U2XLab IT SYSTEM
U2XLab’s Integrated IT System: The New Standard in Clinical Trials
Real-Time Integrated Data Flow
- Analysis reception
- Method validation management
- Results Entry & Reporting
- eCRF Auto-completion
- Query generation and management
- Analysis result monitoring
- Lab Kit Order & Sample Pickup Request
- Sample Temperature & Location Tracking
- Real-Time Analysis Progress Inquiry
Core Values: 5 Key Values Delivered by Our Integrated Platform
True One-Stop Service
Upon the completion of our proprietary EDC solution, the entire workflow—[Sample Pickup – Sample Analysis – Data Entry – Quality Control]—will be seamlessly managed within a single platform, eliminating the need for separate third-party EDC vendors. We are committed to delivering an integrated solution that drastically reduces both time and operational costs for our sponsors.
Data Integrity & Real-Time Monitoring
A real-time DB integration system prevents data transmission errors, delays, and mistakes from manual entry. Real-Time TAT Prediction: By tracking timestamps for the entire process—from sample receipt to result approval—in real-time through our portal, we enhance the predictability of clinical operations.
Rigorous Quality Control & Complete Traceability
Our portal solution enables the tracking of the transport process and real-time temperature management, fundamentally preventing errors that may occur during the sample collection phase.
In the event of outlier data, our platform provides complete traceability, allowing users to instantly trace back the sample’s transport history, including metadata such as location and temperature.
Regulatory Alignment & Global Standards
Our upcoming proprietary EDC system is designed to comply with global regulations, including 21 CFR Part 11, ICH-GCP, and ICH E2B R3, providing a more robust audit trail and a highly reliable data management solution.
Accelerated Decision-Making with Differentiated Technology
Our platform offers the scalability to be flexibly applied across all clinical phases, from Phase I-III trials through to Post-Marketing Surveillance (PMS).
Moving forward, we will gradually roll out AI-based data analysis, automated statistical report generation, and automated query management features to actively support sponsors in making rapid decisions.
IT System Implementation Process
EDC Program Development
EDC Program IIT Application
& Usability Verification
EDC Program Qualification Acquisition
RVDS System Revamp Plan
Establishment of Sample Management Barcode System
Commercial EDC Launch
Completion of RVDS System Revamp
LIMS + EDC + RVDS integration
Through the integrated interface of LIMS, EDC, and RVDS, we have completed an IT solution that covers the entire analytical lifecycle—from sample collection and transport to test database management and EDC upload.