Argus Safety maintenance & upgrades
Day-to-day administration, patching, version upgrades, and performance tuning for Oracle Argus Safety — on-premise or hosted.
Legacy systems → standardized reporting
Three data streams. One source of truth.
Trilogy Data Partners helps organizations turn tangled legacy systems into a single, standardized reporting solution — with deep roots in pharmacovigilance and drug safety, from Oracle Argus Safety and cloud migrations to custom interfaces, dictionary management, and CFR Part 11 validation.
Case intake · live
Processing
99.98%
Reporting uptime
E2B R3
Submissions
0
Missed timelines
Trusted by four of the world’s five largest pharmaceutical companies.
Top-5 global pharma
CRO safety teams
Emerging biotech
4M+
ICSRs processed on platforms we maintain
15+
Argus Safety upgrade & cloud programs delivered
40+
MedDRA & WHODrug dictionary cycles managed
100%
Validation deliverables audit-ready
What we do
View all offerings
Everything your safety database needs to stay compliant and running.
Cloud migration & managed services
Move Argus and adjacent safety systems to OCI, AWS, or Azure with validated lift-and-shift, then hand the running of it to us.
Custom interfaces & integrations
Purpose-built interfaces between safety databases and clinical, regulatory, quality, and literature systems — no more manual re-keying.
MedDRA & WHODrug dictionary updates
Scheduled dictionary version upgrades, recoding impact analysis, and browser configuration — executed with zero surprise findings.
CFR Part 11 & GxP compliance
Audit trails, e-signatures, access control, and data-integrity controls mapped to 21 CFR Part 11 and EU Annex 11 — ready for inspection.
Reporting & analytics integration
Consolidate case data into governed reporting layers and dashboards, so submissions, aggregate reports, and signals draw from one source of truth.
Validation, done right
Validation process improvements that speed up releases instead of slowing them down.
We modernize computer system validation for safety platforms — risk-based, right-sized, and largely automated — so you stay inspection-ready without freezing your roadmap.
- Risk-based CSV & CSA. Test effort focused on patient-safety and data-integrity risk, aligned to GAMP 5 second edition.
- Automated test execution. Reusable, scripted regression suites that cut upgrade validation cycles by weeks.
- Traceable by design. Requirements-to-test traceability that survives audits and version changes.
Requirements traced482 / 482
Test cases executed1,196
Deviations open0
21 CFR Part 11 controlsVerified
Validation summaryApproved
Solutions
We start with the outcome you’re accountable for.
Whether it’s an on-time submission, a clean inspection, or a platform that finally talks to your other systems — we work back from there.
Keep the lights on
Managed safety operations, dictionary cycles, and upgrades handled by specialists so your team focuses on cases and signals.
Modernize the platform
Cloud migration, integrations, and reporting that remove manual work and give leadership real visibility.
Pass every inspection
Right-sized validation and Part 11 controls that hold up under FDA, EMA, and MHRA scrutiny.
See the whole picture
Integrated data flows and dashboards that turn scattered case data into governed, decision-ready reporting.
Who we serve
Built for the scale and scrutiny of global pharma.
“They treat our safety database the way we do — like patient lives depend on it being right. Upgrades that used to cost us weeks of downtime now happen quietly, on schedule.”— Global Head of Pharmacovigilance Systems, top-5 pharmaceutical company
Let’s make your safety systems boring — in the best way.
Reliable, compliant, and quietly doing their job. Tell us what’s keeping your PV systems team up at night, and we’ll bring a plan.
Book a consultation