eDOCS

Octalsoft eDOCS is a cloud-based electronic document management system (EDMS) designed for clinical research organisations, sponsors, and site teams. It uses AI-driven automation to handle document categorisation, version control, compliance tracking, and e-signatures, with the goal of keeping trial documents audit-ready while reducing manual administrative work.

The platform supports all clinical trial document types — regulatory, site, patient, and operational — and is built to maintain consistency across global, multi-site studies. It is designed to meet regulatory standards including ICH-GCP, 21 CFR Part 11, EMA, FDA, HIPAA, and GDPR.

Core Capabilities

• Centralized Digital Repository: Secure, cloud-based storage accessible anytime and from any location. AI-driven categorisation and metadata tagging enable instant document retrieval across all trial document types.
• Intelligent Version Control: Automated versioning prevents outdated or duplicate files from circulating. AI detects discrepancies between document versions, and full audit trails capture edits, approvals, and e-signatures.
• Seamless Collaboration: Role-based access controls are available for sponsors, CROs, and site teams. AI identifies bottlenecks in review and approval workflows, and real-time alerts keep distributed teams aligned.
• Automated Compliance Tracking: AI flags missing, expired, or non-compliant documents. Automated reminders cover renewals such as IRB approvals, CVs, and training records. Audit-ready reports can be generated instantly.
• eSignatures and Secure Authentication: Supports legally binding electronic signatures with AI-powered identity verification. Eliminates reliance on paper storage, printing, and manual filing processes.

Role-Specific Benefits

• Sponsors: Centralised oversight provides visibility and control over all trial documents. Automated audit trails and version control reduce compliance risks, and streamlined workflows accelerate regulatory and ethics submissions.
• CROs: Standardises documentation processes across studies and clients. AI-driven dashboards support proactive identification and resolution of compliance issues. Automated categorisation, tagging, and filing reduce manual effort.
• Site Teams: Reduces administrative workload and supports continuous audit readiness, allowing site staff to focus more on patient care and trial execution.

Add-ons and Integrations

• Octalsoft eConsent: Patient consents can be stored and tracked directly within eDOCS.
• Octalsoft CTMS: Trial documents can be linked to study milestones for operational oversight.
• eClinical Suite Integration: eDOCS connects with CTMS, eConsent, rSDV, EDC, and IWRS modules, providing unified oversight across the full trial lifecycle.

Platform and Support

• Designed to comply with global regulatory standards including 21 CFR Part 11, ICH-GCP, EMA, HIPAA, and GDPR.
• Offered as part of Octalsoft's broader eClinical suite, covering planning, operations, data capture, and analytics.
• Includes personalised onboarding, 24/7 support, and ongoing optimisation services.

Octalsoft eDOCS is deployed as a cloud-based solution and functions as an integrated component of the Octalsoft eClinical ecosystem, making it suitable for organisations seeking a unified platform for clinical trial document management alongside other trial operations tools.