serviceCzeekR (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.

Detail application image

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.
ex.1: Computing system
ex.2: Computing system

Business Flow Management System

Business flow management system tailored to customer's SOP

Business flow image

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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 events (adverse effects) that have been registered, analyzed, and reviewed are automatically tracked.
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

Signal calculation function / Visualization of various statistical analysis

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)

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