The CTMS Integration feature enables seamless interoperability between DecenTrialz and your organization’s existing Clinical Trial Management System (CTMS). By integrating participant pre-screening data, referral outcomes, and site-level activity logs, this functionality allows Sponsors and CROs to maintain centralized oversight of study performance across decentralized workflows, without duplicating efforts or compromising data fidelity.

Our integrations are fully compliant with HIPAA, ICH-GCP, and 21 CFR Part 11 requirements, and are designed to support both standardized and custom CTMS environments.

What CTMS Integration Enables

When enabled, CTMS integration allows you to:

1. Sync Pre-Screening Metrics

• Automatically push match data, eligibility status, and referral outcomes into designated CTMS fields
• Track participant interest trends by geography, demographic segment, or study protocol

2. Import IRB & Site Information

• Pull trial metadata (e.g., protocol ID, IRB approval dates, study phase) from your CTMS to streamline trial setup on DecenTrialz
• Reduce manual data entry across platforms

3. Centralize Consent Documentation

• Export timestamped consent logs from DecenTrialz into your CTMS for compliance archiving
• Ensure all referral-related documentation is centrally accessible

4. Enable Cross-Platform Dashboards

• Combine DecenTrialz participant flow metrics with CTMS-based operational KPIs
• Visualize recruitment health in one place without sacrificing granularity

Supported Integration Methods

DecenTrialz offers multiple options to accommodate varying CTMS architectures:

• Secure API-based Integration (REST/JSON) for real-time data sync
• Flat-file Syncs via SFTP or secure cloud storage (e.g., AWS S3) on a daily or scheduled basis
• Custom Middleware Connectors for enterprise-grade platforms like:
  • Medidata CTMS
  • Oracle Siebel CTMS
  • Veeva Vault CTMS
  • IBM Clinical Development
  • OpenClinica and others

Integration format and frequency can be customized based on your organization’s data governance policies and IT capabilities.

Integration Setup Process

To initiate CTMS integration, follow these steps:

1. Submit a Request via your Sponsor or CRO Admin account under Settings > Integrations.
2. Provide CTMS Specifications, including endpoint URLs, field mappings, and authentication method.
3. Our integration team will schedule a secure onboarding call to configure and validate data flows.
4. You will receive sandbox access for User Acceptance Testing (UAT).
5. Upon successful testing and documentation approval, integration will be activated in production.

All integrations are monitored via automated health checks and alerts to ensure sustained data accuracy.

Governance and Compliance

• Role-based access controls prevent unauthorized data transfer.
• All integrated data is encrypted at rest and in transit.
• Access logs are retained in accordance with sponsor SOPs and regulatory timelines.
• CTMS-linked fields are clearly marked in DecenTrialz dashboards for traceability.

Important: No participant identifiable data will be transferred unless explicitly approved through your IRB documentation and consent protocols.

Key Note: Integrating CTMS with DecenTrialz streamlines your digital trial ecosystem, reduces redundancy, and enhances real-time visibility across recruitment workflows. Our integrations are built with regulatory compliance at the core, enabling a unified and audit-ready infrastructure for modern clinical trials.