Important Risk Visualizer® for RMP
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).
Provides a comprehensive safety summary about signals and aggregation for safety specifications based on an RMP
Displays signals detected by four different analytical methods
Enables you to compare your company’s drugs and others with the same indications
Provides stratified data based on aggregation criteria
Displays the number of adverse events (AEs) in time series
Enables you to compare your company’s drugs with other similar drugs
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.
Please contact us via our inquiry form if you want more details on the product and related services.
Our IRV personnel will discuss your requirements with you.
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)
|Japanese safety database||JADER (JADER is the PMDA database.)|
|International safety database||FAERS (FAERS is the FDA database.)|
|Local Database||In-house safety DB|
*1 Subject to change due to currency fluctuation
Information provided above is true as of January 2017.
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.
- 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
- What is the IRV?
The IRV enables you to visualize important risks through automatic alerts and effectively supports RMP-based safety measures.
- What kinds of data sources can the IRV work with?
IRV Standard Edition – “Japanese Adverse Drug Event Report Database” or JADER, the Pharmaceutical and Medical Devices Agency (PMDA) database for information on adverse effects, in-house safety databases are available.
IRV Global Edition – “FDA Adverse Event Reporting System” or FAERS, the FDA database for information on adverse effects, in addition to JADER and in-house safety databases are available.
- What kinds of departments use the IRV?
The IRV is a useful tool for departments in charge of drug safety (pharmacovigilance), regulatory affairs and medical affairs.
- What functions does the IRV provide?
The IRV provides functions such as alerts, summaries, signals, trends, aggregation, tasks, comparisons, and spreadsheet output.
- What statistical methods are used for signal detection?
Four statistical methods are used for signal detection: ROR, PRR, BCPNN, and GPS. The same as those are used by regulatory authorities.