eConsent

Octalsoft eConsent is an electronic informed consent platform designed for sponsors, CROs, and clinical trial sites. It digitizes the full consent process — from form creation and patient education through to signing, storage, and audit reporting — while incorporating AI-driven compliance checks and real-time oversight. The platform is built to support global clinical research, with compliance aligned to FDA 21 CFR Part 11, ICH-GCP, and GDPR.

The software is intended for use across the clinical trial ecosystem, serving sponsors seeking centralized oversight, CROs managing consent across multiple studies, site staff handling patient interactions, and patients requiring accessible, multilingual consent materials.

AI-Enhanced Patient Understanding

• Consent forms support multimedia content including video, audio, and graphics to improve patient comprehension.
• Adaptive learning quizzes verify that patients understand the information presented before proceeding.
• Multiple languages and accessibility options are supported to accommodate global patient populations.

Streamlined Digital Workflows

• Digitizes the complete consent documentation process, covering form creation, patient signing, and document storage.
• AI detects incomplete forms or missing approvals before they cause delays.
• Real-time updates sync across all participating sites and stakeholders.
• Reduces paper-based errors and associated trial delays.

Secure Identity Verification

• Supports e-signatures with advanced identity authentication methods.
• AI-powered fraud detection is applied to strengthen the integrity of the consent process.
• Compliance with FDA 21 CFR Part 11, ICH-GCP, and GDPR is built into the platform.

Version Control and Audit Readiness

• Automatic version tracking is maintained across sites and protocols.
• AI prevents outdated consent form versions from being circulated to patients or staff.
• Audit-ready logs provide full traceability of consent activities.
• Simplifies the process of regulatory inspections by centralizing consent records.

Real-Time Oversight and Analytics

• A centralized dashboard provides visibility across all trial sites.
• AI identifies predicted consent bottlenecks before they affect enrollment timelines.
• Generates compliance and enrollment metrics for use by sponsors and CROs.
• Supports faster trial startup through data-driven monitoring.

Integration and Interoperability

• Connects with CTMS, EDC, ePRO, IWRS, and rSDV systems within the Octalsoft eClinical Suite.
• AI maintains data consistency across integrated platforms to eliminate duplicate entries.
• Designed to function as part of a fully connected clinical trial ecosystem.

Role-Specific Benefits

• Sponsors: Accelerated study startup through streamlined consent workflows and centralized monitoring and reporting.
• CROs: Scalable consent management across multiple studies and protocols, with AI-driven analytics for risk prediction and performance tracking.
• Sites: Reduced administrative burden, simplified patient interactions, and tools to ensure every participant is properly informed.
• Patients: Access to clear, multilingual, multimedia consent forms designed for ease of understanding and confident decision-making.

Octalsoft eConsent is part of the broader Octalsoft eClinical Suite and is supported by 24/7 customer support, personalized onboarding, and ongoing optimization services. The platform is designed to meet global regulatory standards at every stage of the consent lifecycle.