TrackableHealth.AI turns wearable device data into reliable, continuous evidence that improves monitoring, strengthens endpoints, and supports earlier, more personalized intervention across every phase of your trial.
Wearables surface signals before self-reporting does
Regulatory
Ready Output
21 CFR Part 11 · ICH E6(R3) · CDISC capable
The Challenge
Why Continuous Monitoring Matters
Raw wearable data is only useful if it is cleaned, standardized, and made interoperable. Paper-based assessments introduce recall bias, data gaps, and compliance failures. AI platforms that normalize device feeds and resolve data quality issues help clinical teams use the data reliably.
“AI platforms that normalize device feeds, resolve data quality issues, and organize the information for analysis help clinical teams use the data reliably in trials.”
Unlike traditional AI tools that rely on humans to initiate queries, Trackable Health enables event-driven GenAI activation based on real-world changes the system flags a problem before a patient needs to report.
Platform Capabilities
Everything You Need In One Platform
Continuous Wearable Data Collection
Passive, real-world data from commercially available and clinical-grade wearables. Eliminates recall bias and delivers richer longitudinal evidence than traditional PRO methods.
Earlier Adverse Event Detection
Wearable signals surface potential adverse events before they are reported through traditional channels protecting participants and triggering immediate site notification.
Improved Treatment Response Measurement
Shows how patients function in daily life, not just during scheduled assessments producing more accurate measurements across the full continuum of the participant experience.
Improved Adherence and Engagement
Participants are already using devices they understand, and are more willing to wear, reducing friction and improving sustained engagement across trial duration.
Reduced Self-Report Bias
Replaces subjective symptom reporting with objective wearable measurements reducing bias that can compromise endpoint validity and regulatory submission integrity.
Usable, Interoperable Data
Our AI normalizes device feeds, resolves data quality issues, and organizes information so clinical teams can use the data reliably in every trial, every time.
Regulatory-Ready Output
CDISC CDASH-formatted datasets, 21 CFR Part 11 compliance, and ICH E6(R3) GCP alignment built in from day one capable.
Decentralized Trial Support
Full support for fully decentralized and hybrid trial designs expanding eligible populations and reducing operational costs.
Results
What the Evidence Shows
Peer-reviewed research confirms that wearable-enabled monitoring can detect physiological changes earlier than traditional self-reporting (PRO) methods. TrackableHealth.AI makes that science operationally deployable.
Wearable signals without the burden of self-reporting
Evidence
Continuous
Real-world daily-life data not periodic snapshots
Compliance
21 CFR ready
Part 11 and ICH E6(R3) GCP capable
How It Works
Simple to Deploy. Powerful in Practice.
From enrollment through to regulatory submission TrackableHealth.AI provides continuous intelligence at every stage, configured to your protocol and therapeutic area.
1
Digital Enrollment and Baseline
Participant on-boarded digitally through apps. Wearable paired, baseline biometrics captured without a mandatory site visit if protocol allows.
2
Continuous Passive Monitoring
HRV, sleep, activity, SpO2, and ePRO data collected passively 24/7. Automated reminders prompt participants to complete scheduled assessments.
3
AI Safety and Compliance Analysis
Real-time adverse event detection and protocol deviation flagging run continuously. Sites receive prioritized alerts the moment a threshold is crossed.
4
Retention Intervention When Needed
At-risk participants flagged with recommended actions and all interventions logged and tracked for protocol compliance documentation.
5
Regulatory-Ready Export
Clean CDISC-formatted datasets, full audit trails, and 21 CFR Part 11-compliant records exported for submission packages capability.
Get In Touch
Request a Demo
We will give you a live walk-through tailored to your organization’s size and current systems.
