eConsent

Castor's eConsent software is a modern, all-in-one electronic informed consent platform designed for clinical trials of any size and design — whether traditional, hybrid, or fully decentralized. Built to support both on-site and remote study participants, Castor eConsent streamlines the entire patient journey from recruitment and screening through to enrollment and data capture, reducing site burden and improving the participant experience throughout.

The platform's modular architecture means sponsors and research teams can adopt individual components as standalone solutions or combine them into a fully integrated ecosystem. Each element is designed to meet global regulatory requirements, including 21 CFR Part 11 compliance, making Castor eConsent suitable for clinical research organisations operating across multiple countries and regulatory environments.

Core eConsent Capabilities

• Built-in video calling for remote eConsent visits — no third-party plugin or download required, with secure, encrypted video communication
• Integrated eSignature functionality, enabling patients to sign consent forms remotely or on-site within the same platform
• Informed Consent Form (ICF) management with versioning, ensuring sites always use the correct form version; new ICFs can be created quickly by duplicating existing ones
• Patient re-consent workflows for amended protocols
• Multiple consent forms supported across single or multiple sites
• Full audit trail and multi-factor authentication for tamper-proof eConsent and ease of use

Patient Recruitment and Enrollment

• Customisable patient eRecruitment portal landing page allowing study subjects to enrol organically
• Study managers can manually send patients invitations to enrol in a clinical trial
• Integrated pre-screening questionnaires to filter for qualified applicants before consent is captured
• End-to-end patient onboarding workflow, from initial sign-up through to full enrolment
• Increases patient access and diversity by enabling remote enrollment from participants' homes

Real-Time Enrollment Tracking and Oversight

• Study coordinators can monitor in real-time where each patient is within the enrollment process
• ICF and participant reporting with status overview for full visibility of the consent funnel
• Ability to assist patients at any stage while maintaining compliance with regulatory requirements

Platform Integration and User Management

• Native integration with the Castor product suite, including EDC and ePRO app, enabling uninterrupted data capture flow within a single ecosystem
• Patient data from enrolled participants can automatically be updated in Castor EDC upon consent capture
• Open architecture with RESTful API for flexibility to integrate with other eClinical technology vendors
• Single login experience covering eConsent, ePRO, eCOA, EDC, and device/wearables data
• Flexible user roles supporting the full consent workflow and multicenter study responsibilities, including Patients, Caregivers/Guardians, Study Admin, Site Admin, Investigator, Monitor, and Read-only users

Compliance and Security

• 21 CFR Part 11 electronic signature compliant
• Industry-leading encryption to protect patient privacy and ensure tamper-proof eConsent
• Full audit trail maintained throughout the consent process
• Multi-factor authentication for secure access
• Global regulatory compliance to support international clinical research

Deployment Packages

1. Remote Consent Essentials: Consent patients on-site or remotely with built-in video calling and eSignature, ICF and participant reporting, and global regulatory compliance — reducing site burden while improving patient retention and study comprehension.
2. Recruitment and Enrollment: All remote consent features plus a customisable eRecruitment portal and integrated pre-screening questionnaire, enabling an end-to-end patient onboarding workflow and accelerating recruitment.
3. One System, One Trial: The full suite combining eConsent, recruitment and screening, and EDC in a single platform — reducing clinical trial complexity, implementation costs, training requirements, and deployment overhead through one login and one solution.

Castor eConsent is trusted by leading life sciences organisations and has demonstrated real-world impact, including supporting the enrollment of over 17,824 patients in 15 weeks during a global pandemic for a decentralised COVID-19 study backed by Takeda and Julius Clinical. The platform is designed to reduce clinical trial costs and complexity while accelerating enrollment and increasing participant retention across studies of any scale.