EDC

Harbor EDC is a clinical trial electronic data capture platform designed to automate study data collection from protocol ingestion through to database lock. It is built for sponsors, CROs, academic institutions, and investigator-initiated trial teams who need to reduce manual data entry, accelerate study startup, and maintain regulatory compliance with 21 CFR Part 11, HIPAA, and GDPR.

The platform centers on three core automation modules — Magic Build, Magic Capture, and Magic Monitor — which together address the main bottlenecks in traditional EDC workflows: slow database builds, manual transcription of source data, and delayed or on-site monitoring requirements.

Protocol-to-EDC Automation (Magic Build)

• Parses a protocol PDF and automatically generates draft CRFs and source document packets.
• Reduces database build time from a typical 8–12 weeks to approximately 10 minutes for an initial draft.
• Eliminates the need for a separate, standalone source document and CRF creation project during study startup.

Automated Data Capture (Magic Capture)

• Sites upload source documents directly to the platform; AI extracts data and populates EDC fields automatically.
• Targets a 90% reduction in manual data entry, converting approximately two hours of transcription work into roughly 15 minutes of review.
• Reduces transcription errors by removing manual re-entry of source data.

Risk-Based and Remote Monitoring (Magic Monitor)

• Displays source documents side-by-side with EDC data, accessible from any location.
• Each data point is assigned an extraction confidence score and a clinical relevance score to support risk-based monitoring decisions.
• Enables centralized monitoring without requiring sites to change their existing workflows.
• Provides real-time data visibility with no latency from the moment source documents are uploaded.

Additional Platform Capabilities

• ePRO support for direct patient data entry.
• Unlimited source document storage across all license tiers.
• Immutable audit trails, eSignatures, and role-based access controls enforced by default.
• Query management and source page review tools within the monitoring interface.

Security and Compliance

• Compliant with 21 CFR Part 11, HIPAA, and GDPR.
• Data encrypted at rest using AES-256 and in transit via TLS 1.2+.
• Each study is hosted in a logically isolated database to prevent cross-study data contamination.
• Infrastructure runs on multi-zone redundancy with automated daily backups and recovery capability following regional failures.
• Zero data retention policy: organizational data is used only for the trials being run on the platform.
• Business associate agreements (BAA) enforced with all partners.
• A Verification and Validation package, including risk and traceability matrices, is included with every commercial license.

Pricing Tiers

1. Academic and Non-Profit (Free): Covers university research and investigator-initiated trials; includes the full AI suite, unlimited users and patients, standard email support, and standard data export.
2. Commercial Study (from $2,000/month): Adds 21 CFR Part 11 validation package, priority Slack-based support, site and CRA training, and a guaranteed uptime SLA.
3. Enterprise / CRO (volume pricing): Designed for CROs and sponsors running three or more active trials; adds a master service agreement, SSO/SAML, CTMS and eTMF integrations, and a dedicated customer success manager.

Harbor is a cloud-hosted platform that supports external CRO and sponsor collaboration. All three automation modules are included across every license tier without additional gating. The platform is positioned as an alternative to legacy EDC vendors such as Medidata, Viedoc, and Veeva, with a focus on faster deployment timelines and lower cost of entry.