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in Clinical Trials

SmartEDC is PharmaTrialsCortex's AI-enhanced Electronic Data Capture platform for clinical trials. It provides a no-code eCRF builder, visit schedule engine, query management, electronic signatures, immutable audit trails, adverse event capture, lab data management, randomization, and data export — all compliant with 21 CFR Part 11, GDPR, and HIPAA from day one.

Yes. Compliance is built into the architecture, not bolted on. SmartEDC includes immutable audit trails with field-level change tracking, electronic signatures with printed name, date/time, meaning, and re-authentication, role-based access control with 8 built-in roles, 15-minute session timeouts, password policies with Argon2 hashing, and account lockout after failed attempts. Every feature is tested against Part 11 requirements in our automated compliance test suite.

Our Protocol-to-eCRF AI agent reads your study protocol PDF and extracts visit schedules, CRF fields, eligibility criteria, and edit checks automatically. The AI generates a draft study configuration that you review and refine using the no-code eCRF builder. This reduces study build time from 10-12 weeks to days, letting your team focus on science instead of configuration.

PharmaTrialsCortex is built for regulatory-grade security. We implement 21 CFR Part 11 compliant electronic records and signatures, GDPR data protection controls including field-level PII encryption and consent management, and HIPAA-aligned safeguards for protected health information. Our security architecture is designed to support SOC 2 and ISO 27001 certification. All clinical data is encrypted at rest (AES-256) and in transit (TLS 1.3) with field-level PII encryption.

Yes. PharmaTrialsCortex provides a comprehensive REST API with full OpenAPI documentation, making it straightforward to import study configurations and data from other EDC systems including REDCap, Medidata Rave, and OpenClinica. Our services team provides migration support to ensure a smooth transition with zero data loss.

Request a demo from our team and we will walk you through the platform. You can start a free 14-day trial at app.pharmatrialscortex.com — no credit card required. Our documentation covers everything from initial setup to configuring your first study, and our customer success team is available to help you get up and running quickly.