IRV (Important Risk Visualizer) · 2016. 3. 8. · Safety DB Japanese Adverse Drug Event Report...
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IRV offers extensive support for comprehensive PV monitoring and risk mitigation activities for RMP! 監視活動 for RMP Don’ t let important risk signals and trends unnoticed, And steadily execute RMP!
Transcript of IRV (Important Risk Visualizer) · 2016. 3. 8. · Safety DB Japanese Adverse Drug Event Report...
Safety DB
FAERS(FDA)
Safety DB
FAERS(FDA)
CAC EXICARE Customer(pharmaceutical company)
Servers
● Page viewing● Report printing● Task assignment confirmation, etc.
● Cumulative AE summary, trend graph compilation
● Line listing● List of Detected signals● Alerts● Product comparisons (AE trends, chronological cumulative case analysis, signals)
Internet
IRV Service Scope
Adverse Drug Event Reporting
Database (PMDA)
Delivery QuantitySales Data
PackageInsert
Adverse Drug Event Reporting
Database (PMDA)
RMP
Import
Master Data
for RMP
24-1 Nihonbashi Hakozakicho, Chuo-ku, Tokyo 103-0015, JapanPhone : +81-3-6667-8032 (Sales)E-mail：[email protected] http://www.exicare.com
● Copyright © 2014 CAC EXICARE Corporation. All right reserved.
Contact Information (Inquiries): CAC EXICARE Corporation
CAC EXICARE is to contribute to the creation of an affluent society is that people become healthy, IT & business partners to support the pharmaceutical.
IRV Service Overview & User Fees
IRV offers extensive support for comprehensive PV monitoring and risk mitigation activities for RMP!
監視活動
for RMP
● Provide IRV services as SaaS● Provide secure SaaS platform for IRV● Provide following services as contract basis:
● Help Desk● Enhance function to meet your specific requirements● Case data cleansing, master data creation, etc.● Various consultation services such risk analysis, CSV, etc.
● Standard Services (※) Implementation Cost: ￥3,000,000 Operational Cost: ￥1,000,000 / Month (Consumption Tax is NOT included)
※ Only for Safety DB (internal safety DB) and Adverse Drug Event Reporting Database (PMDA). Additional charge is required to support the FDA’s FAERS.※ The maximum number of users is 100, and the maximum number of product for monitoring is 20.
Service Overview
Service User Fees
Don’t let important risk signals and trends unnoticed,
And steadily execute RMP!
CAC EXICARE Corporation
Portal Page
Trend Comparison Page
Aggregated Cases (Time-Series) Page
Signal Comparison Page
Stratified Case Series Page (stratified by patients’ background)
Signal Page
Task Page
Summary Page
Trend Page
1 2
IRV Service Scope
Stratified Comparison with aggregated cases
Safety DB
Japanese Adverse Drug Event Report database (PMDA)
FAERS(FDA)
Competitive Products Comparison
Grasp Class Effect
Competitive Products Comparison
Grasp Class Effect
Aggregated AE Cases Signal Detection Aggregated AE Cases Signal Detection
Stratified Comparison with aggregated cases
Safety Measure TasksCommunication
Safety Measure TasksCommunication
Display the number of serious conditions or the signals.
IRV (Important Risk Visualizer) provides a safety department with a visualization tool for Signal Detection, Trend Analysis and Competitor Analysis for each required safety specification of
RMP.IRV enables effective PV activities based on RMP for PV professionals.
Product Overview & Use Case
Main Pages and Transition Pages (flows)
AE trends, number of case series, and signals.
IRV, a tool for Trend Analysis and Visualization of Important Risks
Summary Trend Signals
● Provides a comprehensive view on signals and number of AE cases in each product Safety Specification (SS). Detects newly captured AEs and signals based on the customized criteria.
Displays the relation between the number of AEs and the delivered quantity.
Stratified condition is customizable (e.g. by age, gender, indication, primary disease, etc.)
for RMP
Five Key Benefits
※ Safety DB : Internal drug Safety Database※ PMDA ： Pharmaceuticals and Medical Devices Agency Database (Japan’s adverse drug event reporting database)※ FAERS ： FDA Adverse Event Reporting System (The FDA’s adverse drug event reporting database)
Enables comprehensive PV monitoring and safety measures for the important risks in RMP.
1． Detects signals (ROR,PRR,BCPNN,GPS) with alerts.2． Provides trend comparisons with competitive products (class effect).3． Provides stratified comparisons with aggregated cases and AE time series trends.4． Enables managers and staff communication regarding the status of safety measures.5． Avoid cost increasing for safety measures.
Signal Detection methods are the same as used by health care authorities (ROR, PRR, BCPNN, GPS).
Alerts
Product Comparisons
Portal Page
Trend Comparison Page
Aggregated Cases (Time-Series) Page
Signal Comparison Page
Stratified Case Series Page (stratified by patients’ background)
Signal Page
Task Page
Summary Page
Trend Page
1 2
IRV Service Scope
Stratified Comparison with aggregated cases
Safety DB
Japanese Adverse Drug Event Report database (PMDA)
FAERS(FDA)
Competitive Products Comparison
Grasp Class Effect
Competitive Products Comparison
Grasp Class Effect
Aggregated AE Cases Signal Detection Aggregated AE Cases Signal Detection
Stratified Comparison with aggregated cases
Safety Measure TasksCommunication
Safety Measure TasksCommunication
Display the number of serious conditions or the signals.
IRV (Important Risk Visualizer) provides a safety department with a visualization tool for Signal Detection, Trend Analysis and Competitor Analysis for each required safety specification of
RMP.IRV enables effective PV activities based on RMP for PV professionals.
Product Overview & Use Case
Main Pages and Transition Pages (flows)
AE trends, number of case series, and signals.
IRV, a tool for Trend Analysis and Visualization of Important Risks
Summary Trend Signals
● Provides a comprehensive view on signals and number of AE cases in each product Safety Specification (SS). Detects newly captured AEs and signals based on the customized criteria.
Displays the relation between the number of AEs and the delivered quantity.
Stratified condition is customizable (e.g. by age, gender, indication, primary disease, etc.)
for RMP
Five Key Benefits
※ Safety DB : Internal drug Safety Database※ PMDA ： Pharmaceuticals and Medical Devices Agency Database (Japan’s adverse drug event reporting database)※ FAERS ： FDA Adverse Event Reporting System (The FDA’s adverse drug event reporting database)
Enables comprehensive PV monitoring and safety measures for the important risks in RMP.
1． Detects signals (ROR,PRR,BCPNN,GPS) with alerts.2． Provides trend comparisons with competitive products (class effect).3． Provides stratified comparisons with aggregated cases and AE time series trends.4． Enables managers and staff communication regarding the status of safety measures.5． Avoid cost increasing for safety measures.
Signal Detection methods are the same as used by health care authorities (ROR, PRR, BCPNN, GPS).
Alerts
Product Comparisons
Safety DB
FAERS(FDA)
Safety DB
FAERS(FDA)
CAC EXICARE Customer(pharmaceutical company)
Servers
● Page viewing● Report printing● Task assignment confirmation, etc.
● Cumulative AE summary, trend graph compilation
● Line listing● List of Detected signals● Alerts● Product comparisons (AE trends, chronological cumulative case analysis, signals)
Internet
IRV Service Scope
Adverse Drug Event Reporting
Database (PMDA)
Delivery QuantitySales Data
PackageInsert
Adverse Drug Event Reporting
Database (PMDA)
RMP
Import
Master Data
for RMP
24-1 Nihonbashi Hakozakicho, Chuo-ku, Tokyo 103-0015, JapanPhone : +81-3-6667-8032 (Sales)E-mail：[email protected] http://www.exicare.com
● Copyright © 2014 CAC EXICARE Corporation. All right reserved.
Contact Information (Inquiries): CAC EXICARE Corporation
CAC EXICARE is to contribute to the creation of an affluent society is that people become healthy, IT & business partners to support the pharmaceutical.
IRV Service Overview & User Fees
IRV offers extensive support for comprehensive PV monitoring and risk mitigation activities for RMP!
監視活動
for RMP
● Provide IRV services as SaaS● Provide secure SaaS platform for IRV● Provide following services as contract basis:
● Help Desk● Enhance function to meet your specific requirements● Case data cleansing, master data creation, etc.● Various consultation services such risk analysis, CSV, etc.
● Standard Services (※) Implementation Cost: ￥3,000,000 Operational Cost: ￥1,000,000 / Month (Consumption Tax is NOT included)
※ Only for Safety DB (internal safety DB) and Adverse Drug Event Reporting Database (PMDA). Additional charge is required to support the FDA’s FAERS.※ The maximum number of users is 100, and the maximum number of product for monitoring is 20.
Service Overview
Service User Fees
Don’t let important risk signals and trends unnoticed,
And steadily execute RMP!
CAC EXICARE Corporation
