CzeekR (Signal Detection Support System)
* Kyoto Constella Technologies will continue to provide it’s services as INTAGE Healthcare.
An application that enables business flow management and signal detection
CzeekR is equipped with both RMP management system [business flow management] and signal calculation tool [data mining support].
The signal detection function presents scores based on search conditions, such as database and drugs, set by the user. Functions such as signal detection and event search can be utilized for statistical analysis support. The linkage function with the RMP management system, can be used to store signal detection information as a management log. Furthermore, the tracking function can be utilized to enable time-series analysis and continuous monitoring.
Service Overview
- Business task flow management system that supports risk management planning (RMP)
Makes possible the design of RMP based on customer SOP and cloud-based management. - Equipped with signal calculation system
The data set for score calculation can be set by the user, and the detected signal can be linked with RMP, enabling the management of the process log as a tracking function. - Equipped with FDA accumulated adverse event report data (FAERS) and also allows utilization of data prepared by the user(*)
Approximately 13 million reports (1997-present) are organized and included in the system.
Search and display in Japanese is enabled, and data is updated once every quarter.
* Please contact us for details about using in-house/PMDA (JADER) data or others. - The Visualizer enables visual inspection of statistical data
Statistical analysis information such as time series display, histogram, heat map, distribution map, Dots model analysis, etc. is incorporated as a data mining support tool.
Business Flow Management System
Business flow management system tailored to customer's SOP
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* The number of steps, the setting of the steps required for approval, and the contents of the report can be designed according to the customer's SOP.
Tracking function
The necessary information and items from the contents reported in the above steps are extracted and saved as a list.
Sample output
| Event | Product name | Project name | In-charge of task | Supervisor | Date | Current state | End of study | Status |
|---|---|---|---|---|---|---|---|---|
| stroke | AAA | AAA | Yamada | Hayashi | Sept. 1 | On-going study | Oct. 1 | STEP4 |
Signal Calculation System
Following the selection of the target DB, the data set will be created after setting extraction conditions in items such as medicine / indication / adverse effects. Based on the data set, calculation of score (*1) as a signal that indicates drug-adverse effect/indication relationship will be started.
Enables selection of DB, and setting of all search conditions
*1 The system is equipped with statistical analysis methods (signal: see table below) used by major worldwide regulatory agencies, and the results are displayed after automatic calculation.
| Signal | Regulatory agency |
|---|---|
| PRR | EMA（European Medicines Agency） |
| ROR | Lareb（Netherlands Pharmacovigilance） |
| IC | WHO（World Health Organization） |
| EBGM | FDA（Food and Drug Administration） |
For further information onINTAGE Healthcare Inc.
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