AI eCRFCRF Studio — Turn Protocols into CRFs

AI eCRF

CRF Studio Turn Protocols into CRFs

Turn your protocol into a CRF.
Design, validation, and AI-assisted drafting in one workspace

19design elements 18clinical templates 10real-time checks

ai.e-crf.kr

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1 What is CRF Studio?

CRF Studio is an eCRF workspace where study teams directly design and validate protocol visits, sections, and fields.
Edit like Google Docs, structure with drag and drop, and connect 18 clinical templates, CDISC·CDASH support, AI-assisted CRF drafts, and DQC in one flow.

Who is it for?

🏥

CRO CRF Designer

Quickly design different CRFs for each trial and modify them instantly when the protocol changes.

👨‍⚕️

Principal Investigator (PI)

Design CRFs tailored to your study objectives and review them directly at the data entry site.

📊

Data Manager (DM)

Apply CDASH standards from the design phase and verify data quality in real time.

💊

Sponsor / Monitor

Monitor CRF design status and completeness in real time, and export to Excel/PDF for submission.

Why was it created?

💸

Reduce Outsourcing and Repeat Costs

Let study teams design and revise directly to reduce external development queues and repeat-edit costs.

⏱️

Move Faster from Protocol Review to CRF Draft

The time from protocol to completed CRF is dramatically reduced.

✏️

Unlimited Free Edits

No need to call a developer to change a single phrase. Fix it in seconds.

🔒

Client Data Security

All CRF data is stored securely on domestic servers. No risk of overseas cloud leaks.

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2 Problems with the Old Way — How CRF Studio Solves Them

🔴 Pain Points of the Old Way:
Every CRF design required a developer → cost incurred.
Even minor text changes incurred additional costs.
Same process repeated every time the protocol changed.

🟢 CRF Studio's Solution:
Drag and drop to complete a CRF. Zero cost.
Undo and auto-save enable unlimited free edits.
Reuse with templates and section library.

Old Way	CRF Studio	Benefit
CRF design = developer-dependent, high cost	Drag & drop to design directly	Less development dependency
Any text change = extra cost	Double-click → edit instantly	Lower repeat-edit costs
Rebuilt from scratch per trial	Reuse with templates & library	Shorter design cycles
Manual CDASH compliance check	40+ standard variables built-in, auto-suggest	No standard omissions
Errors found only after data entry	Real-time detection at design stage	Errors prevented upfront
Days to weeks to complete a CRF	Basic CRF ready instantly	Speed revolution

💡 Transformation at a Glance:
Reduce outsourcing and repeated handoffs so study teams can draft and review CRFs directly and move faster.

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3 Core Features — Design & Editing

📐

Up to 19 Design Elements

Text, number, date, select, yes/no, checkbox, progress, file attachment, signature — all clinical CRF expressions supported. CDASH mapping complete.

🖱️

3-Level Drag & Drop Design

Intuitive Visit → Section → Item structure. Complex multi-visit CRFs are easy to design with just a mouse.

🔤

★ Inline Direct Editing (Google Docs Style)

Double-click to edit section names, item names, and options directly. Enter to save, Esc to cancel. No popup windows needed.

📋

★ Duplicate — at Every Level

One-click duplication for visits, sections, and items. Section duplication copies all internal items, conditions, and styles.

📂

★ Section Library

Save frequently used sections to your personal library and drag them into other CRFs for reuse. Zero repetitive work.

📋

18 Built-in Clinical Templates

IC, DM, VS, AE, CM, LB, EG, PE and more — 18 CDISC-standard templates. No need to start from a blank page.

🔀

Condition Settings + Connection Visualization

Conditional show/hide/required rules like 'Show drug name only when BP med = Yes'. Visual arrows and ⚡ badges show connections.

👁️

Full CRF Preview

Browse all visits and sections in tabs exactly as subjects will see them. Verify as you design.

📑

Collapse/Expand Sections (Accordion)

Collapse sections to save space and expand only what you need. Essential for large CRFs.

📅

Visit Schedule Management

Visit type, required status, visit day, allowable window, full timeline. Design visit schedules exactly as in the protocol.

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4 Smart Convenience Features

↩️

Undo / Redo (30 Steps)

Ctrl+Z (undo) / Ctrl+Y (redo) to freely recover from mistakes.

💾

Simultaneous Auto-Save

Auto-saves as you type. Work preserved even if you close the browser or lose connection.

🔍

Search & Filter

Instantly find items by name among 100+ fields.

📦

Multi-Select & Batch Operations

Select multiple items with Shift/Ctrl → delete or move in one action.

⌨️

Keyboard Shortcuts

Ctrl+S save, Delete remove, Space collapse, Ctrl+C/V copy/paste.

🛡️

Error Prevention + Auto-Recovery

Content preserved even on unexpected errors. Recovery prompt on reconnection.

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5 Export, Management & Validation

📄

Excel Export (with CDASH Variables)

Export the entire CRF structure to Excel with automatic CDASH standard variable mapping (AETERM, CMTRT, etc.). For sponsor and regulatory submission.

🖨️

Print / Save as PDF

A4-optimized CRF output. Supports paper CRF submission requirements. Save directly as PDF.

🔄

Version Control + Change History Diff

A new version is automatically created on every save. Compare changes between versions with highlighting, and revert to previous versions. Satisfies GCP Audit Trail requirements.

🏷️

40+ Built-in CDASH Standard Variables

Built-in international clinical trial standard variable names such as AETERM, CMTRT, VSORRES, DMAGE. Automatically recommends suitable variables when adding sections.

📱

Tablet Design & Mobile Review

Continue CRF design on tablets, and review CRF structures and data-entry screens on smartphones at the study site.

♿

Healthcare Web Accessibility Compliance

Full keyboard navigation and screen reader support. Complies with healthcare institution information accessibility regulations.

⚡

Fast Editing for Large CRFs

Smoothly edit large CRFs with 200+ items without lag.

🛡️

Error Prevention + Auto-Recovery

Work in progress is preserved even on unexpected errors or internet disconnection. On reconnection, prompts to restore previous work.

Real-Time Design Validation — 10 Types

⚡ 10 Real-Time Validations Before Saving

① Missing section title detection

② Empty query highlighting

③ Unset response format warning

④ Broken condition reference display

⑤ Missing required visit detection

⑥ Empty visit notification

⑦ Required field check

⑧ Missing option validation

⑨ Duplicate title detection

⑩ Real-time issue counter badge

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6 DQC — Data Quality Control

🎯 DQC (Data Quality Control) is a dual validation system that applies CRF Studio's validation rules in real time during subject data entry and combines AI medical analysis.

🔗 Validation Flow — Design → Entry → Verify → Save

Step	Description	Method
① Subject Entry Instant Validation	When subject data is entered, rules configured in CRF Studio (min/max values, units, required fields, conditions, date constraints) are applied in real time. Cells that violate criteria are highlighted with guidance messages.	Rule-Based
② DQC Rule-Based 1st Pass	A first-pass validation using basic rules before AI analysis. Violations of design-stage rules trigger immediate warnings — reducing unnecessary AI calls and lowering costs.	Rule-Based
③ DQC AI 2nd Pass	Only data that passes rule validation is further analyzed by AI from a medical perspective. Detects drug interactions, adverse event patterns, and medical outliers based on 15 medical reference sources.	AI Inference
④ Severity Classification	Design rule violations are classified as Critical Error, and AI inference results as Reference Note. Filter by severity level for review.	Rule+AI Combined
⑤ Server Double Validation	Validation rules are verified once more on the server to ensure data is stored safely. Data that violates criteria is blocked from saving, with an exception procedure allowing saves with a documented reason when unavoidable.	Server Validation
⑥ Auto-Execute on Save	DQC runs automatically as soon as subject data is saved. A real-time notification appears with "🟡 N items to verify" — no need to run it separately.	Automated

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7 AI DQC — Continuous Enhancement Plan Roadmap

Beyond current rule+AI integrated validation — evolving into more sophisticated AI data verification

Drug-Adverse Event Pattern Learning	Automatically learns drug-symptom association patterns from accumulated adverse event (AE) data. Early warnings are provided when similar patterns are detected in new data.
Automatic Protocol Deviation Detection	Detects deviations of actual data from visit and dosing schedules. Auto-alert: "Suspected missed Day 14 dose."
Cross-Study Comparative Analysis	Comparative data analysis across trials with similar protocols or the same drug class. Automated outlier and trend reports.

Roadmap capabilities will be introduced in stages using approved de-identified data and within each institution's permitted scope.

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8 AI-Powered CRF Draft Generation

🧠 AI-Powered CRF Design Support

Available — Available now

Upload a protocol document and AI will automatically generate a CRF draft.

📤

① Upload Protocol

Clinical Protocol (PDF/Word/Text)

🧠

② AI Analysis

Visit, Assessment & Criteria Analysis

📋

③ Generate CRF Draft

Structure + CDASH Mapping Suggestions

✏️

④ Review & Edit

Finalize in CRF Studio

Expected Impact: AI proposes visits, assessments, and CDASH mappings from the protocol so study teams can start with a structured draft and focus on review and refinement.

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9 Comparison with Competing Tools

Feature	REDCap	Castor	Medrio	CRF Studio
Full GUI Design	✅	✅	✅	✅
Up to 19 Design Elements	Partial	Partial	Partial	✅ Complete
Inline Direct Edit (Double-Click)	❌	❌	❌	✅
Section Library & Duplication	Limited	Limited	Limited	✅ Full Support
3-Level Drag & Drop Editing	△	✅	✅	✅
10 Real-Time Validation Types	Limited	Limited	Limited	✅ Instant Display
DQC (Rule + AI Integrated Validation)	❌	❌	❌	✅ Proprietary
AI Natural Language CRF Draft Generation	❌	❌	❌	✅ Available
40+ Built-in CDASH Standards	Partial	❌	❌	✅
Version Control + Diff	Limited	✅	✅	✅
Excel/PDF Export	✅	✅	✅	✅ CDASH Tags Included
Template Marketplace	Shared Library	❌	❌	✅
18 CDISC Standard Templates	❌	❌	❌	✅
Mobile & Tablet Support	Partial	✅	✅	✅
Full Korean + Domestic Regulatory Compliance	❌	❌	❌	✅

* Based on each product's official public materials as of August 2026. Feature scope may vary by plan, version, and deployment environment.

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10 Built-in Clinical Templates — 18 Types

18 clinical templates based on CDISC standards are built in. Each template comes pre-configured with visit schedules, item structures, CDASH variable mappings, and range validation rules — ready to use or adapt with minimal edits.

📝

Informed Consent (IC)

Subject Consent, Explanation & Signature

👤

Demographics (DM)

DOB, Gender, Race, Height, Weight

💓

Vital Signs (VS)

BP, Pulse, Temp, RR — Multi-Visit

⚠️

Adverse Events (AE)

Symptom, Severity, Causality, Action — Multi-Visit

💊

Concomitant Medications (CM)

Drug Name, Dose, Duration — Multi-Visit

🧪

Laboratory Tests (LB)

Hematology, Urinalysis, Chemistry — Multi-Visit

🩺

Medical History (MH)

Past History, Surgical History, Family History

❤️

ECG (EG)

HR, PR, QRS, QTc, Interpretation

🔬

Physical Exam (PE)

Systemic Exam & Abnormal Findings

📊

Screening, End of Visit & 9 Others

Screening, Enrollment, Completion, Follow-up & More

✨ Usage Example:
"Need a CRF for a hypertension trial?" → Load Vital Signs (VS) + Concomitant Medications (CM) + Adverse Events (AE) + Laboratory (LB) templates and combine → Complete in 5 minutes.

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Built Together

Capturing the voices from clinical trial sites —
"A tool to design CRFs yourself"
becomes one connected workflow in CRF Studio.

Now CRF design is with fewer development queues and handoffs,
study teams can design directly.

Design it yourself, validate in real time, and bring it into your trial faster.

AI eCRF — CRF Studio

ai.e-crf.kr

Start with CRF Studio Service inquiry

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