e-Consent Market Intelligence

*This report was last updated in Q4 2018. Please click on request customization if you are looking for an updated version of this report

Report Coverage

  • Supplier Landscape
  • Mergers and Acquisitions
  • Benchmark Timelines and KPI
  • Evolving Supply Market to Manage GDPR Impact

Approximately 66 percent of the top 50 pharma are engaged in or are planning to adopt an Electronic Informed Consent Form (e-ICF) or e-Consent initiative in the near future with most of the top 10 pharma already having an e-Consent strategy in place. In 3 years from now, e-Consent is expected to be used in more than 75 percent of clinical trials, with 94-96 percent of patients already preferring e-Consent. The flexible device approach is predicted to have the highest rate of adoption of 65 percent in 3-5 years, followed by a 60 percent adoption rate of mutual recognition training. ..

The report provides a comprehensive analysis of the e-Consent market, the factors affecting the market, and methods to improve e-Consent adoption by Pharma. The report examines current and future trends in the e-Consent market, along with a SWOT analysis. The report identifies the industry best practices and benchmarks on service offerings, with relevant case studies. Opportunities for different stakeholders are evaluated in the report, and the regulatory landscape in the U.S. and EU applicable to e-Consent are discussed. The report also includes a detailed supplier analysis with supplier landscape and relevant selection criteria and analysis of major collaborations by suppliers.

Beroe gathers intelligence through primary sources that include industry experts, researchers, and consultants, as well as current suppliers, producers and distributors. Secondary sources can include business journals, newsletters, magazines, market research data, company sources, and industry associations. Following data collation, analysis, and strategic review, the Final Research Report is published on Beroe LiVE.

Table of contents

  1. e-Consent Executive Summary
  2. Executive Summary
  1. e-Consent Market Analysis
  2. Market Overview
  3. Factors Impacting the Market
  4. Current and Future Trends
  5. SWOT
  6. KPI and Benchmark on Service Offering
  1. e-Consent Regulatory Landscape
  2. Regulatory Landscape ( US and EU)
  1. e-Consent Supplier Analysis
  2. Supplier Landscape
  3. Mergers and Acquisitions
  4. Benchmark Timelines and KPI
  5. Evolving Supply Market to Manage GDPR Impact
  1. e-Consent Industry Best Practice and Case Studies
  2. Industry Best Practice
  3. Opportunities for Different Stakeholders
  4. Case Studies

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Global Market Outlook on e-Consent

Although historically there has been challenges in adopting to e-Consent platform, currently there is shift in the industry. Most of the top 10 Pharma have incorporated in almost 60 percent of their trials. Buyers who were adopting at a rate of 10-11 percent last year are turning to a higher percent of adoption, close to 21-23 percent now.


Suppliers are collaborating with technology providers and amongst themselves to promote site and patient acceptance to e-Consent. Existing and new suppliers are broadening their scope of their service to align themselves to the industry shift and demand.

  • 66% of top 50 pharma are engaged or are planning to adopt to an e-Consent initiative in the near future. Most of the top 10 pharma already have an e-Consent strategy in place.
  • It is expected that, there will be a big difference when it comes to the shift in technology in the next 12 months. However, three years from now, more than 50% of the clinical trials will be adapting to e-Consent
  • Users feel the major value derived out of design and development functionalities is the use of smart devices followed by the easy content creation. This is mainly because the ability of developing a solution without vendor involvement has always been an area of worry for the stakeholders
  • Virtual care is increasingly becoming a common area of interest, as it opens a world full of possibilities for exchange of patient information.It also helps provide timely entry of any e-Informed Consent data and also for collecting subject's consent from remote locations

Factors Impacting the Market

  • Several barriers that constrain the shift to an e-ICF mode from paper can be managed effectively, by understanding the adoption hurdles and by anticipating how the market is growing in future.
  • With the advent of virtual trials and BYOD in clinical trials, remote consent is emerging as an important topic. Patients want to use information in the comfort zone, taking the time to think and discuss with their family.


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