Study data collection, automated.

Automatically generate eCRFs and source documents from your protocol, automate source data entry to enable truly remote monitoring, and ensure full 21 CFR Part 11 compliance.

Everything you need to build, capture, and monitor your clinical data.

Legacy systems are just digital paper. Harbor automates the busywork, from the moment you draft the protocol to the final database lock, so you can focus on the science.

Demographics

Demographics

DM.BRTHDT
DM.AGE
DM.SEX
DM.SEXDEC
Magic Build

Protocol-to-EDC in Minutes

Stop waiting weeks for database builds. Harbor's Magic Build engine parses your protocol PDF and automatically generates CRFs and source documents instantly.

YSI 2300 STAT PLUS

-----Sample Report------
ID:MANUAL-000012
W: Glucose110 mg/dL
B: Glucose111 mg/dL
Fri 17/05/2415:32:52
-------------------------

In-Clinic Day

Blood Draw #1

Magic Capture

Automated Data Capture

Sites upload source documents, and Harbor's AI extracts the data directly into the EDC—cutting transcription time by 90% and reducing errors.

Remote Monitoring

Vitals Form
Temp (°F)
98.60.98
Heart Rate (bpm)
720.98
BP Systolic
1880.41
SourcePage 2
Source document scan
Magic Monitor

Risk-Based, Remote Monitoring

View source documents side-by-side with EDC data from anywhere in the world. Each data point is scored for extraction confidence and clinical relevance, enabling centralized and risk-based monitoring without forcing sites to change their workflows.

Built for efficiency

Unblock your trial at every stage.

Legacy EDCs create bottlenecks with slow builds, manual entry, and delayed data access. Harbor removes the friction, compressing months of busywork into minutes of automation.

10 Minutes

To generate a full EDC build. Upload your protocol PDF and get a draft CRF and source document packet instantly. No more 8-week build delays.

90%

Reduction in manual data entry. Sites upload source docs, and AI handles the transcription. Turn 2 hours of typing into 15 minutes of review.

Real-time

Data visibility. Zero latency. See source data the moment it is uploaded, rather than waiting 7-10 days for site entry.

StartSiteSponsor

Creating source documents and CRFs used to be a standalone, two-month project for us. With Harbor, the system generated them automatically as part of the EDC build, cutting that entire process down to just two days. It streamlined our study startup phase significantly.

Johnny Chen

Johnny Chen

Founder & CEO, BioDynamik

Security

Security is our baseline, not a feature.

Harbor is architected from the ground up to meet the most stringent requirements of the FDA, HIPAA, and sponsor IT teams.

Regulatory Ready

Compliance Stack

We do not just support compliance; we enforce it. Harbor creates a validated environment with immutable audit trails, eSignatures, and role-based access controls by default.

21 CFR Part 11HIPAAGDPR
Validation

Validation Package Included

Skip the 6-month validation headache. We provide a comprehensive Verification and Validation package with every license, including risk and traceability matrices.

Infrastructure

Military-Grade Encryption

Your data is encrypted at rest using AES-256 and in transit via TLS 1.2+. Each study is hosted in logically isolated databases to prevent cross-contamination.

Resilience

Business Continuity

Our infrastructure runs on multi-zone redundancy with automated daily backups. In the event of a catastrophic regional failure, your trial data is safe and recoverable within minutes.

Data Use

Zero Data Retention

Your organization’s data is only used for the clinical trials you run. We maintain zero-data retention and enforce business associate agreements (BAA) with all partners to ensure privacy, security, and compliance.

Questions & Answers

One platform. All the features.

We do not gate automation behind a paywall. Every Harbor license includes our full suite of AI tools: Magic Build, Magic Capture, and Magic Monitor.

Academic & Non-Profit

Free

University research and investigator-initiated trials.

  • Full AI suite (Build, Capture, Monitor)

  • Unlimited users and patients

  • Standard support (email)

  • Standard export

Commercial Study

Starting at $2,000/mo

Growing teams needing collaboration and insights

  • Everything in Academic

  • 21 CFR Part 11 validation package

  • Priority support (Slack channel)

  • Training for sites and CRAs

  • Guaranteed uptime SLA

Enterprise / CRO

Volume pricing

CROs and sponsors with 3+ active trials.

  • Everything in Commercial

  • Master service agreement (MSA)

  • SSO / SAML

  • CTMS / eTMF integrations

  • Dedicated customer success manager

Everything Included

  • Magic Build: Protocol-to-CRF automation.

  • Magic Capture: AI source data entry.

  • Magic Monitor: Confidence scores to enable risk-based and remote monitoring.

  • ePROs: Patient data entry.

  • Storage: Unlimited source document uploads.

Ready to modernize your clinical data collection?

Stop settling for slow builds and manual entry. Schedule a personalized demo to discuss your specific protocol requirements and see how Harbor can reduce your trial timelines.

Contact sales