Key offerings for pharmacovigilance and drug-safety systems.
A focused set of services covering the full life of a safety platform — from the database itself to the dictionaries, integrations, compliance evidence, and reporting around it.
Argus Safety maintenance & upgrades
End-to-end administration of Oracle Argus Safety — configuration, patching, performance tuning, and major version upgrades — delivered inside your maintenance windows with full rollback plans.
Cloud migration & managed services
Validated migration of Argus and adjacent safety systems to OCI, AWS, or Azure — including sizing, cutover, disaster recovery, and ongoing managed operations once you’re live.
Custom interfaces & database integration
Purpose-built integrations connecting safety databases with clinical, regulatory, quality, literature, and call-center systems — E2B (R2/R3) gateways, APIs, and ETL that end manual re-keying.
MedDRA & WHODrug dictionary updates
Scheduled dictionary version upgrades with full recoding impact analysis, browser and auto-encoding configuration, and documentation — so every case is coded to the current terminology without disruption.
CFR Part 11 & GxP compliance
Design and remediation of audit trails, electronic signatures, access controls, and data-integrity safeguards mapped to 21 CFR Part 11, EU Annex 11, and ALCOA+ — with the evidence to prove it.
Validation process improvement
Risk-based computer system validation aligned to GAMP 5 (2nd edition) and CSA, with automated regression testing and requirements-to-test traceability that shortens upgrade cycles.
Reporting, analytics & signal enablement
Governed reporting layers, aggregate report automation, and dashboards built on consolidated case data — giving safety leadership and signal teams a single, trustworthy view.
Not sure which offering fits your situation?
Tell us the outcome you’re after and we’ll map it to the right combination of services — or tell you honestly if we’re not the right partner.
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