We partner with pharmaceutical and pharmacovigilance organizations to co-develop AI agent solutions tailored to their operations — from adverse event intake to regulatory submission. Your challenges, our engineering.
Our Approach
Every pharmacovigilance operation is different. We work closely with your team to design and build the exact AI agents your workflows demand.
We meet with your safety, regulatory, and operations teams to map your current workflows, pain points, and compliance requirements.
Together, we architect an agent system tailored to your processes — which agents you need, how they connect, and where humans stay in the loop.
We develop, test, and validate each agent against your real-world data and regulatory standards. Nothing ships without your sign-off.
As your needs change — new therapeutic areas, new markets, new regulations — we build additional agents and refine existing ones alongside you.
Agent Orchestration
Every agent system we build is unique to the client. Below is an example configuration — yours could look entirely different depending on your needs.
An example configuration. We design agent topologies specific to your workflows, data sources, and regulatory landscape.
What We Build
These are the kinds of agents we develop with our clients. Each one is adapted to the specific systems, standards, and workflows of the organization we're working with.
Ingests ICSRs from EHRs, literature, social media, call centers, and patient portals. Deduplicates, structures, and normalizes data automatically.
Always listeningClassifies incoming cases by severity, seriousness, and expectedness. Routes urgent cases to human reviewers within seconds.
< 2s routingMaps adverse events to MedDRA terminology at PT, LLT, HLT, and SOC levels with 98.4% accuracy. Suggests alternatives for ambiguous terms.
98.4% accuracyEvaluates drug-event relationships using WHO-UMC and Naranjo algorithms. Generates confidence scores with complete reasoning chains.
Explainable AIContinuously monitors aggregate data for emerging safety signals using PRR, ROR, and Bayesian methods. Alerts teams to new patterns.
Real-time monitoringGenerates E2B(R3) compliant ICSR reports, PSURs, and DSURs. Submits directly to EMA, FDA, and 150+ global health authorities.
150+ authoritiesThese are starting points, not a fixed set. We build whatever agents your operation needs — literature monitoring, patient follow-up, benefit-risk assessment, regional compliance, and beyond.
Tell us what you needHow It Works
Once deployed, your agents handle the full ICSR lifecycle autonomously. Every decision is traceable, every handoff is logged.
Results
The agents we build with our clients consistently outperform manual workflows on the metrics that matter most to safety teams.
Agent Collaboration
Deploy our foundational agents for intake, triage, coding, causality, signal detection, and reporting. Operational in days, not months.
Agents hand off tasks, share context, and work in parallel. They escalate to humans when confidence thresholds aren't met.
Build custom agents for literature monitoring, patient follow-up, benefit-risk assessment, or any workflow unique to your organization.
Add agents to new therapeutic areas, geographies, or data sources. The platform adapts to your pharmacovigilance operation as it grows.
Tell us about your pharmacovigilance challenges. We'll show you what AI agents can do for your specific operation.