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Reduce Audit Findings while Increasing the Quality of Your Consent Process

Advarra eConsent is a mobile friendly electronic consenting system that keeps participants engaged, enhances their understanding, simplifies compliance oversight, and optimizes the overall quality of the consenting process.

About eConsent

Reduce audit risk and boost participant retention with simple, interactive multimedia (text, video, hints, multi-language) to keep participants engaged, while the system tracks progress and conducts knowledge assessments to verify participant comprehension during the consenting process. By simplifying this process for staff with detailed analytics, remote access, and real-time alerts, sites gain significant improvements in consenting efficiency and a boost in ICF data quality.

Why eConsent?

Boost Participant Engagement
  • Ease participants through steps
  • Provide a multimedia experience
  • Allow participant device of choice

Enhance Consenting Compliance
  • Standardize the eSignature process
  • HIPAA and CFR Part 11 compliant
  • Allow participants to opt-out any time

Ensure Consent Process Efficiency
  • Standardize regulatory and personal forms
  • Provide consent versioning and audit trails
  • Automate reconsenting reminders

Increase Participant Enrollment
  • Comprehension focused consenting
  • Intuitive form templates
  • Complete process oversight

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Improve Participant Comprehension
  • Automate knowledge assessments
  • Provide hints for missed questions
  • Track progress and provide analytics

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Start Visit Procedures Faster
  • Quality checks during consenting
  • Increase patient comprehension
  • Controlled eSignature workflows

Paper Versus eConsent: A Comparison

There are many benefits of eConsent versus a paper-based system, especially when it comes to your study team being able to efficiently manage participant recruitment, maximize retention, mitigate the risk of data loss, and increase overall ROI.

Paper eConsent
Participant Engagement Site is responsible for participant understanding the forms they are handed Participant is engaged in an interactive process through video and Q&A
Fraud Detection No audit trail and manual file system needed Complete audit trail for all signatures, initials saved in a secure digital system
IRB Review Multiple circulating paper copies that vary by IRB and country Standardized documentation on web portal for IRB review
Version Control & Protocol Amendments Many patients don’t receive Strict version control with automatic patient delivery and signature notification
Site Monitoring Monitor travels to site All data easily accessible via secure web portal
Storage Numerous binders kept in a storage facility All data is accessible and backed up on secure web portal
Patient Comprehension Limited due to language, terminology, extent of documentation Available in multiple languages via the web from any location
Status of Site Consent Forms Must call, email, visit site to confirm status of forms Online summary viewing and reporting of all consent documentation

Increase Retention and Optimize Your Consenting Process