Post-Marketing Surveillance
Continuous Benefit-Risk Monitoring for Marketed Products
Automated PSUR/PBRER generation, signal management, and RMP updates — grounded in 100+ billion data points.
After marketing authorization, the benefit-risk profile of a product continues to evolve as real-world use generates new safety and effectiveness data. ArcaScience's platform supports pharmacovigilance and regulatory teams with continuous benefit-risk monitoring, automated generation of PSUR/PBRER and RMP documents aligned with ICH E2C(R2) and EMA GVP Module V, and signal detection across spontaneous reporting, literature, and real-world evidence. The platform ensures that periodic assessments are consistent, comprehensive, and produced on timelines that regulatory calendars demand.
The Challenge
Why Periodic Benefit-Risk Assessment Remains Resource-Intensive
Post-marketing pharmacovigilance is a continuous obligation that scales with the number of marketed products, markets, and reporting requirements. PSUR/PBRER production cycles — spanning data lock points, interval and cumulative safety analysis, medical writing, multi-stakeholder review, and regulatory submission — consume weeks of specialized resources per product per cycle. Signal management workloads grow with increasing spontaneous reporting volumes from FAERS, EudraVigilance, and literature monitoring. RMP maintenance requires evolving safety specifications and pharmacovigilance plan updates. Regulatory expectations from EMA's proactive pharmacovigilance emphasis and FDA's post-marketing commitments continue to intensify. For organizations with portfolios of multiple marketed products across multiple markets, overlapping timelines create persistent resource pressure.
PSUR/PBRER Production Burden
Each PSUR/PBRER cycle requires data lock point management, interval and cumulative safety data integration, benefit-risk evaluation, medical writing, and iterative review. For a portfolio of 20+ products, this creates a continuous production pipeline that strains PV teams.
Signal Detection at Scale
Growing volumes of spontaneous reports, literature publications, and real-world evidence require continuous monitoring. Traditional signal detection applied only at PSUR data lock points misses emerging signals between assessment periods.
RMP & Label Change Complexity
Risk Management Plans require ongoing updates as new safety data accumulates. Label change requests demand comprehensive evidence packages assembled under tight regulatory timelines. Each update must maintain consistency with prior assessments.
How ArcaScience Addresses This
One Platform from Development Through Post-Marketing
Continuous Signal Detection
Automated monitoring of FAERS, EudraVigilance, published literature, and real-world evidence sources. Disproportionality analysis (PRR, ROR, BCPNN) applied continuously — not just at PSUR data lock points. New signal identification, assessment, and tracking from detection through evaluation to resolution, integrated with internal pharmacovigilance systems.
Periodic Benefit-Risk Evaluation
The benefit-risk framework established during development carries forward into post-marketing without re-creation. Decision Intelligence produces the ICH E2C(R2)-aligned benefit-risk evaluation section for each PSUR/PBRER cycle, incorporating interval safety data, cumulative safety data, and updated benefit evidence. Historical assessments are preserved with full audit trail continuity.
PSUR/PBRER, RMP & Signal Reports
Automated PSUR/PBRER document generation aligned with ICH E2C(R2), with signal summary auto-populated from the signal management workflow. RMP updates aligned with EMA GVP Module V, including safety specification updates, pharmacovigilance plan adjustments, and risk minimization measure effectiveness assessments. Label change evidence packages assembled from the platform's analytical outputs.
Workflow
How It Works
Continuous Signal Monitoring
The Data Intelligence Engine monitors FAERS, EudraVigilance, literature, and RWE sources continuously, applying PRR, ROR, and BCPNN disproportionality analyses to identify emerging safety signals between PSUR cycles.
Data Lock & Benefit-Risk Evaluation
At each PSUR data lock point, the platform integrates interval safety data, cumulative safety data, and updated benefit evidence. Decision Intelligence produces the structured benefit-risk evaluation aligned with ICH E2C(R2).
Generate PSUR/PBRER & RMP Updates
Automated document generation produces the complete PSUR/PBRER with signal summaries auto-populated from the monitoring workflow. RMP safety specification and pharmacovigilance plan sections are updated in parallel.
Submit & Support Label Changes
Submit regulatory-ready documents to FDA, EMA, and PMDA. When safety findings warrant label changes, the platform assembles the evidence package and benefit-risk justification for the proposed modification.
Case Study — GSK
PSUR Automation for a Multi-Product Portfolio
GSK deployed ArcaScience's platform to automate PSUR/PBRER production across a portfolio of marketed products. The platform's continuous signal monitoring identified safety-relevant findings between data lock points that manual periodic review had not surfaced. PSUR production timelines were reduced from weeks to days per product cycle, with signal summaries auto-populated and benefit-risk evaluation sections generated directly from the analytical framework.
Read Full Case Study →Director of Pharmacovigilance
GSK — Post-Marketing Surveillance Program
Related Solutions
Benefit-Risk Analysis Across the Lifecycle
Early Development
Phase I-II signal detection, DDI screening, comparator profiling, and early benefit-risk framing.
Late Development & Submission
CTD Module 2.5, advisory committee preparation, integrated benefit-risk summary for regulatory submission.
Market Access & HEOR
Value dossiers, HTA submission support, comparative effectiveness evidence, payer communication materials.