A list of FAQ

Question

Answer

QWhat is the IRV?

AThe IRV enables you to visualize important risks through automatic alerts and effectively supports RMP-based safety measures.

QWhat are some of the benefits of the IRV?

ASix key benefits of implementing the IRV

  • Prioritize targeted signals using visual alerts
  • Monitor AE trends in a time series
  • Check class effects to support the management of safety measures
  • Confirm signal position
  • Enable signal detection of PT groups
  • Export stratified data and case lists into Excel
QWhat kinds of data sources can the IRV work with?

A 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 adtition to JADER and in-house safety databases are available. 

QIs it possible to use WHO VigiBase?

A Yes. WHO VigiBase is scheduled to be available in the future.

QWhat is the maximum number of products that can be registered?

A 100 products.

QWhat kinds of departments use the IRV?

A The IRV is a useful tool for departments in charge of drug safety (pharmacovigilance), regulatory affairs and medical affairs.

QWhat is the maximum number of people who can use the IRV?

A The maximum number of users is 100.

QIs the system available in English?

A Yes. The IRV has an English user interface.

QWhat is the implementation cost?

A Cost varies according to the type of support services you require. We will present a cost estimate to match your requirements. Please contact us at inq@croit.com for further information.

QHow is the IRV service provided?

A The IRV is available as a cloud based SaaS.

QWhat functions does the IRV provide?

A The IRV provides functions such as alerts, summaries, signals, trends, aggregation, tasks, comparisons, and spreadsheet output.

QWhat statistical methods are used for signal detection?

A Four statistical methods are used for signal detection: ROR, PRR, BCPNN, and GPS. The same as those used by regulatory authorities.

QIs one product compared against only one product with same indications?

A Your company’s drug can be compared with not only one product but a drug group, a grouping of drugs with the same indications. For example, in the case of an anti-diabetic drug, it can be compared with a drug group of SGLT2 inhibitors.

QIs data such as aggregate AE stratified by age group available through the IRV?

A Yes. On the aggregation screen, up to six aggregation criteria such as gender, age, daily dosage, concomitant drug, or country where cases are reported for example can be displayed and the aggregated results can be exported to Excel. 

Note: The selectable aggregation criteria will vary depending on which database is in use.

QCan I view AE profiles in time series?

A Yes, you can. Furthermore, shipment quantity data as well as status of safety measures implementation can be displayed on a single chart and the interrelationship between the two can be checked.

QHow can the IRV signal detection results be exported?

A The IRV signal detection results can be exported to Excel.

QIs it possible to export AE line listings?

A Yes, these can be exported to Excel files.

QHow long does it take to implement the IRV?

A When you request to use JADER and FAERS, the system will become available for use, validation included, within about 3 months after the first kickoff meeting. Please refer to “The IRV setup process’’ for further information.

QIs support available for validation during the IRV implementation?

A Yes, it is available. We will provide you with support depending on your requirements.

QWhat types of training menus are designed for users?

A There are a variety of training options tailored to your needs various formats such as lectures and hands-on training based on actual use of the system.

QDoes the IRV have functionality to record the implementation status of safety measures?

A Yes, the IRV has a function to manage tasks and track its progress. The status of the safety measures implementation can be monitored and distributed among personnel concerned and their communications can be recorded and stored.


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