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AI Engineering for CRO Regulatory

We automate multi-sponsor submissions, safety report preparation, agency correspondence tracking, and regulatory compliance — 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.

Document Generation

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Submission packages and regulatory documents assembled automatically.

eCTD submissions safety narratives annual reports

Incoming Request Processing

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

agency correspondence sponsor requests safety signals

Compliance & Audit Readiness

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

submission tracking timeline compliance safety reporting deadlines

Regulatory Monitoring

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Rules change constantly. We track them so your team doesn't miss a deadline.

FDA guidance EMA updates ICH guidelines

Data Entry Automation

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

RIMS entries submission metadata safety database updates

Reporting & Consolidation

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Multi-sponsor regulatory data pulled together so leadership sees one picture.

submission pipelines deadline dashboards resource allocation
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Common Questions About AI for CRO Regulatory

How do we start?
We start with a 2-week AI Roadmap. Our engineers spend time inside your regulatory operation — watching your team assemble submission packages across multiple sponsors, mapping your agency correspondence tracking, measuring your safety report preparation cycle. 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 assembles submission components or tracks correspondence in parallel while your team works normally. Once accuracy is validated (typically 2-3 weeks), we switch over. Your regulatory team starts managing strategy instead of documents. The transition is gradual, not a big bang.
How does this work with our regulatory systems?
We build on top of your existing systems. We integrate with Veeva Vault RIM, LORENZ docuBridge, and every major RIMS and publishing platform. The AI layer connects your regulatory systems across multiple sponsors and submissions. Your IT team keeps managing infrastructure. We build the automation that sits between your systems.
What about multi-sponsor submission requirements?
Every workflow we build handles the complexity of serving multiple sponsors with different requirements. The AI adapts submission formatting, document standards, and quality expectations to each sponsor's specifications. We maintain audit trails for every automated step. The AI doesn't make regulatory decisions; it eliminates the manual work around preparation.
How do we measure success?
We define success metrics with you before building anything. Typical metrics: submission assembly time, safety report turnaround, correspondence response speed, and regulatory query resolution 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 submission assembly or safety report automation. Dedicated Team: ~$22K/month for 2+ AI engineers embedded in your operation, building multiple workflows continuously. Most CRO regulatory teams start with one workflow, prove the ROI, then move to a dedicated team.

Your operations are too complex for manual processes.

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

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