The Reality of Drug Safety Today
Pharmacovigilance teams face relentless volume pressures, compressed reporting timelines, and fragmented data sources. Traditional approaches leave you in a perpetual state of reactive firefighting rather than proactive risk management.
Signal Detection Overload
Manual signal detection across global databases consumes 70% of your team's bandwidth, leaving little capacity for strategic safety analysis. Critical signals can be missed in the noise, and you're always playing catch-up with emerging safety concerns.
PSUR Production Bottleneck
12-16 week PSUR cycles require dedicated medical writing resources and multiple review rounds, creating a perpetual production burden. Every periodic report becomes a major organizational lift, pulling resources from higher-value activities.
Fragmented Safety Data
Safety signals scattered across FAERS, EudraVigilance, literature, and internal databases with no unified analytical view. Building a comprehensive benefit-risk picture requires manual data wrangling across disconnected systems.
Your Workflow, Transformed
Continuous Global Safety Surveillance
Our Data Intelligence module monitors safety data continuously across all major sources, running automated disproportionality analyses and prioritizing signals based on clinical relevance. You gain a unified analytical view that would take months to assemble manually.
- Continuous monitoring across FAERS, EudraVigilance, literature databases, and real-world evidence sources
- Automated disproportionality analysis using PRR, ROR, BCPNN, and IC methods with full statistical reporting
- Clinical context enrichment for signal prioritization based on severity, seriousness, and outcome patterns
- Historical trend analysis to distinguish emerging signals from background noise
Structured Benefit-Risk Assessment for Signal Evaluation
Transform raw signals into structured benefit-risk assessments using quantitative frameworks aligned with regulatory expectations. Every decision is audit-trailed, every judgment is documented, and every assessment follows a consistent methodology.
- Quantitative benefit-risk frameworks for signal evaluation (BRAT, MCDA, PrOACT-URL)
- Risk characterization with incidence rate estimation and causal assessment support
- Comparative safety profiling against class benchmarks and therapeutic alternatives
- Audit-trailed analytical decisions with full provenance from raw data to conclusion
PSUR/PBRER Generation in Days, Not Months
From comprehensive data analysis to submission-ready documents, ArcaScience automates the entire periodic reporting workflow. What used to take 12-16 weeks now takes days, freeing your team to focus on strategic safety decision-making.
- Automated PSUR/PBRER generation aligned with ICH E2C(R2) requirements
- Risk Management Plan (RMP) updates with automated safety specification sections
- Signal assessment reports with complete statistical appendices and literature summaries
- Submission-ready formatting for EMA, FDA, and other regulatory authorities
Impact for Drug Safety Teams
"ArcaScience transformed our periodic reporting from a quarterly burden into a strategic advantage. What used to take our team 14 weeks and required multiple CRO contracts now takes 5 days. More importantly, the comprehensive signal detection catches issues we would have missed entirely with manual methods. We've shifted from reactive firefighting to proactive safety intelligence."
Sanofi Dermatology: Accelerating Benefit-Risk Assessment for Post-Marketing Surveillance
Sanofi's dermatology pharmacovigilance team used ArcaScience to transform their PSUR production and signal detection workflow. By integrating global safety databases and automating disproportionality analysis, they reduced PSUR cycle time by 60% while identifying 9x more clinically relevant signals than their previous manual approach.
Deepen Your Understanding
AI-Driven Signal Detection: Beyond Disproportionality Analysis
How machine learning identifies clinically meaningful signals 9x more effectively than traditional statistical methods.
Download →From 14 Weeks to 5 Days: Transforming PSUR Production at Sanofi
Inside the pharmacovigilance workflow transformation that eliminated the quarterly PSUR bottleneck.
Read →Proactive Pharmacovigilance: Strategic Signal Management in 2025
Learn how leading pharma companies are shifting from reactive monitoring to proactive safety intelligence.
Watch →