eConsent

eConsent is a digital solution designed to enhance transparency, compliance, and participant engagement in clinical trials by streamlining and securing the informed consent process. It replaces traditional paper-based forms with interactive, electronic documents, ensuring participants fully understand study protocols while allowing for remote or on-site consent signing. This solution is fully compliant with global regulatory standards, simplifying study enrollment, reducing administrative burdens, and providing audit-ready documentation across all trial phases.

Solution Features

• Interactive & Multimedia-Enabled Consent Forms: Enhance participant comprehension with videos, images, and interactive FAQs, reducing study dropouts by ensuring clear communication of trial requirements.
• Electronic Signatures: Provides secure, legally binding digital signing compliant with FDA 21 CFR Part 11, GDPR, and ICH-GCP, enabling remote or in-person signing with timestamped verification.
• Real-Time Tracking & Version Control: Maintain up-to-date consent documents across multiple trial sites and 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, reducing site workload by eliminating the need for physical document storage.
• Audit-Ready Documentation: Maintain detailed, time-stamped records for regulatory inspections, ensuring 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.