Core EDC Features
A complete toolkit designed for modern clinical trials.
Dynamic eCRF Designer
Build complex electronic Case Report Forms (eCRFs) with our intuitive drag-and-drop builder and advanced validation rules.
Integrated Query Management
Automate and manage data queries in real-time. Resolve discrepancies faster and ensure cleaner data before database lock.
Role-Based Access Control
Granular permissions for Sponsors, CROs, Investigators, and Monitors, ensuring data is only seen and modified by authorized users.
Full Audit Trails
Immutable, time-stamped logs of all data entries, changes, and deletions, meeting strict 21 CFR Part 11 requirements.
Electronic Signatures
Securely sign off on eCRFs, queries, and study milestones with compliant e-Signatures linked to user identity.
Real-Time Analytics
Monitor recruitment, data entry progress, and query status with customizable dashboards for proactive trial management.
Built for Compliance, From the Ground Up
Our platform is engineered to meet and exceed the most rigorous global regulatory standards for clinical research.
- 21 CFR Part 11 Compliant
- GCP Compliant
- HIPAA Compliant
Contact Us
Email: admin@quantclinica.comPhone: 9910796164
Address: Dwarka, New Delhi
Disclaimer
QuantClinica EDC Platform is a comprehensive Electronic Data Capture system designed for clinical research and trial management. While we strive to maintain the highest standards of data integrity, security, and regulatory compliance, users acknowledge that:
- This platform is intended for authorized clinical research personnel and approved study participants only.
- All data entered must comply with applicable regulatory requirements including GCP, HIPAA, and 21 CFR Part 11.
- Users are responsible for ensuring data accuracy, completeness, and timely submission of clinical data.
- QuantClinica provides tools for data management but does not guarantee clinical outcomes or regulatory approval.
- System availability and performance may vary based on technical conditions and maintenance schedules.
- All study protocols and data collection procedures must be approved by appropriate regulatory bodies and ethics committees.
By using this platform, you agree to comply with all applicable clinical research regulations and institutional policies.