EConsent In Healthcare Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Platform (Cloud-based, Web-based), By Enrollment Type (On-site, Remote), By Form Type ( General Consent, General Consent with Specific Denial(s), General Denial with Specific Consent(s), General Denial), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 372.89 Million
CAGR (2026-2031)	12.19%
Fastest Growing Segment	Cloud-based
Largest Market	North America
Market Size (2031)	USD 743.54 Million

Market Overview

The Global EConsent In Healthcare Market is projected to grow from USD 372.89 Million in 2025 to USD 743.54 Million by 2031 at a 12.19% CAGR. The Global EConsent In Healthcare Market comprises digital platforms designed to modernize the informed consent process by utilizing multimedia components and electronic signatures to educate patients and secure their voluntary participation in clinical trials. The primary drivers propelling this market include the urgent industry demand for patient-centric trial designs and the increasing regulatory support for decentralized clinical trials which necessitate remote enrollment capabilities. According to the Association of Clinical Research Professionals, in 2025, 73% of clinical research professionals predicted that technology providers would generate the most positive impact on the clinical research enterprise over the next decade. This strong confidence from industry stakeholders highlights the critical role that digital adoption plays in streamlining study operations and improving data compliance.

Nevertheless, a significant challenge hindering broader market expansion is the technical complexity of integrating eConsent systems with existing research site infrastructures. The lack of seamless interoperability between new digital consent tools and legacy electronic health record systems frequently results in data silos and increased administrative burdens for site staff, thereby slowing the overall implementation of these technologies.

Key Market Drivers

The proliferation of Decentralized and Hybrid Clinical Trials (DCTs) acts as a primary catalyst for the adoption of eConsent solutions, fundamentally reshaping how researchers engage with participants across geographically dispersed locations. As the industry moves away from traditional site-anchored models, electronic consent platforms have become essential for enabling remote enrollment and ensuring continuous compliance without physical visits. This shift is strongly supported by site preferences for flexible operational models that reduce administrative burdens. According to the Tufts Center for the Study of Drug Development (Tufts CSDD), March 2024, in the 'Tufts CSDD: New Insights on The Clinical Trial Industry' article, 61.4% of investigative sites expressed a preference for hybrid or fully decentralized trial models, underscoring the necessity for digital tools. Consequently, eConsent systems are increasingly integrated into study protocols to bridge the gap between remote participants and research investigators.

Simultaneously, the rising emphasis on patient-centricity and comprehension is driving the market, as stakeholders prioritize tools that enhance the participant's understanding of complex medical information through interactive multimedia. Unlike static paper forms, digital platforms offer videos and tiered information delivery that empower patients to make truly informed decisions, directly improving retention rates. According to OpenClinica, May 2024, in the 'Four Ways to Strengthen Patient Engagement in Clinical Trials' article, 61% of respondents found eConsent forms "very easy" to understand, demonstrating a clear superiority over traditional methods. This user-friendly approach significantly improves the participant experience and accelerates broader technology adoption. Reflecting this rapid market uptake, according to Florence Healthcare, in 2024, the industry witnessed a threefold increase in the use of eConsent platforms since 2020, signaling a robust transition toward digital-first engagement strategies.

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Key Market Challenges

The technical complexity of integrating eConsent systems with existing research site infrastructures constitutes a substantial barrier to the expansion of the Global EConsent In Healthcare Market. Although digital consent tools are designed to facilitate remote enrollment, they frequently lack seamless interoperability with legacy Electronic Health Record (EHR) systems already established within hospitals and clinical centers. This connectivity gap creates significant data silos, forcing research personnel to manage disconnected workflows rather than enjoying the efficiency of a unified ecosystem. Consequently, the operational friction caused by these integration failures deters research sites from fully adopting eConsent platforms, as the technology often complicates rather than simplifies site operations.

This fragmentation directly impedes market growth by imposing excessive administrative burdens on clinical trial staff, who must bridge these technical gaps manually. According to the Association of Clinical Research Professionals, in 2025, approximately 60% of research site staff reported that they regularly performed redundant data entry tasks due to unintegrated clinical technologies. This high level of manual duplication not only increases the risk of transcription errors but also consumes critical time that could be allocated to patient care. As a result, many stakeholders resist implementing standalone eConsent solutions, limiting the broader scalability of the market.

Key Market Trends

The Integration of Artificial Intelligence for Patient Comprehension Analysis is emerging as a critical trend, shifting the focus from simple digital presentation to active, real-time understanding verification. Unlike static multimedia, AI-driven algorithms and Natural Language Processing (NLP) now assess participant literacy levels during the consent process, automatically adapting complex medical terminology into accessible language to ensure true informed decision-making. This capability is becoming increasingly vital as protocols grow in complexity, yet the technology remains in the early stages of broad deployment. According to Applied Clinical Trials Online, June 2025, in the 'New Insights On the Impact of AI-Enabled Solutions' article, only 11% of the nearly 80 companies responding reported fully implementing AI/ML to enable and support clinical trial activities, indicating significant potential for market growth as these sophisticated comprehension tools mature.

Simultaneously, the market is witnessing a Convergence with Electronic Health Records and eClinical Systems to dismantle the operational silos that currently burden research sites. Stakeholders are aggressively moving towards unified ecosystems where eConsent platforms interoperate seamlessly with existing site technology, enabling Single Sign-On (SSO) and automated data flow into patient records. This trend is a direct response to the overwhelming administrative workload caused by disparate systems, pushing vendors to prioritize integration over standalone functionality. This demand for operational efficiency is underscored by recent data; according to Greenphire, October 2024, in the 'Annual Market Trends Survey', 95% of sites emphasize the importance of reduction of effort and time spent on a task in technology supporting their clinical trial, driving the rapid adoption of these interconnected eClinical environments.

Segmental Insights

The Cloud-based segment is currently recognized as the fastest-growing category within the Global EConsent In Healthcare Market. This rapid expansion is primarily driven by the widespread adoption of decentralized clinical trials, which require secure and real-time access to patient data across diverse geographical locations. Cloud solutions offer superior scalability and cost-efficiency compared to on-premise alternatives, allowing research organizations to deploy studies quickly without heavy infrastructure investment. Furthermore, regulatory bodies such as the US Food and Drug Administration have issued guidance supporting electronic data capture, increasing industry confidence in cloud-deployed systems for maintaining compliance and data integrity.

Regional Insights

North America maintains the leading position in the global eConsent in healthcare market due to the high concentration of clinical trials conducted within the region. This dominance is largely driven by supportive regulatory initiatives from the US Food and Drug Administration, which actively encourage the adoption of electronic informed consent to enhance patient comprehension and compliance. Furthermore, the strong presence of major pharmaceutical and biotechnology companies facilitates the integration of digital tools into research workflows. This favorable environment supports the widespread implementation of electronic consent solutions across the regional healthcare sector.

Recent Developments

• In September 2024, uMotif completed the strategic acquisition of ClinOne, a provider of technology solutions for clinical trial sites, effectively combining their capabilities in the global eClinical market. This move allowed uMotif to integrate ClinOne’s electronic informed consent technology into its existing patient-centric platform, which already included electronic clinical outcome assessments. The collaboration aimed to create a unified solution that simplified the trial experience for both patients and research sites. By offering a seamless interface for consent and data capture, the company sought to improve participant engagement, reduce site burden, and ensure higher data quality in complex clinical studies.
• In September 2024, Signant Health entered into a significant collaboration with IQVIA by joining the "One Home for Sites" initiative. This partnership enabled the integration of Signant’s "SmartSignals" unified platform, which encompasses electronic informed consent and other evidence-generation tools, into IQVIA’s single-sign-on dashboard for research sites. The objective of this cooperation was to reduce the technology burden on site staff by centralizing access to multiple clinical trial applications from different providers. Through this interoperability, the companies aimed to streamline site workflows, enhance the efficiency of study conduct, and facilitate a smoother, more connected experience for investigators managing global healthcare trials.
• In March 2024, Suvoda LLC announced the launch of the latest version of its electronic informed consent solution, designed to significantly improve the patient journey in clinical trials. The enhanced platform featured new functional capabilities such as embedded educational videos, frequently asked questions, and glossary definitions directly within the consent documents. These updates aimed to increase patient comprehension and decision-making confidence while providing sponsors with greater visibility and control over the consent process across global studies. The company emphasized that these product advancements were developed to streamline operations for study sites and reduce the administrative burden often associated with traditional paper-based consent methods.
• In February 2024, Medable Inc. collaborated with Duke University's Department of Population Health Sciences to publish breakthrough research regarding electronic informed consent in the healthcare sector. The study, conducted by the Bioethics and Stakeholder (BASE) Lab, evaluated participant comprehension and preference for enhanced eConsent forms compared to traditional text-only versions. Results indicated that a significant majority of patients found the digital, interactive elements—such as videos and knowledge checks—more informative and engaging than paper equivalents. This research highlighted the critical role of advanced eConsent technologies in improving patient understanding and retention in clinical trials, validating the industry's shift towards patient-centric digital methodologies.

Key Market Players

• Veeva Systems Inc.
• Magentus Software Limited
• Florence Healthcare Inc.
• Concentric Health Ltd
• 5thPort, LLC
• Cloudbyz Inc.
• Calysta EMR
• Interlace Health, LLC
• Thieme Compliance GmbH
• OpenClinica, LLC

By Platform	By Enrollment Type	By Form Type	By Region
Cloud-based Web-based	On-site Remote	General Consent General Consent with Specific Denial(s) General Denial with Specific Consent(s) General Denial	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global EConsent In Healthcare Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• EConsent In Healthcare Market, By Platform:

• Cloud-based
• Web-based

• EConsent In Healthcare Market, By Enrollment Type:

• On-site
• Remote

• EConsent In Healthcare Market, By Form Type:

• General Consent
• General Consent with Specific Denial(s)
• General Denial with Specific Consent(s)
• General Denial

• EConsent In Healthcare Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE