Keeping in mind the complex clinical data management needs, i2e developed a custom application to automate PK data scanning for abnormalities, visualizing detected issues, setting threshold parameters, and tracking user actions through audit logs. The solution also integrated a Secure File Transfer Process (SFTP) for Clinical Data Administration and Management (CDAM05).
Key features
- Automated abnormality scanning : Scans PK data automatically from a secure drive or manual upload, reducing manual effort and speeding up reviews.
- Subject-level insights in a dashboard view : Highlights abnormalities per subject, enabling quick issue identification and focused analysis.
- Privacy-first data handling : Displays only selected, non-sensitive abnormality data with visual summaries—never storing or exposing full datasets, ensuring sensitive clinical data remains protected.
- Audit logging and tracking : Every user action is tracked through audit logs, providing transparency and accountability for those who accessed or interacted with the data.
- Box plot visualization : Visualizes abnormalities across interventions using box plots for clear trend analysis and outlier detection.
- Threshold & user management : Allows administrators to adjust thresholds and manage user settings and privileges for secure and compliant operations.