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Use CaseICSR & Adverse Event Processing

Autonomous Pharmacovigilance AI AgentsAI Agents for ICSR & Adverse Event Processing

Deploy AI agents that ingest adverse event reports from all channels — literature, HCP calls, patient portals, social media — auto-code with MedDRA, assess causality and generate submission-ready E2B(R3) XML for EMA, FDA and global health authorities.

About ICSR & Adverse Event Processing

ICSR & Adverse Event Processing solutions powered by autonomous AI agents enable enterprises to overcome the pharmacovigilance processing crisis. Our ICSR automation AI platform provides comprehensive automation for end-to-end automated case processing. Trusted by Fortune 500 companies and leading enterprises worldwide for mission-critical icsr & adverse event processing operations. Deploy AI-powered agents that work 24/7 to transform your icsr & adverse event processing workflows with enterprise-grade security, compliance, and scalability.

Key capabilities include multi-source ingestion: emails, pdfs, call transcripts, literature, patient portals, automated meddra pt/llt coding with confidence scoring and audit trail, causality assessment and seriousness classification per ich e2a guidelines, automated generation of e2b(r3) xml for eudravigilance, faers and vigibase. Organizations achieve 80% Faster Case Processing, Consistent MedDRA Coding Quality, and Scalable Safety Operations through our intelligent automation platform.

Purpose-built autonomous agents, tailored to your stack.

Problem and Solution Overview

The friction today

The Pharmacovigilance Processing Crisis

Drug safety teams drown in case volume while regulatory clocks tick. Manual ICSR processing is slow, inconsistent, and increasingly unsustainable as product portfolios grow.

Common challenges in icsr & adverse event processing include high operational costs, slow processing times, manual errors, and scalability limitations. Traditional approaches to icsr & adverse event processing struggle with exponential growth in icsr volume from digital channels, literature and patient communities, leading to inefficiencies and missed opportunities. Organizations face increasing pressure to modernize icsr & adverse event processingoperations while maintaining compliance and reducing costs.

  • Exponential growth in ICSR volume from digital channels, literature and patient communities
  • Manual MedDRA coding is inconsistent across different coders and geographies
  • 15-day and 7-day expedited reporting deadlines create constant operational pressure
  • High cost of maintaining global PV teams proportional to product portfolio size
With Alomana agents

End-to-End Automated Case Processing

Alomana agents ingest reports from all sources, extract structured case data, perform MedDRA coding, determine reportability by market, and generate E2B(R3) submissions — with human-in-loop review for complex cases.

Alomana's icsr & adverse event processing AI agents provide end-to-end automation with enterprise-grade reliability. Our platform leverages advanced machine learning, natural language processing, and intelligent process automation to deliver 80% Faster Case Processing. The solution integrates seamlessly with existing systems including ERPs, CRMs, and legacy applications. Real-time monitoring, audit trails, and compliance reporting ensure governance and transparency. Scalable architecture supports growing workloads without performance degradation.

  • Multi-source ingestion: emails, PDFs, call transcripts, literature, patient portals
  • Automated MedDRA PT/LLT coding with confidence scoring and audit trail
  • Causality assessment and seriousness classification per ICH E2A guidelines
  • Automated generation of E2B(R3) XML for EudraVigilance, FAERS and VigiBase

See it in motion

See the agents working on your behalf

Watch how autonomous agents orchestrate data extraction, reasoning and reporting on complex, real-world workloads.

Turn your proprietary data into value

Autonomously analyzes databases, discovers anomalies, and extracts insights from your data

Jade is an autonomous AI data analysis agent that discovers anomalies, generates predictive insights, and automates database analysis across your enterprise systems. Key features include fraud detection, automated reporting, real-time data monitoring, and advanced analytics for business intelligence.
$1M Fraud Prevented

in the last 12 months for one of the largest global servicers across $5B+ in transactions processed.

Data Upload

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Outcomes

What teams achieve with this use case

Organizations implementing icsr & adverse event processing AI agents achieve significant improvements across key metrics. Benefits include reduced operational costs, faster processing times, improved accuracy, enhanced compliance, and better scalability. Real-world deployments demonstrate measurable ROI within weeks of implementation. Teams report higher productivity, reduced manual work, and ability to focus on strategic initiatives. The platform supports continuous improvement through machine learning and adaptive algorithms. Enterprise customers benefit from dedicated support, custom integrations, and tailored deployment options including on-premises and cloud-based solutions.

01

80% Faster Case Processing

Reduce median case processing time from days to hours, eliminating backlogs and meeting all expedited reporting deadlines without overtime.

02

Consistent MedDRA Coding Quality

Standardise coding decisions across global PV operations with auditable reasoning, reducing variability and QC rejection rates.

03

Scalable Safety Operations

Process 10x case volume without proportional headcount growth — enabling lean safety teams to manage growing portfolios.

Questions, answered

Frequently asked questions

How do AI agents handle MedDRA coding quality and review?

Agents apply MedDRA coding with confidence scores and flag low-confidence cases for human review. All coding decisions are logged with full reasoning trails, enabling QC review and continuous calibration against your organisation's coding conventions.

Can agents handle literature monitoring as a source for ICSRs?

Yes. Agents continuously monitor PubMed, Embase and grey literature sources, extract valid ICSRs meeting ICH E2A criteria, and route identified cases directly into the processing pipeline — eliminating manual literature review.

Do agents integrate with safety databases like Argus or ARISg?

Alomana integrates with major safety databases including Oracle Argus, ARIS g, Veeva Vault Safety and Informatica MDM — pushing structured case data and E2B files into your existing safety system of record.

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