Electronic Informed Consent (eConsent)
Transform your informed consent process with a digital-first platform that enhances patient understanding through multimedia content delivery, interactive comprehension assessments, and secure electronic signature capture. Our eConsent solution supports both on-site and remote consent workflows, ensuring regulatory compliance while improving the participant experience across global clinical trials.
Reimagining Informed Consent for Modern Trials
Traditional paper-based consent processes create barriers to patient understanding and introduce operational inefficiencies across multi-site clinical trials. Our eConsent platform replaces static paper documents with an interactive, multimedia-rich digital experience that adapts to each participant's needs.
Purpose-built for regulated clinical environments, the platform delivers consent information through videos, animations, and interactive diagrams while capturing comprehension data at every step. With built-in version management, multi-language support, and seamless IRB/Ethics Committee integration, eConsent ensures every consent interaction is compliant, documented, and audit-ready.
Comprehensive eConsent Features
Our eConsent platform provides a complete digital informed consent solution with six core capability areas designed to enhance patient understanding, streamline site workflows, and ensure full regulatory compliance.
Multimedia Content Delivery
Deliver consent information through rich, interactive media that adapts to participant learning preferences and improves comprehension of complex trial procedures.
- Embedded educational videos
- Interactive animations and diagrams
- Layered information architecture
- Accessible content formatting
Comprehension Checks
Verify patient understanding before consent is captured through configurable knowledge assessments that ensure truly informed participation.
- Configurable knowledge assessments
- Interactive quizzes per section
- Understanding verification scoring
- Re-education workflows on failure
Remote Consent
Enable secure remote eConsent workflows that extend trial reach while maintaining the rigour and compliance of in-person consent processes.
- Secure remote consent workflows
- Identity verification protocols
- Legally Authorised Representative support
- Remote witness capabilities
Version Management
Maintain complete control over ICF versions with automated tracking, re-consent workflows, and full amendment history across all sites.
- Automated ICF version control
- Re-consent workflow triggers
- Amendment tracking and history
- Site-level version deployment
Multi-Language Support
Deploy consent materials across global trial sites with integrated translation management and locale-specific content delivery.
- Multiple language configurations
- Translation management workflows
- Locale-specific formatting
- Global trial deployment support
IRB/EC Integration
Streamline the approval lifecycle with integrated Ethics Committee submission workflows and real-time approval status tracking.
- Streamlined approval workflows
- Document submission management
- Approval tracking dashboards
- Conditional approval handling
Benefits by Role
Our eConsent platform delivers targeted value for every stakeholder in the clinical trial ecosystem, from sponsor oversight to site-level patient interactions.
Sponsors
- Regulatory compliance assurance with 21 CFR Part 11 and ICH-GCP adherence
- Complete consent audit trail for inspection readiness
- Protocol amendment management with automated re-consent tracking
- Real-time consent status visibility across all sites and countries
- Reduced consent-related protocol deviations
CROs
- Multi-study consent management from a single unified platform
- Standardised consent workflows deployable across programmes
- Site training tools and onboarding materials for rapid activation
- Cross-study consent analytics and performance benchmarking
- Scalable infrastructure for concurrent global trials
Site Teams
- Simplified consent process with guided step-by-step workflows
- Patient-friendly interface with accessible multimedia content
- Real-time consent status tracking per participant
- Automated notifications for re-consent requirements
- Reduced administrative burden with digital document management
Integrated with Your Clinical Ecosystem
Our eConsent platform does not operate in isolation. It connects seamlessly with the broader MTK clinical technology suite, enabling automated data flow, unified participant records, and operational efficiency across your entire trial infrastructure.
EDC Integration
Bi-directional data exchange with our EDC platform ensures consent status is automatically reflected in participant records and eligibility checks.
CTMS Connectivity
Real-time consent metrics feed directly into CTMS dashboards for site performance monitoring, milestone tracking, and enrolment analytics.
DocuVault eTMF
Signed consent documents are automatically filed into the Trial Master File with correct metadata, version tagging, and DIA TMF Reference Model classification.
ePRO / eCOA
Consent status gates participant access to ePRO assessments, ensuring only consented participants receive electronic questionnaires and diary prompts.
Why Choose MTK eConsent
Built on deep regulatory expertise and clinical operations experience, our eConsent platform delivers the compliance, usability, and integration that modern trials demand.
Regulatory-First Design
Built from the ground up for 21 CFR Part 11 compliance, GDPR adherence, and ICH-GCP E6(R2) alignment with comprehensive validation documentation.
Patient-Centric Experience
Intuitive, accessible interface designed around participant needs with multimedia content, adjustable text sizes, and support for diverse literacy levels.
Unified Ecosystem
Native integration with EDC, CTMS, DocuVault, and ePRO eliminates data silos, reduces manual reconciliation, and ensures a single source of truth.
Rapid Deployment
Configurable templates and standardised workflows enable rapid study setup, reducing time from protocol approval to first patient consent.
See eConsent in Action
Schedule a personalised demonstration to discover how our eConsent platform can transform your informed consent process, enhance patient understanding, and streamline regulatory compliance across your clinical programme.