eConsent
eConsent
Enhance transparency, compliance, and participant engagement with eConsent, a digital solution designed to streamline and secure the informed consent process in clinical trials. By replacing traditional paper-based forms with interactive, electronic documents, eConsent ensures participants fully understand study protocols while enabling remote or on-site consent signing. Fully compliant with global regulatory standards, eConsent simplifies study enrollment, reduces administrative burden, and provides audit-ready documentation across all trial phases.
Solution Features
Interactive & Multimedia-Enabled Consent Forms
Improve participant comprehension with videos, images, and interactive FAQs. Reduce study dropouts by ensuring clear communication of trial requirements.
Electronic Signatures
Secure, legally binding digital signing compliant with FDA 21 CFR Part 11, GDPR, and ICH-GCP. Enable remote or in-person signing with timestamped verification.
Real-Time Tracking & Version Control
Maintain up-to-date consent documents across multiple trial sites. Ensure compliance by automatically updating participants with new consent versions.
Remote & Site-Based Accessibility
Allow participants to review and sign consent forms from home or at the trial site. Reduce site workload by eliminating the need for physical document storage.
Audit-Ready Documentation
Maintain detailed, time-stamped records for regulatory inspections. Ensure transparency and security with automated audit trails.
Benefits
Improved Participant Experience
Easy-to-understand digital consent enhances comprehension.
Faster Enrollment
Digital workflows accelerate the consent process and reduce delays.
Regulatory Compliance
Fully meets global standards, ensuring legally valid consent.
Seamless Integration
Works with CTMS, eSource, and EDC platforms for streamlined workflows.
Reduced Site Burden
Minimize paperwork and administrative workload with automated tracking.
Better Data Security
Encrypted storage ensures participant consent is safe and traceable.
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