Turn weeks of manual EDC build into hours.

AI-powered protocol extraction that transforms clinical trial documents into structured EDC specifications

The Problem

40-80

Hours reading

200-page protocols

2-4

Weeks delay

to start trials

Human errors

in data capture

Expensive rework

when protocols change

The Transformation

Without

40-80 hrs

2-4 wks

With Protocol Intelligence

15 min

2-4 hrs

Upload Your Protocol

Free to try - no credit card required

Watch 90-Second Demo

See Protocol Intelligence transform a clinical trial document in real-time

Upload Protocol

Select Mode

View Output

Export to EDC

Quick Workflow

Upload Protocol: Drag and drop your clinical trial protocol PDF into the upload area.
Select Extraction Mode: Choose Fast for quick results, Detailed for thorough analysis, or Deep Research for maximum coverage.
View Hierarchical Output: Explore the extracted data organized by Events (visits), Tasks (forms), and Actions (fields) with CDISC-compliant variable names.
Export to EDC: Download your results in Excel, CSV, or JSON format ready for import into your EDC system.

Demo Standards We Follow

Problem First

We explain the pain before the solution

Before/After Value

Weeks to hours - visually obvious

Trust is a Feature

Source traceability, not blind confidence

AI Shows Uncertainty

Confidence scores, not magic promises

Complete Workflow

From input to usable output

Frictionless Trial

Sample data, preloaded examples

"A demo that extracts data but doesn't extract trust is useless."

See What You Get

Structured hierarchical data with complete source traceability

Example Extraction Output

Interactive preview of hierarchical EDC structure

CDASH Compliant

EventScreening VisitPage 18

TaskVital SignsVSPage 23

ActionMeasure Blood PressurePage 23

ActionMeasure Heart RatePage 25

TaskDemographicsDMPage 26

ActionCollect DemographicsPage 26

Event (Visit)Task (Form/CRF)Action (Field Group)Variable (Field)

Every field links back to protocol source for audit trail

How It Works

From protocol upload to EDC-ready specifications in four simple steps

Review Results

Explore the complete extraction output in an intuitive interface

Available Now

Hierarchical view of all extracted data
Source page references for each field
Confidence scores highlight uncertain items
Flag items requiring clinical review

Calculate Your Savings

See how much time and money you can save with Protocol Intelligence

Your Current Process

Protocols per year20

1100

Average pages per protocol200

50500

Hours spent per protocol (manual)60 hrs

20 hrs120 hrs

Data manager hourly rate$75/hr

$50$150

Estimated Annual Savings

93% reduction in EDC build costs

Time Saved Per Year

0 hours

That's 28 work weeks freed up

Current annual cost$90,000

With Protocol Intelligence$6,000

Start Saving Time

* Based on average 90% time reduction from manual EDC build

In Partnership With

Clinical Operations Expertise

Trialomix co-designs AI workflows that remove friction for CROs and sponsors—from proposal to trial startup, safely and at enterprise scale.

Protocol → EDC MappingTrial-Ready AutomationAudit-Friendly Lineage

Learn More

90% Time Saved

Minutes, Not Weeks

CDISC Compliant

Ready to transform yourEDC build process?

Join clinical teams who've already accelerated their trial starts

Get Started FreeUpload Your Protocol

No credit card required • Your data stays secure

Built for Regulated Environments

Enterprise-grade compliance and traceability for clinical trials

CDISC CDASH

Compliant variable naming

SDTM Ready

Direct mapping to submission datasets

Source Traceability

Every field linked to protocol source

Every extracted field includes source page reference

Audit trail of all AI decisions

Human review workflow built-in

Export validates against CDISC standards

Our strategic partnership with Trigent gives us global delivery capability, deep technical expertise, and operational scalability.

3,000+

Engineers

30+

Years of Experience

Global

Capability Centers

Capital-Efficient

Scaling

Built By

ArkOS: AI for Life Sciences

Frequently Asked Questions

Common questions about compliance, security, and capabilities

Protocol Intelligence provides audit trail and source traceability features that support Part 11 compliance. Every extraction decision is logged with timestamps and source references. Final validation is dependent on your organization's procedures and IT infrastructure.

Our extraction achieves 90-95% accuracy on standardized protocols using Gemini 2.0 Flash with native PDF understanding. All extractions include confidence scores for each field, allowing you to quickly identify items needing human validation. The accuracy improves with cleaner, more structured protocol documents.

Your protocols are encrypted in transit (TLS 1.3) and at rest (AES-256). Data is stored in secure, SOC 2 compliant infrastructure. We do not use your proprietary protocols to train AI models. You maintain full ownership and can delete your data at any time through the platform.

Extraction outputs are designed to support regulatory workflows with full CDISC CDASH compliance and SDTM traceability. Every field includes source page references for audit trail documentation. The structured output can be used as the foundation for your submission-ready datasets.

Currently, we support export to Excel workbooks (with multiple sheets for Events, Tasks, Actions, and Code Lists), CSV for data import, and JSON for system integration. Direct API integrations with Medidata Rave, Oracle Clinical, and Veeva Vault are on our near-term roadmap.

Extraction time depends on protocol length and mode selected. Fast mode takes 2-5 minutes for quick results. Detailed mode takes 10-20 minutes for thorough page-by-page analysis. Deep Research mode takes 30-60 minutes for maximum coverage with AI-enhanced extraction.

Yes, you can upload protocol amendments or specific sections. The system will extract structure from whatever content is provided. Version comparison features (coming soon) will allow you to track changes between protocol versions automatically.

The built-in review workflow allows you to edit any extracted field, add missing information, and flag items for clinical review. All changes are tracked in the audit trail. You can also re-run extraction with a more thorough mode if needed.

Ready to Get Started?

Upload your protocol document and see the AI extract structured EDC specifications in minutes, not weeks.

Upload Your Protocol

Or explore our Protocol Library to see sample extractions