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SmartEDC

AI-Enhanced Electronic Data Capture

The intelligent EDC platform with AI-native capabilities. Build studies in days, not months. From no-code eCRF design to database lock and export, SmartEDC handles the full data capture lifecycle with 21 CFR Part 11 compliance built into every feature.

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Everything You Need for Clinical Data Capture

A complete EDC platform with the features research teams need, built on modern technology with enterprise-grade security.

No-Code eCRF Builder

Design eCRFs with drag-and-drop. Dynamic JSONB forms with conditional logic and version control.

Visit Schedule Engine

Define longitudinal visit schedules with time windows, ordered sequences, and CRF associations.

Part 11 E-Signatures

Signatures with printed name, date/time, meaning, and re-authentication. Fully compliant.

Immutable Audit Trails

Every change recorded with user, timestamp, IP, old/new values. No update or delete permissions.

Query Management

Full lifecycle: Open, Answered, Closed. Priority levels, assignment, and resolution tracking.

Role-Based Access Control

Eight built-in roles with granular permissions. Site-scoped data isolation.

Real-Time Dashboard

Live enrollment tracking, CRF completion rates, open query counts, and study progress.

REST API + OpenAPI

Every feature via documented REST API with Swagger UI. Integrate with any system.

Edit Checks Engine

Cross-field and cross-form validation rules with range, consistency, and custom checks. Real-time feedback on data entry.

Auto-Query Rules

Define rules that automatically generate queries when data fails edit checks or required fields are missing.

Source Data Verification

Field-level SDV tracking for monitors. Verify, flag discrepancies, and track verification progress remotely.

Database Lock

Progressive locking workflow — site-level and study-level locks with full audit trail and approval controls.

Informed Consent

eConsent with version control, re-consent tracking on protocol amendments, and withdrawal management.

Randomization Engine

Stratified block randomization with treatment arms, sealed schemes, and controlled unblinding.

Adverse Event Capture

AE/SAE reporting with severity grading, causality assessment, outcomes, follow-ups, and safety reports.

Lab Data Management

Lab panels with normal ranges, out-of-range flagging, and central lab integration support.

Data Export Engine

CDISC ODM, CSV, and custom exports with background processing and secure download management.

eCRF Builder

3-panel drag-and-drop form designer with field library, canvas preview, and live property editing.

Coming Q4 2026

Intelligence at Every Step

Six AI capabilities launching soon — designed to reduce manual work, catch errors earlier, and accelerate your timelines.

80% faster study builds

Protocol-to-eCRF AI

Upload your protocol PDF. AI extracts visit schedules, CRF fields, and edit checks. Go live in days.

85%+ accuracy

AI Auto-Coding

MedDRA and WHO Drug Dictionary suggestions with confidence scores. Learns from corrections.

40% fewer queries

Anomaly Detection

ML models flag outliers and errors at the moment of entry, not days later.

30% faster resolution

Smart Query Generator

Context-aware queries that explain the issue and suggest resolution.

50%+ time saved

EHR-to-EDC Assistant

AI extracts data from source documents and maps to CRF fields for review.

Proactive management

Enrollment Forecasting

Site and study-level projections with confidence intervals.

Compliance Built In, Not Bolted On

Every feature is designed with regulatory requirements from the start — not retrofitted as an afterthought.

21 CFR Part 11

FDA electronic records and signatures compliance

GDPR

EU data protection and privacy regulation

HIPAA

US health information privacy and security

ICH-GCP E6(R2/R3)

International good clinical practice guidelines

ISO 27001

Security controls aligned with ISO 27001

SmartEDC Questions

Technical details and common questions about SmartEDC.

SmartEDC supports all phases of clinical trials (Phase I through Phase IV), observational studies, and registries. It handles complex longitudinal visit schedules, multi-site multi-country deployments, and provides the regulatory compliance controls required for FDA-regulated trials.

The eCRF builder uses a drag-and-drop interface where you define form fields, types (text, numeric, date, dropdown, radio, checkbox, calculated), conditional logic, and validation rules. Forms are stored as dynamic schemas, so no code changes or deployments are needed to create new CRF types.

SmartEDC supports CDISC ODM export (validated against the published schema), CSV/Excel export, and SDTM variable mapping. Exports include full audit trail metadata and are submission-ready for regulatory authorities.

Electronic signatures comply with 21 CFR Part 11 sections 11.50 and 11.100. Each signature captures the signer's printed name, date and time, meaning of the signature, and requires re-authentication with username and password. Signatures are cryptographically bound to the record they sign.

Locked CRFs cannot be modified — this is by design for regulatory compliance. To make changes, a Data Manager must unlock the entry (which creates an audit trail record), the change is made with a documented reason, and the entry goes through the verification and locking workflow again.

Request a demo from our sales team and we'll walk you through the platform. Once you're ready, choose a plan that fits your needs. Our onboarding team will help you configure your first study and train your staff. Most teams are operational within days.

Ready to Transform Your Clinical Trials?

Join leading research organizations using PharmaTrialsCortex to accelerate their trials.

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