serviceSystem Services (CzeekV Pro/CzeekR)

Contains adverse event report data worldwide

• Installed both FAERS and JADER databases
• Enables search and display in Japanese by data arrangement including elimination of duplicates

*FAERS (FDA’s Adverse Event Reporting System): a public database administrated by the FDA containing adverse event reports, medication error reports and product quality complaints resulting
*JADER (Japanese Adverse Drug Event Report database): a public database administrated by the PMDA containing adverse event reports.

Exploration of relationship between "drugs and adverse events" and statistical analysis

• Signal detection index values are calculated by four statistical methods adopted by major regulatory authorities throughout the world
• Detailed statistical analysis by country, age, gender, etc.

Function 1: Display search/statistical analysis/various graphs

Various search functions and case reports can be displayed.

• Score reports based on search criteria (number of events, score index value)
• Number of days to the onset of event, histogram of the number of reports in each period, etc.
• List of case reports and individual case reports

|image scroll

Function 2: Signal detection at the time of database update

Newly detected signal information is extracted and displayed in a table at the time of database update.
You can also sort items and search by drug or adverse event.

Target databases: FAERS (quarterly), JADER (monthly)

|image scroll

Function 3: Retain the history of search criteria

As the past search criteria are retained as history, it is easy to search with the same criteria.

|image scroll

Installed Databases

• Installed both FAERS and JADER databases
• Enables search and display in Japanese by regular data arrangement including elimination of duplicates at the time of data update.
• Your own database can be installed.

*FAERS (FDA’s Adverse Event Reporting System): a public database administrated by the FDA containing adverse event reports, medication error reports and product quality complaints resulting
*JADER (Japanese Adverse Drug Event Report database): a public database administrated by the PMDA containing adverse event reports.

Signal Calculation System

With a computational function, score values can be derived according to your own data setting.

• Customers can design their own search criteria settings such as database and drugs to calculate score value as a signal detection index by batch processing.
• You can add duplicates elimination criteria and conditions other than country, age and gender.
• Scores are calculated by four statistical methods (PRR, ROR, BCPNN and GPS) adopted by major regulatory authorities throughout the world

Function 1: Search criteria setting and calculation of signal index values under your own criteria

• Set various conditions from the list of search criteria and calculate the signal detection index value

|image scroll

Function 2: Display various graphs and maps

• Statistical analysis data including signal index values can be checked visually

(- display in chronological order, histogram, heat map, distribution map, etc.)

|image scroll