rSDV

Octalsoft rSDV is a remote source data verification system designed for sponsors, CROs, and clinical trial site teams. It supports the verification of source data against EDC entries from any location, aiming to maintain data accuracy, regulatory compliance, and monitoring efficiency without requiring on-site visits.

The platform incorporates AI-assisted workflows, risk-based monitoring, and secure remote access to source documents. It is built to comply with HIPAA, GDPR, 21 CFR Part 11, and GCP requirements, and integrates natively with other components of the Octalsoft eClinical suite including EDC, CTMS, IWRS, and ePRO.

AI-Guided Monitoring Workflows

• AI-driven dashboards identify high-risk sites and subjects for prioritized attention.
• Source data verification tasks are prioritized based on risk assessment outputs.
• Monitors are guided through structured workflows intended to reduce redundancy.
• Supports accuracy across multiple sites simultaneously.

Secure Remote Access

• Provides controlled, encrypted access to source documents.
• Role-based permissions restrict access to authorized users only.
• AI-powered anomaly detection monitors for unauthorized activity.
• Compliant with HIPAA, GDPR, and other global privacy regulations.

Real-Time Discrepancy Management

• AI automatically flags inconsistencies between source data and EDC entries.
• Supports rapid query generation and resolution.
• Reduces the volume of manual SDV checks required.
• Supports reconciliation across labs, imaging systems, and external data sources.

Intelligent Risk-Based Monitoring (RBM)

• Integrates with centralized RBM strategies.
• AI identifies sites or patients with higher likelihood of protocol deviation.
• Monitoring visits are prioritized based on data-driven risk signals.
• Aims to reduce overall monitoring costs while maintaining compliance.

Collaboration Tools

• Secure communication channels connect CRAs, sponsors, and site staff.
• AI organizes and prioritizes outstanding issues for resolution.
• Centralized tracking covers monitoring notes, action items, and follow-ups.
• Provides shared visibility across all trial stakeholders.

Analytics and Reporting

• Customizable dashboards display site performance, query status, and SDV compliance metrics.
• AI-driven insights identify trends and flag outliers.
• Automated reporting supports decision-making for sponsors and CROs.
• Designed to accelerate trial progress through improved oversight.

Role-Specific Benefits

• Sponsors: Real-time oversight via AI dashboards, reduced monitoring costs, and support for global compliance requirements.
• CROs: Scalable monitoring operations across multiple studies, with centralized remote source document verification improving site collaboration.
• Site Teams: Reduced frequency of on-site monitoring visits, with intuitive query resolution tools and secure communication channels.

Integrations and Add-ons

• Direct integration with Octalsoft EDC enables real-time source data verification checks and query resolution.
• Integration with Octalsoft CTMS combines monitoring oversight with operational visibility across trials.
• Native connectivity with IWRS and ePRO as part of the broader Octalsoft eClinical suite.

Octalsoft rSDV is supported by 24/7 customer support, personalized onboarding, and ongoing optimization services. The platform is designed to meet global regulatory standards including 21 CFR Part 11, GCP, and GDPR across all system components.