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AI Engineering for CRO Clinical Ops

We automate site feasibility, enrollment tracking, monitoring visit reports, and TMF management — 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.

Incoming Request Processing

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

sponsor requests site documents safety reports

Data Entry Automation

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

CTMS updates eTMF filing site tracking enrollment logs

Document Generation

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Reports and study documents assembled from clinical data automatically.

monitoring visit reports feasibility reports trip reports

Compliance & Audit Readiness

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

GCP compliance TMF inspection readiness SOP adherence

Risk Detection

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

enrollment risk site performance data quality issues

Reporting & Consolidation

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Multi-study data pulled together so leadership sees one picture.

study dashboards CRA productivity sponsor metrics
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Common Questions About AI for CRO Clinical Ops

How do we start?
We start with a 2-week AI Roadmap. Our engineers spend time inside your clinical operation — watching your team manage site feasibility, mapping your enrollment tracking process, measuring your monitoring visit report 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 processes site assessments or monitoring reports in parallel while your team works normally. Once accuracy is validated (typically 2-3 weeks), we switch over. Your CRAs start managing sites instead of writing reports. The transition is gradual, not a big bang.
How does this work with our CTMS?
We build on top of your existing systems. We integrate with Medidata, Oracle Clinical, Veeva, and every major CTMS platform. The AI layer connects your CTMS, eTMF, EDC, and sponsor portals. Your IT team keeps managing infrastructure. We build the automation that sits between your systems.
What about sponsor-specific requirements?
Every workflow we build handles the complexity of multi-sponsor operations. The AI adapts to each sponsor's reporting templates, quality standards, and SOPs. We maintain audit trails for every automated step. The AI doesn't make clinical decisions; it eliminates the manual work around documentation and reporting.
How do we measure success?
We define success metrics with you before building anything. Typical metrics: site activation timeline, monitoring visit report turnaround, enrollment tracking accuracy, and TMF completeness score. 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 monitoring visit reports or site feasibility assessments. Dedicated Team: ~$22K/month for 2+ AI engineers embedded in your operation, building multiple workflows continuously. Most CROs 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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