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AI Engineering for Drug Safety

We automate ICSR case processing, signal detection across thousands of reports, and aggregate report assembly — built and operated for you.

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What We Automate

We don't know every problem in your operation. You do. These are the types of work we engineer AI for. You tell us where it hurts most.

Data Entry Automation

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Your team re-types data from one system to another. We eliminate that.

ICSR intake MedDRA coding case narratives

Incoming Request Processing

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Safety reports come in from everywhere in every format. We read, classify, and route them.

adverse event reports literature cases spontaneous reports

Risk & Anomaly Detection

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Patterns hiding in your safety data that your team can't catch at scale. AI finds them.

signal detection case clustering trend analysis

Report & Document Drafting

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Aggregate reports and periodic safety updates assembled from case data automatically.

PSURs / PBRERs DSURs aggregate reports

Compliance & Audit Readiness

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Every PV inspection is a fire drill. We keep you ready all the time.

GVP compliance REMS tracking inspection readiness

Report & Dashboard Consolidation

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Case volumes, processing times, and compliance metrics consolidated into one view.

case backlog dashboards timeline compliance KPI reporting
See How We Work →
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Common Questions About AI for Drug Safety

How do we start?
We start with a 2-week AI Roadmap. Our engineers spend time inside your pharmacovigilance operation — watching your team process ICSRs, mapping your signal detection flows, measuring your case volumes. The output is a ranked list of workflows by ROI, with implementation timelines and expected savings. No commitment to build beyond the roadmap.
What does my team do differently on day 1?
Almost nothing. The first workflow runs alongside your existing process — AI processes incoming safety reports in parallel while your team works normally. Once accuracy is validated (typically 2-3 weeks), we switch over. Your team starts reviewing AI-processed cases instead of manually entering every field. The transition is gradual, not a big bang.
How does this work with our safety database?
We build on top of your existing systems. We integrate with Argus, ArisGlobal, and every major safety database. The AI layer connects systems that don't talk to each other today. Your IT team keeps managing infrastructure. We build the automation that sits between your systems.
What about regulatory reporting timelines?
Every workflow we build respects your reporting timelines. For expedited reports, the AI processes and prepares the case — your safety team reviews and submits. We maintain audit trails for every automated step. The AI doesn't make causality assessments; it eliminates the manual data entry around case processing.
How do we measure success?
We define success metrics with you before building anything. Typical metrics: ICSR processing time, case backlog reduction, signal detection coverage, and aggregate report preparation time. We set up dashboards that show before/after in real-time. If the numbers don't improve within 90 days, we fix it on our dime.
What's the total cost for year 1?
Two options. Per Workflow: $25K-$75K per workflow, best for starting with one high-impact process like ICSR intake or aggregate report assembly. Dedicated Team: ~$22K/month for 2+ AI engineers embedded in your operation, building multiple workflows continuously. Most PV teams start with one workflow, prove the ROI, then move to a dedicated team.

Your case backlog won't shrink with more headcount.

Book a free 30-minute AI Assessment. We'll map your highest-volume PV workflows and show you the 3 processes with the highest ROI.

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