OpenEDC

This modern, secure platform enables end-to-end electronic data capture for clinical research, including electronic consent, patient-reported outcomes, eSource data, and decentralized trials, with multilingual form creation, real-time validations, branching logic, repeatable elements, audit trails, role-based access, and cryptographic electronic signatures to ensure data integrity across multi-center studies. It addresses regulatory compliance and data protection challenges for pharmaceutical, biotechnology, medical device, CROs, hospitals, and research institutes by meeting ICH-GCP, FDA 21 CFR Part 11, EU Annex 11, GDPR, and MDR requirements, offering features such as data pseudonymization, two-factor authentication, data import/export, query management, source data verification, reports and insights, calendar management, patient engagement via apps and reminders, and full modularity for customization and scalability.

OpenEDC може да се намери в Patient Engagement Software категории.