Home/Industries/Biotech/Clinical Ops

AI Engineering for Biotech Clinical Ops

We automate site activation, TMF filing, protocol deviation tracking, and monitoring visit reports — built and operated for you.

Book Assessment →

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

→

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

site documents IRB/EC approvals protocol amendments

Data Entry Automation

→

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

CTMS updates TMF filing deviation logs enrollment data

Document Generation

→

Monitoring reports and study documents assembled from clinical data automatically.

monitoring visit reports site initiation packages close-out letters

Compliance & Audit Readiness

→

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

TMF completeness GCP compliance essential document tracking

Risk Detection

→

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

enrollment risk site performance issues data quality signals

Reporting & Consolidation

→

Study data pulled together so leadership sees the real picture.

enrollment dashboards site metrics study timelines
See How We Work →
Case Studies Pricing

Common Questions About AI for Biotech 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 activations, mapping your TMF filing process, measuring your protocol deviation tracking 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 documents or TMF filings in parallel while your team works normally. Once accuracy is validated (typically 2-3 weeks), we switch over. Your clinical ops team starts managing exceptions instead of processing everything manually. The transition is gradual, not a big bang.
How does this work with our CTMS and eTMF?
We build on top of your existing systems. We integrate with Veeva Vault, Medidata Rave, Oracle Clinical, and every major CTMS and eTMF platform. The AI layer connects your clinical systems, site portals, and document repositories. Your IT team keeps managing infrastructure. We build the automation that sits between your systems.
What about GCP compliance and audit trails?
Every workflow we build is designed for GCP compliance. The AI maintains 21 CFR Part 11 compliant audit trails, validates document completeness against TMF reference model, and flags deviations. We don't make clinical decisions; we eliminate the manual work around documentation and tracking.
How do we measure success?
We define success metrics with you before building anything. Typical metrics: site activation timeline, TMF completeness score, protocol deviation processing time, and monitoring visit report turnaround. 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 TMF filing or site activation tracking. Dedicated Team: ~$22K/month for 2+ AI engineers embedded in your operation, building multiple workflows continuously. Most clinical ops 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.

Book Your AI Assessment