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Fundanet CTMS Studio v.1 – AI-Powered Protocol Intelligence for Azure

Fundanet CTMS Studio v.1 is an Azure-native AI platform that transforms unstructured clinical trial protocols into structured, auditable, and CTMS-ready datasets. It automates the extraction of study design elements such as arms, phases, visits, cycles, procedures, schedules, and operational rules, significantly reducing manual configuration effort and implementation risk.

What Fundanet CTMS Studio v.1 Does

• Extracts structured study metadata from PDF protocols
• Identifies arms, cohorts, phases, and randomization schemes
• Builds visit schedules and cycle definitions
• Maps procedures to visits with evidence traceability
• Generates auditable outputs ready for CTMS ingestion
• Preserves source references with page-level evidence offsets

All extracted data is traceable back to source documentation, enabling full auditability and validation workflows. This makes StudyForge suitable for hospital research units, CROs, sponsors, and data management teams operating in regulated environments.

Security Architecture

Fundanet CTMS Studio v.1 is built on Azure-native infrastructure and follows enterprise-grade security principles:

• Deployment within customer-controlled Azure subscriptions
• Private networking support (VNet integration)
• Role-based access control (RBAC)
• Encryption at rest and in transit (TLS 1.2+)
• Secure storage using Azure-managed services
• Full activity logging and audit traceability

The platform is designed to operate under GDPR and high-risk AI governance frameworks, supporting compliance with EU AI Act requirements where applicable.

Personal Data Minimization & Sanitization

Fundanet CTMS Studio v.1 incorporates strict data minimization principles. During document ingestion:

• Personal identifiers (names, emails, phone numbers, addresses) are detected and removed
• Free-text sections are analyzed for potential personally identifiable information (PII)
• Only protocol-relevant structural data is preserved
• Raw documents can be optionally excluded from long-term storage

The system focuses exclusively on study design and operational metadata. It does not require patient-level data to perform protocol structuring. This significantly reduces privacy exposure and attack surface.

Designed for Regulated Environments

Fundanet CTMS Studio v.1 supports compliance-driven workflows by combining deterministic parsing, evidence-backed AI extraction, and validation layers. Outputs are structured, versioned, and suitable for controlled environments requiring documentation and reproducibility.

By automating protocol structuring while maintaining auditability and security, StudyForge reduces implementation time, lowers operational risk, and improves data consistency across clinical trial systems.