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 pode ser encontrado em Patient Engagement Software categorias.