Company
Novartis AG (Top 5 Global Pharmaceutical)
Scope
Enterprise-Wide Pharmacovigilance
Portfolio
300+ marketed products across 15 therapeutic areas
Challenge
PSUR deadline compliance and preparation efficiency
ArcaScience Modules Used
Data Intelligence, Automated Outputs, Decision Intelligence
Timeline
24-week enterprise implementation
The Challenge
Enterprise-Scale PSUR Compliance Across a Massive Portfolio
Novartis faced systemic challenges managing PSURs for 300+ products. 22% of PSURs were submitted with deadline pressure in the final 48 hours. Manual preparation required 16–20 weeks per complex PSUR. Cross-functional coordination across 8 global safety hubs was inconsistent. The EMA's stricter timelines and format requirements increased compliance risk. Annual PV operations cost exceeded $85M with significant FTE allocation to document preparation rather than scientific analysis.
The Solution
ArcaScience Enterprise PSUR Automation Platform
ArcaScience implemented an enterprise-wide PSUR automation platform, creating standardized workflows and AI-driven document generation across Novartis's entire product portfolio.
Implementation Process
Weeks 1–4
Enterprise Assessment
Audited existing PSUR workflows across all therapeutic areas. Mapped data sources and system integrations (Argus, AERS, clinical databases). Defined standardized templates and quality criteria.
Weeks 5–10
Platform Configuration
Connected to Novartis's global safety databases. Configured AI models for each therapeutic area's signal detection needs. Built automated data extraction and aggregation pipelines.
Weeks 11–16
Pilot Deployment
Rolled out to first 50 products across 3 therapeutic areas. Validated output quality against historical PSURs. Refined AI models based on reviewer feedback.
Weeks 17–20
Enterprise Rollout
Extended to remaining 250+ products. Trained 120+ PV professionals across 8 global hubs. Integrated with existing regulatory submission systems.
Weeks 21–24
Optimization & Handover
Fine-tuned automation based on first full cycle results. Established ongoing monitoring and model update processes. Transferred operational ownership to Novartis PV team.
Results
60%
Reduction in PSUR
preparation time
0
Deadline misses
since implementation
Quantitative Outcomes
| Metric |
Before ArcaScience |
After ArcaScience |
| Average PSUR prep time |
16–20 weeks |
6–8 weeks |
| Near-deadline submissions (<48hrs) |
22% of PSURs |
0% |
| PRAC query rate |
Baseline |
45% reduction |
| FTEs dedicated to PSUR prep |
180+ across hubs |
75 (58% reduction) |
| Products with automated generation |
0 |
300+ |
| Annual PV operations savings |
Baseline |
$12M annually |
"The transformation has been remarkable. We went from constant deadline pressure and inconsistent quality to a streamlined process that produces better PSURs in a fraction of the time. ArcaScience didn't just automate our existing process—they helped us reimagine what enterprise PV operations could look like."
— SVP, Global Drug Safety, Novartis
"The 45% reduction in PRAC queries tells the real story. It's not just about speed—the quality and consistency of our PSURs has improved dramatically. Our safety scientists can now focus on what matters most: evaluating signals and protecting patients."
— Head of Regulatory Operations, Novartis
Key Takeaways
- Enterprise-scale PSUR automation is achievable and delivers transformative efficiency gains across portfolios of any size.
- Zero deadline misses demonstrates that automation eliminates the compliance risk inherent in manual preparation processes.
- The 45% reduction in PRAC queries indicates that automated PSURs meet or exceed the quality of manually prepared documents.
- Freeing 100+ FTEs from document preparation enables reallocation to higher-value scientific analysis and signal evaluation.
- The $12M annual savings represents clear ROI and enables Novartis to invest in enhanced pharmacovigilance capabilities.
Ready to Transform Your Pharmacovigilance Operations?
Learn how ArcaScience can automate PSUR preparation and enterprise pharmacovigilance across your product portfolio.
Schedule a Consultation |
info@arcascience.ai