eConsent

Prelude eConsent is a digital informed consent platform designed for clinical trials. It replaces paper-based consent forms with interactive, web-accessible tools that allow participants to review and sign consent documents either onsite or remotely from their own devices. The platform is intended for research sponsors, clinical operations teams, and study sites seeking to reduce administrative burden, improve participant understanding, and maintain regulatory compliance throughout the consent process.

The software is accessible via web browser on clinic or personal devices, supports all trial phases, and is designed to scale across single or multiple studies with varying consent methods and regulatory requirements.

Core Capabilities

• Guided digital consent that walks participants through the process with clear steps, embedded media, and simple sign-off workflows
• Remote and onsite access, allowing participants to review and sign from any web browser or mobile app without requiring clinic visits or special devices
• Multimedia content support, including videos, diagrams, and interactive question-and-answer tools to improve participant understanding and reduce misunderstandings
• Built-in field validation that ensures all required fields are completed and signatures are properly captured, reducing errors associated with paper forms
• Version control and full audit trails that log every signature, timestamp, and document update with clear attribution
• Centralized tracking for site and sponsor teams to manage consent status, support re-consent during protocol amendments, and monitor compliance

Compliance and Security

• Compliant with HIPAA, 21 CFR Part 11, and GDPR requirements for electronic records and signatures in clinical trials
• Validated compliance with FDA, EMA, and IRB standards to support regulatory submissions and audit readiness
• Automatic logging of all actions, including who completed each step and when, to support documentation for IRBs and regulators
• Secure platform for collecting consent both before study start and during protocol amendments

Benefits for Sites, Sponsors, and Participants

• Reduces participant dropout and noncompliance by improving understanding through interactive and visual consent materials
• Supports decentralized, hybrid, and hard-to-reach trial populations through remote consent access
• Decreases administrative burden on site staff by eliminating incomplete or illegible paper forms
• Speeds up study startup and re-consent processes through centralized tracking and fewer delays
• Provides a consistent experience for both sponsor employees and site personnel, with an interface noted by users as intuitive and easy to use

Scalability and Study Support

• Designed to support all clinical trial phases and a variety of consent methods
• Accommodates multiple studies simultaneously with consistent compliance tracking across each
• Includes responsive project management and customer support teams as part of the service offering

Prelude eConsent is part of a broader suite of clinical trial software that includes EDC, ePRO, and RTSM capabilities. The platform serves therapeutic areas including oncology, CNS, rare disease, and infectious disease, and is used across industries including biotech, pharmaceuticals, medical devices, and academia.