EDC

Octalsoft EDC (Electronic Data Capture) is a clinical trial data management system designed for sponsors, CROs, and site teams. It supports data entry, real-time validation, and study management across early- and late-phase trials, including multilingual and multi-site global studies. The system is built to meet regulatory standards including 21 CFR Part 11, GCP, and GDPR.

The platform is part of the broader Octalsoft eClinical Suite and integrates with companion modules including CTMS, IWRS/RTSM, ePRO, and imaging to provide unified data workflows across the full trial lifecycle.

Intuitive Data Capture

• User-friendly interface designed to streamline data entry for site staff.
• Real-time edit checks to minimize errors at the point of capture.
• Configurable eCRFs that adapt to diverse clinical research protocols.
• Supports multilingual, multi-site, and global trial environments.
• Applicable to both early- and late-phase EDC requirements.

Study Setup and Database Build

• Drag-and-drop CRF design tools to accelerate trial startup.
• Automated compliance checks performed during study setup.
• Reusable libraries of forms and edit checks available across studies.
• Designed for faster go-live with scalability and regulatory confidence.

Real-Time Data Validation and Cleaning

• Built-in edit checks and range validations to reduce data queries.
• Automated discrepancy management to support higher data quality.
• Reconciles data from labs, ePRO, and external systems.
• Compliant with global data integrity standards.

Mid-Study Protocol Amendments

• Supports mid-study amendments without system downtime.
• Version control and audit trails maintain compliance and traceability.
• Protocol updates can be applied without disrupting existing subject data.

Reporting and Clinical Trial Dashboards

• Interactive dashboards display enrollment status, queries, and site performance.
• Custom reports highlight protocol deviations and emerging trends.
• Visual analytics available for sponsors and CROs to support decision-making.
• Export-ready reports formatted for regulators and stakeholders.

Role-Based Benefits

• Sponsors: Real-time oversight of trial data and site performance through centralized monitoring; built-in quality controls to support study integrity.
• CROs: Standardized, scalable processes for managing multiple sponsor studies; reduced manual data cleaning across studies from early-phase to global Phase III.
• Site Teams: Simplified data entry workflows with user-friendly tools designed to reduce errors and improve accuracy from start to finish.

Add-On Integrations

• Octalsoft IWRS/RTSM: Connects subject randomization and supply data with the EDC platform for full trial visibility.
• Octalsoft ePRO: Enables patients to submit data remotely, with automatic syncing to the EDC system for real-time data access.

Octalsoft EDC is supported by 24/7 customer support, personalized onboarding, and ongoing optimization services. The system is designed to comply with 21 CFR Part 11, GCP, and GDPR, and is positioned as part of an all-in-one eClinical platform covering planning, operations, data capture, and analytics across the trial lifecycle.