Open Source EDC Platform
LibreClinica — EDC & Clinical Data Management
Open-source Electronic Data Capture (EDC) and Clinical Data Management (CDM) system. Collects, manages, and audits clinical trial data electronically.
标准：
21 CFR Part 11
GCP
CDISC ODM/SDTM
HIPAA
GDPR/KVKK
核心功能
eCRF Design & Build
Drag-and-drop study design, eCRF creation, edit checks, and rule definition.
Multi-Site Data Capture
Real-time data collection via web-based entry in multi-center studies.
CDISC Standards Compliance
Full compliance with CDISC ODM, SDTM, and other standards. Data export and integration support.
Audit Trails & eSignatures
21 CFR Part 11 compliant audit trails, electronic signatures, and role-based access control.
Monitor & Manage
Data monitoring, query management, discrepancy resolution, and data quality assurance.
REST API Integration
Integration with IWRS, other systems, and third-party tools via open architecture.