Category: Data & Integrations

The API Access & Controls feature allows Sponsors and Contract Research Organizations (CROs) to programmatically interact with DecenTrialz using secure, standards-compliant application programming interfaces (APIs). This enables automation of trial workflows, real-time data exchange with internal systems, and integration with third-party analytics, recruitment tools, or electronic data capture (EDC) platforms ,  all while maintaining strict regulatory compliance.

APIs are available only to authorized organizations under signed data use agreements and are designed in accordance with HIPAA, and industry-standard security protocols.

Core API Capabilities

Approved Sponsor and CRO teams may use the DecenTrialz API to:

1. Fetch Trial-Level Data

• Retrieve real-time trial metadata (protocol ID, study phase, IRB status)
• Access site assignments and current trial status (e.g., Draft, Live, Paused, Closed)

2. Extract Pre-Screening Metrics

• Programmatically access match rates, eligibility breakdowns, and participant funnel trend
• Export timestamped referral logs and pre-consent interactions (if permitted by consent)

3. Push or Pull Site and Trial Updates

• Update site status, IRB document versions, or recruitment notes from your system to DecenTrialz
• Sync eligibility logic, study messages, or multilingual content (requires elevated permissions)

4. Monitor Participant Activity (Pre-Referral Only)

• Track pre-screener starts, completions, and dropout points
• Visualize region-specific engagement trends via API endpoints for mapping tools or dashboards

Access & Authentication

To ensure maximum security and traceability:

• All API access requires OAuth 2.0 authentication
• API keys are time-bound and role-restricted, issued only to Sponsor/CRO Admin accounts
• Each request is encrypted and logged in your organization’s digital audit trail
• Rate limits and access scopes are enforced to prevent abuse or unauthorized data pulls

Note: Participant health records, contact details, or PII are never accessible via public APIs unless IRB-approved and authorized via documented consent pathways.

Requesting API Access

Organizations interested in API access must:

1. Submit a request via the “Integrations” tab in your Sponsor or CRO Admin dashboard.
2. Undergo a brief API Readiness & Compliance Review conducted by DecenTrialz.
3. Sign the API License & Data Use Agreement, outlining permitted use cases and technical responsibilities.
4. Receive test credentials for sandbox integration, followed by production access upon validation.

Integration Use Cases

Common API usage scenarios include:

• Embedding DecenTrialz data into custom dashboards (e.g., PowerBI, Tableau)
• Automating participant match reports into sponsor CRMs
• Real-time monitoring of trial engagement KPIs across decentralized sites
• Connecting recruitment data to clinical operations platforms

Key Note: API access empowers sponsors and CROs to build a more flexible, automated, and insight-driven clinical trial infrastructure. However, such access comes with compliance responsibilities. DecenTrialz enforces strict access controls, consent safeguards, and real-time monitoring to ensure participant trust and regulatory adherence are never compromised.

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.

The Exporting Trial Data feature allows Sponsors and Contract Research Organizations (CROs) to securely download pre-screening data associated with a specific clinical trial or set of trials. This functionality is essential for performance analysis, internal reporting, compliance documentation, and integration with external tools such as statistical software, data warehouses, or clinical trial management systems (CTMS).

All exports are governed by strict role-based access controls and follow HIPAA, ICH-GCP, and 21 CFR Part 11 requirements for data protection, traceability, and regulatory readiness.

What Types of Data Can Be Exported

Only data collected during the pre-screening phase may be exported from the DecenTrialz platform. This includes:

1. Participant Funnel Metrics

• Number of matches generated
• Pre-screener completion status
• Eligibility outcomes (Pass / Ineligible / Requires Review)
• Time-to-completion statistics

2. Consent Records

• Timestamped consent logs for referral authorization
• Participant opt-in or opt-out status for future communications
• Record of IRB-approved language shown to the participant

3. Geographic and Demographic Data (De-identified)

• General location data (e.g., state or city)
• Age range, gender, or other demographic filters (if collected and IRB-approved)
• Data visualized by region or site

4. Participant Flags

• Skipped questions
• Inconsistent responses
• Referral readiness status

Note: No protected health information (PHI) or personally identifiable information (PII) will be included unless (a) the export is approved by the Sponsor’s data governance lead and (b) explicitly authorized under the trial’s IRB documentation.

Available Export Formats

Sponsors and CROs may select from the following formats when exporting trial data:

• .CSV – Standard comma-separated spreadsheet format
• .XLSX – Excel-compatible file with preformatted headers
• .PDF – Summary data in printable format, suitable for inclusion in sponsor reports or IRB documentation
• .JSON – Machine-readable data structure for software integrations or API use cases

Steps to Export Data

1. Log in using an account with export permissions (Sponsor Admin or CRO Project Lead).
2. Navigate to the trial dashboard and select “Export Data.”
3. Apply filters as needed (e.g., date range, eligibility outcome, site).
4. Choose export format and whether to include metadata (e.g., site name, timestamps).
5. Authenticate via 2FA and confirm export.
6. A download link will be generated or emailed to the authorized account.

All export activity is logged in the audit trail for regulatory transparency.

Security and Compliance Measures

• Export permissions are tightly role-restricted and monitored.
• All downloads are encrypted in transit and time-limited.
• Every data export is logged, timestamped, and stored in your site’s audit history.
• Any export containing sensitive flags or risk-indicative metadata is reviewed by platform compliance before download is released (where required).

Key Note: Exported trial data provides crucial visibility for sponsors and CROs to evaluate progress, troubleshoot bottlenecks, and maintain regulatory audit readiness. However, data access must be balanced with confidentiality and ethical safeguards. DecenTrialz ensures that all exports adhere to IRB-approved guidelines and participant consent limitations.