US eClinical Solutions Market

The report "US eClinical Solutions Market by Product (CDMS, EDC, CTMS, eCOA, RTSM, eTMF, RIMS,   eConsent), Application (Collection, Operation, Analytics), Trial Phase, End User (CRO, Pharma, Biotech, Medtech), Regulatory, AI, Growth, Market Size - Forecast to 2030" is projected to grow from USD 5.99 billion in 2025 and to reach USD 11.64 billion by 2030, at a Compound Annual Growth Rate (CAGR) of 14.2% during the forecast period.

Browse 121 market data Tables and 51 Figures spread through 250 Pages and in-depth TOC on "US eClinical Solutions Market by Product (CDMS, EDC, CTMS, eCOA, RTSM, eTMF, RIMS,   eConsent), Application (Collection, Operation, Analytics), Trial Phase, End User (CRO, Pharma, Biotech, Medtech), Regulatory, AI, Growth, Market Size - Forecast to 2030"
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The growing reliance on electronic health records for trial feasibility is accelerating the adoption of eClinical solutions in the US. Sponsors need platforms that securely integrate and analyze patient-level data to improve site selection and eligibility accuracy. Pressure to shorten database lock timelines is also prompting organizations to adopt advanced EDC and centralized review tools. These tools reduce queries and improve real-time data quality. Together, these factors strengthen demand for integrated, automation-enabled clinical data management systems.

The pharmaceutical and biopharmaceutical companies segment accounted for the largest share of the US eClinical solutions market, by end user, in 2024.

By end user, the pharmaceutical and biopharmaceutical companies segment held the largest share of the market in 2024 due to the scale and complexity of clinical programs in the US. These companies run high-volume oncology, immunology, and rare disease trials that require advanced EDC, CTMS, and analytics platforms. Their adoption of decentralized and hybrid models is increasing the use of validated eConsent, ePRO, and remote monitoring tools. This reliance also positions pharma and biopharma as the most technology-dependent buyers in the US eClinical solutions market.

The Phase IV trial phase is expected to show the fastest growth in the US eClinical solutions market, by clinical trial phase, during the forecast period.

By clinical trial phase, Phase IV is expected to grow at the fastest rate during the forecast period due to expanding post-marketing evidence requirements in the US. The FDA requires certain post-approval studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to assess known or potential safety risks. This requirement is increasing the number of safety-focused and real-world performance trials. Sponsors must also comply with ongoing surveillance and reporting obligations under FDA post-marketing programs. These expectations are driving the adoption of eClinical platforms that support real-time safety monitoring, long-term patient follow-up, and integration with real-world data sources.

The data collection segment held the largest share of the US eClinical solutions market in 2024, by application.

By application, data collection held the largest share of the market in 2024, driven by the high number of FDA-regulated clinical trials happening in the US, demanding precise, audit-compliant datasets. The pharmaceutical and biotech industries are increasingly utilizing sophisticated electronic data capture, eSource, and remote data capture technologies to manage the high volumes of clinical trial data resulting from complex trials for cancer, immunological disorders, and rare diseases. The rapid growth in decentralized trials and hybrid trials further drives the need for solutions that can abstract patient information collected through telemedicine, home healthcare evaluations, wearable devices, and digital health technologies. This trend further emphasizes the value of traceable, high-throughput, and highly compliant, validated data collection solutions for clinical trials to meet strict 21 CFR Part 11 regulatory requirements.

Key Players

The report profiles key players such as Medidata (A Dassault Systèmes Company) (France), Veeva Systems (US), IQVIA Inc. (US), Icon Plc (Ireland), Signant Health (US), Clario (US), Eclinical Solutions Llc (US), Oracle (US), and Clinion (US), among others.

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