GAO’s Clinical Trial Device Tracking Systems

Clinical Trial Device Tracking Systems enable automated identification, tracking, and management of medical devices, consumables, and test equipment used in clinical trials. The system ensures precise monitoring of asset utilisation, movement, and storage conditions. It also minimises data entry errors, enforces compliance with regulatory standards, and enhances operational efficiency. GAO Inc., headquartered in New York City and Toronto, leverages its four decades of R&D and IoT expertise to provide scalable and compliant solutions for global clinical operations.

Description, Purposes, Issues to Address, and Benefits of GAO’s Clinical Trial Device Tracking Systems

This system is designed to track critical clinical trial assets such as diagnostic kits, monitoring devices, and lab instruments across multi-site research facilities. It supports compliance with FDA 21 CFR Part 11 and GxP standards by maintaining accurate audit trails and real-time visibility.
Purposes:

• Automate device registration and utilization tracking
• Reduce manual errors and lost equipment incidents
• Improve asset utilization and chain-of-custody transparency

Issues to Address:

• Asset misplacement or loss across study sites
• Manual and error-prone tracking processes
• Difficulty ensuring regulatory compliance

Benefits:

• Real-time asset visibility across distributed sites
• Improved operational efficiency and accountability
• Enhanced data integrity and audit readiness

Comparison: RFID Alone vs BLE Alone vs Optional RFID-BLE Combination for GAO’s Clinical Trial Device Tracking Systems

RFID-Only Approach

• Ideal for deterministic checkpoint reads at device dispensing stations, calibration labs, clean storage areas, and controlled clinical supply rooms.
• Facilitates precise custody events and structured workflow monitoring.
• Best suited for environments with defined transfer points.

BLE-Only Approach

• Supports continuous, wide-area tracking for mobile equipment, subject-issued devices, and temperature-controlled assets.
• Enables dwell-time analysis, zone-level telemetry, and multi-floor equipment oversight.
• Suited for large research campuses and dynamic clinical workflows.

Optional RFID-BLE Combination

• Applied only when both precise chokepoint validation and broad-area tracking are required.
• Useful for multi-site studies involving structured dispensing workflows plus real-time device mobility.
• GAO implements this configuration only when a measurable technical advantage exists.

Applications of GAO’s Clinical Trial Device Tracking Systems

Investigational Device Custody Management
Tracks allocation, return, sterilization, and storage of investigational tools essential for clinical protocols and regulatory compliance.

Subject-Issued Device Oversight
Monitors glucose meters, wearable sensors, infusion pumps, and digital health tools assigned to trial participants.

Cold Chain Equipment Tracking
Supervises refrigerated kits, biologic sample containers, and temperature-sensitive devices critical for stability and data integrity.

Calibration and QC Workflow Monitoring
Controls movement of calibration instruments, verification devices, and maintenance kits across QA labs and clinical engineering units.

Pharmacy-Managed Trial Kit Control
Tracks controlled dispensing kits, investigational supply boxes, and dose-preparation assets across pharmacy-controlled zones.

CRO Logistics Coordination
Supports end-to-end equipment flow between contract research hubs, laboratories, and clinical partner facilities.

Medical Imaging Device Movement
Manages ultrasound probes, portable imaging units, and ancillary diagnostic tools linked to imaging-based endpoints.

Protocol-Specific Device Tracking
Supervises specialized instruments assigned to particular study arms or treatment cohorts to prevent mix-ups.

Wearable Sensor Pool Management
Follows reusable wearable monitoring devices through cleaning, recharging, redeployment, and subject assignment cycles.

Sample Collection Kit Handling
Monitors sample acquisition kits, transport containers, and regulatory-compliant packaging across multi-site collection networks.

Remote Trial Equipment Tracking
Supports decentralized clinical trials by tracking devices shipped to patients’ homes and returned through logistics partners.

Biopharma R&D Device Control
Oversees movement of lab-grade research instruments used in early-phase experimental workflows.

ICF and Documentation Packet Oversight
Tracks sensitive regulatory packets, consent folders, and audit documents during multi-department review cycles.

Surgical Sub-Study Equipment Tracking
Controls specialized surgical tools, sterile processing trays, and procedure-specific kits used in interventional trial arms.

Emergency Response Kit Monitoring
Maintains readiness of crash kits, safety monitoring devices, and emergency-use equipment required under clinical trial risk plans.

Local Server Version of GAO’s Clinical Trial Device Tracking Systems

A local-server deployment supports institutions requiring internal-only data retention, full sovereignty of device telemetry, and strict compliance with regulated research frameworks. GAO provides hardened servers, encrypted storage, and on-premises data processing engines capable of operating in air-gapped or restricted clinical networks. This configuration serves hospital-based studies, biopharma research units, and high-security government trials, aligning with GAO’s long-standing quality assurance investments across North America.

Cloud Integration and Data Management for GAO’s Clinical Trial Device Tracking Systems

Cloud integration enables multi-site device visibility, centralized audit trails, and high-volume dataset management. GAO offers secure APIs, encrypted telemetry channels, and scalable cloud infrastructures that support geospatial tracking, anomaly detection, automated device logs, cross-study dashboards, and regulatory audit preparation. Research sponsors, CROs, and clinical operations leaders can view real-time device locations, utilization metrics, and compliance histories. These capabilities reflect GAO’s four decades of supporting major U.S. and Canadian research institutions, Fortune 500 companies, and government agencies.

GAO Case Studies of Clinical Trial Device Tracking Systems Using BLE or RFID

U.S. Case Studies

• New York City, NY
  A major clinical research center deployed RFID to track investigational devices, sample-collection kits, and calibrated diagnostic tools. GAO configured deterministic read zones using expertise established through decades of R&D in New York City and Toronto.
• Boston, MA
  A biomedical innovation district relied on BLE to monitor mobile medical carts, wearable sensors, and refrigerated diagnostic kits. GAO optimized gateway spacing to support telemetry stability inside dense hospital corridors and lab complexes.
• Philadelphia, PA
  A large academic medical campus used RFID to strengthen chain-of-custody for trial-specific diagnostic tools. GAO calibrated read pathways for controlled dispensing rooms, sterilization workflows, and storage cabinets.
• Chicago, IL
  A metropolitan research hospital adopted BLE to track participant-issued health-monitoring devices and environmental sensors. GAO engineered coverage suited to multi-floor patient wings and complex structural layouts.
• Houston, TX
  A major cancer research facility implemented RFID to oversee the allocation and retrieval of procedural instruments. GAO provided tightly tuned read corridors supporting protocol accuracy and rapid device turnaround.
• Phoenix, AZ
  A regional clinical research network used BLE to supervise movement of wearable biosensor kits across outpatient centers. GAO stabilized signal performance despite wide-area layouts and temperature-sensitive storage needs.
• Los Angeles, CA
  A multi-hospital consortium deployed RFID to manage high-value imaging peripherals and calibration tools. GAO aligned antenna geometry to maintain accuracy across radiology suites and controlled clinical zones.
• San Diego, CA
  A coastal biotech research cluster adopted BLE for tracking portable analyzers and trial kits. GAO refined beacon placement to address interference from specialized laboratory equipment.
• Dallas, TX
  A major medical research institute implemented RFID to maintain custody of sterilized trial instruments. GAO configured read points near prep rooms and controlled-access surgical research areas.
• Atlanta, GA
  A regional clinical network used BLE to monitor device carts, treatment kits, and mobile diagnostic platforms. GAO delivered calibrated telemetry suitable for high-traffic patient care corridors.
• Columbus, OH
  A statewide clinical trial hub relied on RFID to manage distribution and return cycles for controlled medical devices. GAO optimized read accuracy for centralized inventory rooms and outbound logistics points.
• Denver, CO
  A mountain-region medical center adopted BLE to track participant monitoring units and portable study devices. GAO engineered stable telemetry despite structural elevation changes and complex building geometry.
• Miami, FL
  A coastal research hospital implemented RFID to secure proof-of-location for refrigerated sample devices. GAO deployed reader arrays resilient to humidity and equipment-dense laboratory environments.
• Seattle, WA
  A major research institution used BLE to track therapeutic device kits moving between infusion suites, clinical labs, and study storage rooms. GAO designed beacon networks tailored to multi-building research campuses.

Canadian Case Studies

• Toronto, ON
  A major clinical research organization deployed RFID to manage investigational tools and regulated diagnostic devices across controlled storage, calibration labs, and study coordination offices. GAO’s Toronto-based engineering teams ensured precise read calibration.
• Vancouver, BC
  A coastal medical research center relied on BLE to track device carts, biosensor kits, and mobile diagnostic units. GAO configured beacon layouts suited for moisture-heavy environments and complex structural materials.
• Calgary, AB
  A clinical innovation facility used RFID to control custody of sterilized trial instruments and procedural kits. GAO applied quality-assured deployment practices refined over four decades supporting U.S. and Canadian research entities

Our system has been developed and deployed. It is off-the-shelf or can be easily customized according to your needs. If you have any questions, our technical experts can help you.

For any further information on this or any other products of GAO, for an evaluation kit, for a demo, for free samples of tags or beacons, or for partnership with us, please fill out this form or email us.