Helios EDC: Electronic Data Capture

Our proprietary clinical data capture ecosystem, validated per FDA 21 CFR Part 11 and GAMP 5 guidelines.

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Validated and Compliant by Design

21 CFR Part 11

CDISC Member

ISO 27001

Platform Features

Built for Clinical Excellence

Study Designer

Drag-and-drop CRF builder with pre-built templates, allowing rapid study setup and flexible form design tailored to your protocol requirements.

Real-Time Data

Live dashboards and automated queries provide instant visibility into study progress, data quality metrics, and site performance.

User Access Management

Role-based access control with granular permissions ensures data security while enabling efficient collaboration across study teams.

Remote Monitoring

Source data verification (SDV) tools and remote monitoring capabilities streamline the monitoring process and reduce site burden.

Secure Validation Packages

Complete IQ/OQ/PQ validation packages with documented test scripts, ensuring full compliance with regulatory requirements.

Ultimate Flexibility

Large file uploads including MRI and imaging data, plus configurable workflows, custom edit checks, and adaptable study designs that support complex protocols across all therapeutic areas.

Randomization & IMP Supply

Built-in randomization supporting simple, block, and stratified designs with double-blind capabilities, plus interactive IMP and drug supply management (IRT/IWRS).

Post-Market Surveillance (MDR)

Dedicated MDR module for medical device post-market surveillance, enabling continuous performance and safety data collection per EU MDR requirements.

Compliance & Validation

Computerized System Validation

Helios EDC is fully validated in accordance with FDA 21 CFR Part 11 and GAMP 5 guidelines. Our comprehensive validation approach ensures data integrity, security, and regulatory compliance throughout the clinical trial lifecycle.

FDA 21 CFR Part 11 compliant electronic signatures and audit trails

GAMP 5 risk-based validation approach with complete documentation

Full audit trail capturing every data change with timestamps and user identification

Electronic signatures with meaning statements and signature manifestations

Validated backup, recovery, and archival procedures

Role-based security with password policies and session management

GAMP 5 V-Model

Medical Devices

MDR Post-Market Surveillance

Helios EDC includes a dedicated module for Medical Device Regulation (MDR) post-market surveillance. Collect and manage post-market clinical follow-up (PMCF) data, track device performance, and generate periodic safety update reports (PSURs), all within a single validated platform.

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See Helios EDC in action. Schedule a personalized demo with our team to explore how our platform can accelerate your clinical trials.

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