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IRV: Signal Management Support

Whatʼs New

August 1, 2017 The IRV Global Version System, a signal management tool, was released.
August 1, 2017 Significant improvements to the calculation speed of the IRV achieved after moving to Hadoop.
August 1, 2017 The service is now available to produce signal results based on customer requests.
August 1, 2017 Product Information site goes live.

What is the IRV

The Important Risk Visualizer (IRV) is a “visualization tool” designed to provide your safety and medical affairs departments with a unified list of important risks for all required safety study parameters. By delivering a current overview of the status of all safety measures, it helps to ensure effective implementation of your risk management plan (RMP).


IRV Overview

Summary
Provides a comprehensive safety summary about signals and aggregation for safety specifications based on an RMP

Signal Detection
Displays signals detected by four different analytical methods
Enables you to compare your company’s drugs and others with the same indications

Aggregation
Provides stratified data based on aggregation criteria

Trends
Displays the number of adverse events (AEs) in time series
Enables you to compare your company’s drugs with other similar drugs

Important Risk Visualizer for RMP [PDF]

IRV Case Studies

IRV Case Studies – General

Here are some examples of how the IRV is used by the PV department of major pharmaceutical companies in Japan:

Case 1:Company A uses the IRV for signal management on a daily basis and for their periodic safety evaluation processes.

Case 2:Company B analyzes trends including class effect information using data from their safety database in a timely fashion with the IRV.

Case 3:Company C uses the analytical signal detection report function of the IRV as a part of their periodic safety evaluation process.

Research related signal management activities with the IRV

Company A:Research on impact analysis for signal management

Our company:Research for selecting appropriate SMQ and PT groups in signal management

The IRV setup process

After receiving an inquiry on the IRV from a customer, we take a step-by-step process all the way down to the introduction and implementation of the IRV and system support as described below.

Step1:Inquiry

Please contact us via our inquiry form if you want more details on the product and related services.

Step2:Consultation

Our IRV personnel will discuss your requirements with you.

Step3:Estimate

We will provide an estimate for an IRV implementation optimized for your needs.

  • Implementation fees
  • Validation support fees
  • Customization fees for an upload tool to import in-house safety database (DB)
  • Operational fees (See the below for the standard service fees)

 

Service fees

Global Edition

Japanese safety database JADER (JADER is the PMDA database.)
International safety database FAERS (FAERS is the FDA database.)
Local Database In-house safety DB
Monthly fee

EUR 16,500/month*1

USD 18,500/month*1

 

*1 Subject to change due to currency fluctuation

Information provided above is true as of January 2017.

Step4:Contract

Step5:Implementation

The chart below shows the standard process to implement the IRV. After starting a project, implementation using JADER and FAERS usually takes less than 3 months.

Note: Implementation using an in-house safety DB can take up to 6 months for data import preparation.

Step6:Operation

  • Cloud-based service (on ASP)
  • System support
  • Upon request, we can provide contract-based services such as signal calculation by proxy, master information update (e.g. selecting MedDRA version), import of JADER or shipment quantity

FAQ

What is the IRV?
What kinds of data sources can the IRV work with?
What kinds of departments use the IRV?
What functions does the IRV provide?
What statistical methods are used for signal detection?