eConsent

The Electronic Consent (eConsent) Clinical Trial System streamlines the informed consent process, allowing participants to give consent both remotely and onsite. It supports a hybrid approach by capturing paper or electronic informed consent forms (ICFs) simultaneously.

This solution meets rigorous compliance standards, being EU-compatible and 21 CFR Part 11-compliant, in line with ALCOA++ standards.

To improve participant comprehension, the system incorporates educational enhancements such as images, video content, quizzes, and FAQs. Automating participant consent requests and site document assignments reduces the burden on trial sites, allowing for more efficient trial operation management.

Features

• Facilitates easy tracking and oversight with consent and IRB-approval statuses.
• Supports both electronic and paper-based consent processes.
• Enables remote, in-clinic, or hybrid workflow implementations.
• Allows for the collection of electronic signatures across multiple sites.

The flexible, web-based design prioritizes the patient experience as well as site needs, supporting seamless integration across various workflows and locations. Uploading paper consent forms, printing unsigned ones, and collecting eConsent across different regulatory environments can be managed with ease, ensuring a customizable process.

The system maximizes trial efficiency and operational excellence by improving data quality, engagement, and retention. It also reduces bias and optimizes study supply management.