SITE TECHNOLOGY

eConsent

Make consenting simple

Advarra eConsent is an electronic informed consenting module for research sites. It’s designed to keep participants engaged, simplify compliance oversight, and optimize the overall quality of your consenting process.

Reduce Audit Findings While Increasing the Quality of Your Consent Process

Advarra eConsent helps your site reduce audit risk and keep participants engaged, while tracking consenting progress across your portfolio. eConsent is available as a module within Advarra’s eRegulatory Management System. 

Reduce Audit Findings While Increasing the Quality of Your Consent Process

Advarra eConsent helps your site reduce audit risk and keep participants engaged, while tracking consenting progress across your portfolio. eConsent is available as a module within Advarra’s eRegulatory Management System. 

Streamline Participant Engagement and Consent

Boost Engagement and Enrollment 

Offer participants and staff a seamless, user-friendly experience. Guided form templates simplify the process, allow participants to use any device, and don’t require a system-specific login, improving accessibility and engagement.

Efficiency and Compliance

Use standardized, 21 CFR Part 11 and HIPAA-compliant workflows with full audit trails to ensure compliance. Easily set up secure, remote monitoring sessions for internal monitors and sponsors, streamlining oversight and reducing the risk of errors.

Integrate Across Your Site

Integrate eConsent with Advarra’s CIRBI platform to ensure your team uses the latest informed consent forms. eConsent is also part of Advarra’s eReg system, which connects with Clinical Conductor and OnCore CTMS platforms.   

Paper vs eConsent

No Comparison

Audit Trail

Paper

  • No audit trail
  • Manual file system needed

eConsent

  • Complete audit trail for all signatures
  • Initials saved in a secure digital format
Version Control

Paper

  • Manual maintenance of version control
  • Error-prone process

eConsent

  • Strict version control
  • Automatic verification of most current version, patient delivery, and signature need notification
Storage

Paper

  • Numerous physical binders
  • Storage facility required

eConsent

  • Secure web portal
  • Data is backed up and accessible
Readiness of Site Consent Forms

Paper

  • Manual process to confirm readiness of forms

eConsent

  • Online summary of consent documentation
  • Remote viewing and reporting
  • Improved audit- and monitoring-readiness

Paper vs eConsent

No Comparison

Audit Trail

Paper

  • No audit trail
  • Manual file system needed

eConsent

  • Complete audit trail for all signatures
  • Initials saved in a secure digital format
Version Control

Paper

  • Manual maintenance of version control
  • Error-prone process

eConsent

  • Strict control
  • Automatic verification of most current version
  • Notification requirements for patient delivery and signature
Storage

Paper

  • Numerous physical binders
  • Storage facility required

eConsent

  • Secure web portal
  • Accessible
  • Data is backed up
Readiness of Site Consent Forms

Paper

  • Manual process to confirm readiness of forms

eConsent

  • Online summary of consent documentation
  • Remote viewing and reporting
  • Improved audit- and monitoring-readiness
Featured Content
eConsent Info Sheet
Info Sheet

eConsent Info Sheet

Advarra’s eConsent system is designed to enhance participant engagement while ensuring regulatory compliance through 21 CFR Part 11 standards.
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Connecting Patient Centricity and eConsent Together
Blog

Connecting Patient Centricity and eConsent Together

Patient-centric trial design, combined with eConsent, fosters better communication, comprehension, and retention, ensuring a smoother, more informed journey.
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Developing and Implementing a Successful eConsent Process
Blog

Developing and Implementing a Successful eConsent Process

A highly valuable tool for research staff, electronic consent (eConsent) can simplify the consenting process for both staff and participants.
Read More…
3 Must-Haves to Deploy Remote Clinical Trials
Blog

3 Must-Haves to Deploy Remote Clinical Trials

This blog covers three must-have decentralized trial tools to efficiently and compliantly implement remote modalities at your organization.
Read More…
Enhancing Research Conduct Using eConsent
Blog

Enhancing Research Conduct Using eConsent

eConsent in clinical trials enhances participant understanding and flexibility but requires careful planning, regulatory compliance, and IRB coordination to ensure success.
Read More…

A Purpose-built Clinical Research Cloud Platform

Built upon clinical research best practices, Advarra Cloud is a next-generation platform delivering applications in an easy-to-use, fully managed environment. Learn how the Cloud can help you automate, connect, and expedite processes across the clinical trial lifecycle.

Learn More

A Purpose-built Clinical Research Cloud Platform

Built upon clinical research best practices, Advarra Cloud is a next-generation platform delivering applications in an easy-to-use, fully managed environment. Learn how the Cloud can help you automate, connect, and expedite processes across the clinical trial lifecycle.

Learn More

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