We presented SafetyDrugs 6, the new native ICH R3 version of our pharmacovigilance database, to our customers. Here are the questions that arose.

The new rules ICH R3 ask pharmacovigilance databases for many changes and implementations. SafetyDrugs 6 in addition to comply, improves itself following the indications of our clients. The new version, that will be made official in November 2017, has been shown in preview to them. They asked us 3 curious questions that we share with you:

  1. “Since SafetyDrugs 6 has implemented the function for MedDRA codes updating, to comply with the new ICH R3 rules , what happens if the old code doesn’t match with the new one?”
    In this case a mask opens, in which the user sets the new corresponding code. After then the software will automatically combine the two codes for the future cases.
  2. “Is the Business Intelligence module integrable with external data?”
    Definitely yes! You can integrate data from various structured sources, such as other databases or Excel documents. We are, furthermore, studying an integration plan with the data contained in EVDAS (EudraVigilance Data Analysis System).
  3. “With the new release of SafetyDrugs, which Java version is required?”
    No Java Virtual Machine has to be installed on the user’s PC, since it is embedded in Oracle 12, the database on which SafetyDrugs 6 is developed.

Do you have other questions? Contact us, we are glad to answer you!