinica
The company offers integrated clinical trial software and imaging solutions, focusing on data collection and monitoring. BioClinica’s platforms facilitate remote monitoring and data analytics, enhancing trial transparency and data quality.
7. Castor EDC
Castor EDC is known for user-friendly electronic data capture (EDC) software that simplifies data collection and management for clinical trials. Castor’s cloud-based solutions enable real-time access to trial data and compliance with global regulations.
8. Clinical Conductor
It specializes in investigator payment and financial management solutions, automating payments and enhancing transparency. This improves site engagement and reduces administrative burdens in clinical trials.
9. SAS Institute
It provides advanced analytics and reporting software that supports post-trial data analysis and regulatory submissions. SAS’s solutions enable sponsors to derive actionable insights and ensure compliance with industry standards.
Recent Developments
- In October 2025, Florence Healthcare, the leading clinical trial platform connecting pharmaceutical sponsors and research sites worldwide, announced that SiteLink, a key provider of Florence’s Trial Operations Platform, is now available in AWS Marketplace.
- In October 2025, Verana Health, a digital health company devoted to transforming patient care and clinical research through real-world data (RWD), revealed several novel enhancements to data and software solutions designed to enhance real-world insights and expedite treatment options in ophthalmology.
- In January 2025, Advarra, the market leader in regulatory review solutions and clinical research technology, unveiled its Study Collaboration solution to accelerate study startup by automating workflows, improving real-time visibility, and fostering seamless collaboration and engagement among research stakeholders.
More Insights in Nova One Advisor:
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- U.S. Cell And Gene Therapy Clinical Trials Market – The U.S. cell and gene therapy clinical trials market size is calculated at USD 5.35 billion in 2024, grows to USD 5.92 billion in 2025, and is projected to reach around USD 14.68 billion by 2034, growing at a CAGR of 15.62% from 2025 to 2034.
- Cell And Gene Therapy Clinical Trials Market – The global cell and gene therapy clinical trials market size reached USD 15.85 billion in 2024 and is projected to hit around USD 64.74 billion by 2034, expanding at a CAGR of 15.11% during the forecast period from 2025 to 2034.
- Asia Pacific Clinical Trials Market – The Asia Pacific clinical trials market size is calculated at USD 17.45 billion in 2024, grows to USD 18.93 billion in 2025, and is projected to Hit around USD 39.38 billion by 2034, growing at a CAGR of 8.48% from 2025 to 2034.
- Pediatric Clinical Trials Market – The pediatric clinical trials market size was exhibited at USD 19.75 billion in 2024 and is projected to hit around USD 33.01 billion by 2034, growing at a CAGR of 5.27% during the forecast period 2025 to 2034.
- U.S. Clinical Trials Market – The U.S. clinical trials market size was valued at USD 40.85 billion in 2024 and is projected to surpass around USD 75.39 billion by 2034, registering a CAGR of 6.32% over the forecast period of 2025 to 2034.
- U.S. Artificial Intelligence In Healthcare Market – The U.S. artificial intelligence in healthcare market size was exhibited at USD 13.75 billion in 2024 and is projected to hit around USD 315.16 billion by 2034, growing at a CAGR of 36.78% during the forecast period 2025 to 2034.
- Europe Clinical Trials Market – The Europe clinical trials market size was exhibited at USD 22.25 billion in 2024 and is projected to hit around USD 43.00 billion by 2034, growing at a CAGR of 6.81% during the forecast period 2025 to 2034.
- India Clinical Trials Market – The India clinical trials market size was exhibited at USD 1.55 billion in 2024 and is projected to hit around USD 3.38 billion by 2034, growing at a CAGR of 8.1% during the forecast period 2024 to 2034.
- RNA Therapy Clinical Trials Market – The RNA therapy clinical trials market size was exhibited at USD 2.85 billion in 2024 and is projected to hit around USD 4.16 billion by 2034, growing at a CAGR of 3.85% during the forecast period 2024 to 2034.
- Virtual Clinical Trials Market – The global virtual clinical trials market size was exhibited at USD 8.85 billion in 2023 and is projected to hit around USD 15.70 billion by 2033, growing at a CAGR of 5.9% during the forecast period 2024 to 2033.
- HIV Clinical Trials Market – The HIV clinical trials market size was exhibited at USD 1.30 billion in 2024 and is projected to hit around USD 2.42 billion by 2034, growing at a CAGR of 6.4% during the forecast period 2024 to 2034.
Segments Covered in the Report
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2034. For this study, Nova one advisor, Inc. has segmented the global clinical trials support software solutions market.
By Product
- Electronic Clinical Outcome Assessment (eCOA) / ePRO)
- Electronic Data Capture (EDC) & CDMS
- Clinical Analytics Platforms
- Clinical data integration platforms
- Safety solutions
- Clinical Trial Management System (CTMS)
- Randomization and Trial Supply Management (RTSM)
- Electronic Trial Master File (eTMF)
- eConsent
- Payments / Investigator Payments Solutions
- Electronic Investigator Site File (eISF)
- Patient Matching / Feasibility Solutions
By Delivery Mode
- Cloud and Web Based
- On-Premise
By Phase
- Phase I
- Phase II
- Phase III
- Phase IV (Post-marketing)
By End Use
- Hospitals/Healthcare Providers/Healthcare providers
- Contract Research Organizations (CROs) (R&D covered)
- Academic & Research Institutions
- Pharmaceutical Companies
- Biopharmaceutical Companies
- Medical Device Companies
By Regional
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East and Africa (MEA)
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