Intelligent Consent
Management
Alethium simplifies site-based and remote consent processes for multinational trials across diverse budgets.
Our platform is built to accommodate complex consent scenarios, unlimited signers, multiple languages, and various document types — all while maintaining rigorous compliance with 21 CFR Part 11, Global National Commerce (ESIGN), and eDIAS regulations.
Effortless ICF Management
Alethium’s consent solution makes updating, uploading, and managing electronic and paper ICFs seamless, while maintaining a patient-centered approach that prioritizes comprehensive and coordinated care.
Compliant Consent
With multiple failsafes, consent deviations are all but eliminated from Alethium-supported trials. Our consent management system gives sponsors, investigators, and CRAs the control they need to manage complex consent and stay compliant.
Paper Consent
For many countries, paper consent with wet signatures is not only the desired format—it is required—leading to complex monitoring risks and logistics issues. Alethium’s Paper Consent delivers all of Alethium’s Intelligent Consent features including consent monitoring, reports, and remote consent management with 21 CFR Part 11 compliance.
eConsent
eConsent is the cornerstone of any decentralized trial, and Alethium’s eConsent system removes friction from every touch point to promptly consent participants and keep them consented for the duration of the trial. With Alethium managing the complexity of multiple consent versions and languages on a global scale, eConsent has never been easier.
Fully Compliant
Ensuring the highest standards for security, compliance, and privacy, Alethium provides 21 CFR Part 11 and GDPR-compliant digital signature capability with identity verification.
Robust Identity Verification
Alethium delivers a seamless participant journey and immediate, accurate ID confirmation with sophisticated digital identity verification across 195 countries.
Digital Signature
Electronic Signatures in Global and National Commerce (ESIGN) and eDIAS compliant, our eSign system meets the strict regulatory requirements for obtaining legally binding digital signatures.