eConsent in Clinical Trials Research:the global market size is projected to reach USD 0.65 billion by 2031

QY Research Inc. (Global Market Report Research Publisher) announces the release of 2025 latest report "eConsent in Clinical Trials- Global Market Share and Ranking, Overall Sales and Demand Forecast 2025-2031". Based on current situation and impact historical analysis (2020-2024) and forecast calculations (2025-2031), this report provides a comprehensive analysis of the global eConsent in Clinical Trials market, including market size, share, demand, industry development status, and forecasts for the next few years.

The global market for eConsent in Clinical Trials was estimated to be worth US$ 240 million in 2024 and is forecast to a readjusted size of US$ 647 million by 2031 with a CAGR of 14.8% during the forecast period 2025-2031.

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eConsent in Clinical Trials Market Summary

In August 2023, the U.S. Food and Drug Administration (FDA) issued the latest guidance on informed consent, explicitly supporting the widespread adoption of electronic informed consent (eConsent) in clinical trials. The guidance emphasizes that eConsent not only meets regulatory requirements but also enhances participant comprehension and engagement, particularly in remote or multi-center studies.

Additionally, the FDA released a "Questions and Answers Guide on the Use of Electronic Informed Consent," providing research institutions with practical recommendations on ensuring the compliance of electronic signatures, securing data storage, and presenting necessary documentation during audits and inspections. These guidelines offer clear policy support and practical direction for clinical researchers and institutions implementing eConsent.

Against this policy backdrop, QYResearch latest research report provides an in-depth analysis of the current applications, challenges, and future development trends of eConsent technology.

eConsent in clinical trials is a digitalized approach to obtaining and managing informed consent, wherein potential participants use electronic media-such as interactive platforms, videos, or quizzes-to thoroughly review and acknowledge study information. This process enhances comprehension, supports ongoing reconfirmation of consent, and can be administered either remotely or on-site, thereby improving transparency, efficiency, and regulatory compliance throughout the trial.

According to the new market research report "Global eConsent in Clinical Trials Market Report 2025-2031", published by QYResearch, the global eConsent in Clinical Trials market size is projected to reach USD 0.65 billion by 2031, at a CAGR of 14.8% during the forecast period.

Market Development Opportunities & Main Driving Factors

The electronic informed consent (eConsent) market in clinical trials is experiencing unprecedented growth opportunities. Global pharmaceutical and biotechnology companies are accelerating digital transformation, particularly in multi-center and remote clinical trials, where eConsent significantly improves participant comprehension and enrollment efficiency while reducing the management cost of paper documents. Regulatory bodies, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), continue to release guidance supporting electronic informed consent, providing clear legal and compliance frameworks for adoption. Furthermore, with the advancement of cloud computing, big data, and mobile health technologies, eConsent platforms enable real-time, cross-regional data management and secure storage, driving the overall digitalization of the industry.

Market Challenges, Risks, & Restraints

Despite significant opportunities, the eConsent market faces multiple challenges and risks. Regulatory standards for electronic signatures, data security, and privacy protection vary across countries and regions, complicating system deployment and compliance. Technical integration issues, system compatibility, and cross-platform operational stability may also impact user experience and enterprise adoption. Additionally, high demands for platform customization and technical support from clinical trial institutions increase development costs, potentially squeezing supplier profit margins. Information security risks, such as data breaches and cyberattacks, remain critical concerns, requiring ongoing investment in research, development, and protection measures to maintain client trust.

Downstream Demand Trends

Downstream demand is increasingly focused on efficiency, digitalization, and personalization. Pharmaceutical companies, contract research organizations (CROs), and healthcare institutions are adopting interactive eConsent, mobile access, and multilingual support to enhance patient experience and regulatory compliance. The rise of remote, at-home, and decentralized clinical trials is also accelerating the adoption of eConsent. Looking forward, as digital health ecosystems mature and global regulatory convergence progresses, downstream demand for eConsent systems is expected to grow steadily, creating a stable and expanding market while driving innovation in related technologies and value-added services.

The report provides a detailed analysis of the market size, growth potential, and key trends for each segment. Through detailed analysis, industry players can identify profit opportunities, develop strategies for specific customer segments, and allocate resources effectively.

The eConsent in Clinical Trials market is segmented as below:
By Company
Signant Health
IQVIA
Medidata (Dassault Systèmes)
Advarra
Castor
ICON
Suvoda
Clinical Ink
EvidentIQ Group
JNPMEDI
Medable
uMotif
Veeva Systems
Medrio
Datacubed Health
Florence Healthcare
Trialogics
Xincere
Interlace Health
Tigermed
Climedo Health
CRScube
Cloudbyz
Obvio Health
Sano Genetics
Your Research (Almac Group)
RealTime eClinical Solutions
OpenClinica
Clinevo Technologies
Sitero
ResearchManager
Replior

Segment by Type
Interactive eConsent
Static eConsent

Segment by Application
Pharmaceutical & Biotech Companies
CROs
Hospitals & Research Centers
Others

Each chapter of the report provides detailed information for readers to further understand the eConsent in Clinical Trials market:

Chapter 1: Introduces the report scope of the eConsent in Clinical Trials report, global total market size (valve, volume and price). This chapter also provides the market dynamics, latest developments of the market, the driving factors and restrictive factors of the market, the challenges and risks faced by manufacturers in the industry, and the analysis of relevant policies in the industry. (2020-2031)
Chapter 2: Detailed analysis of eConsent in Clinical Trials manufacturers competitive landscape, price, sales and revenue market share, latest development plan, merger, and acquisition information, etc. (2020-2025)
Chapter 3: Provides the analysis of various eConsent in Clinical Trials market segments by Type, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different market segments. (2020-2031)
Chapter 4: Provides the analysis of various market segments by Application, covering the market size and development potential of each market segment, to help readers find the blue ocean market in different downstream markets.(2020-2031)
Chapter 5: Sales, revenue of eConsent in Clinical Trials in regional level. It provides a quantitative analysis of the market size and development potential of each region and introduces the market development, future development prospects, market space, and market size of each country in the world..(2020-2031)
Chapter 6: Sales, revenue of eConsent in Clinical Trials in country level. It provides sigmate data by Type, and by Application for each country/region.(2020-2031)
Chapter 7: Provides profiles of key players, introducing the basic situation of the main companies in the market in detail, including product sales, revenue, price, gross margin, product introduction, recent development, etc. (2020-2025)
Chapter 8: Analysis of industrial chain, including the upstream and downstream of the industry.
Chapter 9: Conclusion.

Benefits of purchasing QYResearch report:

Competitive Analysis: QYResearch provides in-depth eConsent in Clinical Trials competitive analysis, including information on key company profiles, new entrants, acquisitions, mergers, large market shear, opportunities, and challenges. These analyses provide clients with a comprehensive understanding of market conditions and competitive dynamics, enabling them to develop effective market strategies and maintain their competitive edge.

Industry Analysis: QYResearch provides eConsent in Clinical Trials comprehensive industry data and trend analysis, including raw material analysis, market application analysis, product type analysis, market demand analysis, market supply analysis, downstream market analysis, and supply chain analysis.

and trend analysis. These analyses help clients understand the direction of industry development and make informed business decisions.

Market Size: QYResearch provides eConsent in Clinical Trials market size analysis, including capacity, production, sales, production value, price, cost, and profit analysis. This data helps clients understand market size and development potential, and is an important reference for business development.

Other relevant reports of QYResearch:
Global eConsent in Clinical Trials Sales Market Report, Competitive Analysis and Regional Opportunities 2025-2031
Global eConsent in Clinical Trials Market Outlook, In‐Depth Analysis & Forecast to 2031
Global eConsent in Clinical Trials Market Research Report 2025
eConsent in Clinical Trials- Global Market Share and Ranking, Overall Sales and Demand Forecast 2025-2031
Global eConsent Clinical Trials Solution Market Outlook, In‐Depth Analysis & Forecast to 2031
Global eConsent Platforms for Clinical Trials Market Outlook, In‐Depth Analysis & Forecast to 2031

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