Pharmacovigilance Electronic Safety Database Services
Implementation and maintenance-
iSafety implementation services for Oracle ARGUS Safety Database are strategically tailored to support customers necessities in meeting their regulatory obligations for their pharmacovigilance ICSR (Individual case safety reports) process.
We offer solutions in implementation of Oracle Argus Safety database with its latest updated version.
Hosting and Integrations
Hosting ARGUS database for a vendor include various cross functional training given by in-house experts for end user, IT and Administration.
iSafety operations and database are protected by multiple layers of defenses in our fully validated data centre with redundant power supply, and a 24/7 application support.
ARGUS XPDite integrates end-to-end safety and risk management into one comprehensive platform this makes it feasible to pull out relevant safety data for aggregate and signal reports.
Safety Data Migrations
Safety Data Migration is a complex process as majority of the organizations are transitioning to an advanced and updated electronic database which is compliant to E2B-R3 from their old safety database.
iSafety offers experts, who have extensive knowledge and experience in migrating legacy safety data on different electronic safety database systems well within required desired timelines. Our Data Migration Strategy is operative for the following models
- Safety database like ArisG, ARGUS, Empirica Trace, AERS (version to version)
- ARISg to ARGUS and vice versa
- Manual Safety Data to electronic
- Data Testing and Validation
- Quality and Compliance Check