Compliance & Validation — Documented
GxP validated, 21 CFR Part 11, HIPAA, GDPR, SOC 2 Type II, ISO 27001
ArisGlobal
Life sciences platform automating pharmacovigilance, regulatory, and medical affairs with AI.
ArisGlobal's LifeSphere platform provides cloud software for drug safety and pharmacovigilance, regulatory affairs, clinical, and medical affairs. It applies automation and AI to case intake and processing, signal management, aggregate safety reporting, and regulatory information management for pharmaceutical companies and CROs. In July 2026 Dassault Systèmes announced a definitive agreement to acquire ArisGlobal, with closing expected in the second half of 2026 subject to regulatory approvals; the transaction had not closed as of late July 2026.
- Headquarters
- Miami, United States
- Founded
- 1987
- Compliance
- GxP, 21 CFR Part 11, HIPAA, GDPR, SOC 2 Type II, ISO 27001
- Deployment options
- cloud, private-cloud
- Website
- https://www.arisglobal.com
- https://www.linkedin.com/company/aris-global
Categories
AI Use Cases
- Case Processing Automation
- Label Intelligence & Maintenance
- Regulatory Submission Authoring
- Signal Detection & Aggregate Reporting
Vendor Scorecard
93% — Complete coverage. Coverage score — how completely Atlas documents ArisGlobal across 7 buyer-evaluation areas. Reflects available Atlas data, not solution quality.
Deployment & Hosting — Documented
cloud, private cloud
Pricing Transparency — Documented
Enterprise license by module
Implementation & Onboarding — Documented
6–12 months
Organization & Role Fit — Documented
Mid-Size Biotech, Large Pharma, Top 20 Pharma, CRO / CDMO, Pharmacovigilance, Regulatory Affairs, IT / Digital, Data Management
Solution Scope — Documented
Adverse Event Detection, Natural Language Processing, Regulatory Submission Authoring
Company Viability — Partially documented
Private, Founded 1987
Always ask the vendor
Not captured in Atlas data — confirm directly. Excluded from the score above.
Data Rights & IP
Who owns model outputs? Is our proprietary data used to train models others can access, and where does our data reside?
Model Credibility & Explainability
Can you share validation studies or benchmarks, explain how the model reaches its conclusions, and describe how bias and drift are monitored?
Evidence & Outcomes
U.S. FDA went live with FAERS II adverse-event reporting powered by LifeSphere MultiVigilance
ArisGlobal announced the go-live of the U.S. FDA's Adverse Event Reporting System (FAERS II), an electronic safety-reporting platform powered by its LifeSphere MultiVigilance software — the federal drug-safety regulator running adverse-event intake on ArisGlobal technology as part of the FDA's technology modernization efforts.
press release (ArisGlobal (PR Newswire)) · 2021-12-15 — Partner: U.S. FDA
Questions to Ask This Vendor
- How much of ICSR case processing can be automated end-to-end?
- How does LifeSphere handle global regulatory reporting obligations?
- What validation documentation is provided for GxP environments?