OpenClinica AI Foundry: Your Study, Built and Ready in Days
Introducing: OpenClinica AI Foundry

Your Next Study
Built and Ready in Days.

Submit your protocol. We handle everything from build to go-live and deliver a production-ready study in OpenClinica. Your team reviews, approves, and signs off at every step.

Fully Managed Service
CFR Part 11 Compliant
CDISC ODM 1.3.x Validated
ICH E6(R3) GCP Ready
Compliance Artifacts for Your Study File

Three stages from protocol to production

You provide the protocol. We do the rest. Your data manager reviews and signs off at every step.

1
Free
Preview

We process your protocol PDF and return a complete Specification Package covering every form, visit schedule, codelist, and data point mapped out in full. See exactly what we'll build before committing to anything.

You do: Provide your protocol PDF, supporting materials, and sign an mNDA.
We do: Build the full Specification Package and deliver it within 24 hours.
$0
No cost. No commitment.
Get Your Free Specification Package →
2
Free
Demo

We take your approved spec and build your actual study into a live OpenClinica sandbox. Not a generic demo. Your forms, your visit schedule, your study. Interact with it, share it with your team, and confirm it's right before going to production.

You do: Review the sandbox and provide feedback if needed.
We do: Build, configure, and hand you access to a live OpenClinica demo environment with your study.
$0
Your study. Live. Before you pay a dollar.
Request Your Demo Build →
Production

Once you're satisfied with the demo, we work with your team to get you to go-live, with your review and approval every step of the way. We add your build to your study corpus so each future study is built smarter and tailored to your specific study design style.

You do: Gated reviews and DM sign-off.
We do: Full study build, generate compliance documentation for your study file and get your study go-live ready in days, not weeks or months.
$10,000
Flat rate. One study. Everything included.

Get Started →

The New Standard for Clinical Study Build.

Up to 94% Faster. Up to 92% Cheaper.

Traditional study builds can cost up to $125,000 and take months. Every study with AI Foundry is $10,000 flat, delivered in days.

$125K $100K $75K $50K $0 $10K $37.5K $10K Small Study $75K $10K Average Study $125K $10K Complex Study Traditional PS AI Foundry: $10,000 flat

The complexity of your study no longer determines the cost. It just determines how much you save.

Everything included. No surprises.

One price covers the complete managed engagement, from first protocol to live production study.

Specification Package PDF + XLSX
OpenClinica EDC Build, XLSForms, ready for production
DVS workbook UAT test cases
Build Preview PDF
Live OpenClinica demo environment, built around your study
Production deployment to OpenClinica
Handover documentation
DM sign-off workflow included
Your conventions captured for faster future builds
$10,000
Flat rate · One study · Full production build

Specification Package and Demo are always free. You only pay when you're ready to go to production, and you've already seen your study live in OpenClinica before committing.

One engagement covers the full scope. No hourly overruns. No per-form pricing. No surprises.

Get Your Free Specification Package →

You provide the protocol.
We handle everything else.

No build hours to manage, no forms to code. Our team does the work, you review and sign off.

Your Team
Our Team
Provide protocol PDF
Specification Package
Optional feedback between stages
Full EDC build
Review demo environment
Validation & compliance checks
 
Production deployment
🛡️

Your edits always win

Have feedback between stages? Send it. We incorporate every change before moving forward. Nothing goes to production without your approval.

🔒

Compliant at every layer

21 CFR Part 11 audit trail, ICH E6(R3) GCP documentation, and CDISC ODM validation run on every engagement.

📚

Learns how you work

Every build captures your conventions and preferences. The second study is faster than the first. The tenth is faster still.

The more we build for you,
the better we get at it.

Every engagement teaches OpenClinica AI Foundry your conventions, standards, and preferences. The next study starts smarter than the last, permanently.

📚

Learns your standards

We incorporate your CRF library, OpenClinica standards, and study conventions into every build. Your rules, not generic defaults.

📈

Builds on itself

Every correction and preference we capture becomes a rule for the next engagement. Each study we build for you is faster and requires less back-and-forth than the one before.

🔒

Your conventions, your advantage

The knowledge we build about your studies belongs to your account. It's not shared, not reset, and not available to anyone else.

The first study gets you up and running. Every study after that gets faster and simpler, automatically.

Built for regulated clinical research

Every engagement runs on a compliance framework designed for IND and NDA-ready environments. AI decisions are logged and reviewable. Human sign-off gates enforce accountability at every critical step.

🔐
21 CFR Part 11
Electronic signatures + full audit trail
📊
CDISC ODM 1.3.x
3-layer validation on every import
ICH E6(R3) GCP
Traceable inputs, reviewable AI decisions
🌍
GDPR
PII scan before transfer, no patient data outside OpenClinica

Ready to see what we'll build?

Share your protocol and we'll return a complete Specification Package within 24 hours. No cost, no commitment, just a clear picture of your study before you decide.

Your Study, Production-Ready in Days.

Free Specification Package. Free demo environment. $10,000 flat for the full production build. And every build makes the next one faster.

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