Wearable Biosensor Technology
Medpace is a Leading Core Lab for Wearable Remote Biosensors
Medpace is a Leading Core Lab for Wearable Remote Biosensors
Transforming Clinical Trials with Remote Data Collection
Wearables and other patient-centric portable devices that remotely collect individual biometric data are transforming clinical trials. These devices can be used to evaluate the effectiveness of a medical therapy while delivering many other vital operational and analytic advantages.
Traditional approaches have relied primarily on intermittent assessments of biometric data, usually performed at the trial site. With the development of continuous remote biosensing technologies, wearable devices can support virtual, hybrid, and decentralized trials.
Incorporating New Data Streams While Reducing Costs
Integration of digital biometrics from wearables and remote devices into clinical study data delivers several advantages to patients, sites, and Sponsors. Continuous collection of biosensor data can support digital endpoints and provide a more compelling regulatory case. This approach supports remote electrocardiogram (ECG) recording, ambulatory arrhythmia monitoring, ambulatory blood pressure monitoring (ABPM), continuous glucose monitoring (CGM), self-monitoring of blood glucose (SMBG), and actigraphy.
Data streams from digital biosensors can positively impact study design, patient selection, and go/no-go decisions. A few advantages are:
- Improvement of patient recruitment and compliance: remote biosensors allow for fewer in-person office visits; and provide a way to proactively monitor compliance to improve adherence with trial protocol requirements resulting in reduced protocol deviations.
- Decreased burden on sites and resources: remote biosensors allow for off-site monitoring and analysis on a continuous basis.
- Near real–time health monitoring: remote biosensors provide the site coordinators and investigators the opportunity to proactively monitor the patient’s overall health and receive alerts to adverse events in near real-time.
- Real–world measurements: remote biosensors collect biometric data from patients in the home or work environment during their everyday routine, yielding more representative data about patients’ health and response to treatment.
The Medpace Advantage to Connected Devices
Wearable biosensor technologies selected and vetted by Medpace’s therapeutically-aligned teams meet tailored study design requirements, streamline vendor management, and accelerate study start-up. Medpace seamlessly collects, harmonizes, and integrates data from wearables and remote devices into your clinical study as part of our full-service offering.
Benefits of partnering with Medpace include:
- One-stop shopping with assurance of device selection, logistics, and availability to sites
- Faster and more efficient execution through leveraged relationships and experience with device manufacturers
- Streamlined workflows and systems, incorporating years of collaboration with third party vendors for seamless logistics, operations, and integration
- Technology and expertise to support integration, centralized review and analysis, harmonization, and visualization of study data and management
- Secure data capture and transfer using our indigenously developed, vendor-neutral platform to bridge communication from device to database for faster and direct data ingestion
- ClinTrak Connect, a Medpace-developed mobile application for near real-time data transmission from device to database; customizable for study requirements, including reminders and alerts
- Access to a global team of experts and technologists with strong experience to monitor, analyze, and transform essential biomarker data in support of compliance, data quality, and regulatory review
- Multiple visualization tools enabling near-real time access for stakeholders to review biosensor data and monitor compliance
Medpace Core Lab Integration
Medpace Core Labs provide another level of oversight and analysis for essential biometric data, such as ECG, blood pressure, blood glucose, and actigraphy.
Our integrated core labs provide an end-to-end suite of global imaging, cardiac safety, and metabolic monitoring services to enhance and expedite biopharmaceutical and medical device development. Biosensors produce prodigious amounts of previously untapped health data for clinical studies; Medpace can harmonize collection and integrate this data into the overall study for presentation of strong regulatory cases.
Data Protection
Data from biosensors require up-to-date security infrastructure and controls, data transfer protection, cybersecurity software, firewalls, and data breach and attack simulations (BAS). MCL provides secure systems to manage, report, and visualize remote biosensor data in a format that expedites regulatory review.
Data breach detection and correction ensure data security and regulatory compliance. BAS test security controls the Medpace environment to guard against the latest threats to cyber and data security.
