Electronic Data Capture
QuantClinica EDC is a modern, AI-enhanced system for collecting, validating, and managing clinical trial data. From eCRF design to database lock, every step is designed for speed, accuracy, and regulatory compliance.
Electronic Data Capture (EDC) is a validated, web-based software system used in clinical trials to collect clinical data electronically from study subjects. Instead of relying on handwritten paper Case Report Forms (CRFs), data is entered directly into electronic CRFs (eCRFs) through a secure, centralized platform.
EDC has become the global standard in clinical research because it eliminates transcription errors, enables real-time data validation, supports remote monitoring, and ensures audit-ready compliance with 21 CFR Part 11, ICH GCP, HIPAA, and GDPR.
Drag-and-drop eCRF builder with advanced validation, CDASH compliance, and reusable form libraries. Build studies faster without compromising quality.
Real-time edit checks, range validations, and automated discrepancy management ensure high-quality data from the point of entry.
Automated query generation, resolution tracking, and real-time dashboards help resolve discrepancies faster.
Immutable, time-stamped logs of all data entries, changes, deletions, and user actions — fully 21 CFR Part 11 compliant.
Compliant e-Signatures linked to user identity with MFA support, meeting FDA requirements for electronic records.
Real-time dashboards for recruitment, data progress, query status, and site performance. Export-ready for stakeholders.
QuantClinica EDC is engineered to meet the most stringent global regulatory requirements, ensuring your trials are always audit-ready.
EDC is a digital system that replaces paper CRFs with electronic forms (eCRFs) for collecting, validating, and managing clinical trial data in real time.
Through real-time validation, edit checks, audit trails, role-based access, electronic signatures, and ALCOA+ compliance principles.
Paper CRFs are slow, error-prone, and difficult to monitor remotely. EDC enables real-time data entry, automated queries, remote monitoring, and instant data access.
Yes. QuantClinica EDC is fully compliant with FDA 21 CFR Part 11 regulations for electronic records and electronic signatures.
Yes. QuantClinica EDC supports multi-language, multi-site, multi-country clinical trials with role-based access for global teams.