mSafety Digital Biomarker Solution

Technical overview

mSafety Digital Biomarker Solution

Technical overview

A ready-made solution for clinical trials

This biomarker measurement system simplifies remote monitoring, boosts participant adherence and improves results for clinical trials and health research.

Data measurement

The solution collects raw data or augmented data from sensors in the wrist-worn devices. The measured sensor data is transferred to the cloud in real time through a reliable and efficient data transfer process using LTE Cat-M1 technology.

The solution is optimised to operate without the need for frequent user interaction which enables uninterrupted data collection. The collected data is available for processing, analytics or other applications through our cloud service.

Data access

Researchers can view the collected data through the web console. The dashboards in the web console offer a user-friendly and intuitive way of accessing, visualising and interacting with the data, making it an ideal choice for clinicians or study nurses who require regular data access.

Data export and integration

The solution can be used for large-scale data exports. By integrating with external systems through a REST API, you can enable programmatic access to the data and allow researchers to control the data export process. This provides a high level of customisation and flexibility for advanced data processing, or for integration with in-house repositories or external analytic systems. Simple and quick downloads of data samples are also possible.

Data transparency

The mSafety Digital Biomarker Solution separates itself from consumer devices by giving you complete transparency of the collected data. The unfiltered, unprocessed data is entirely yours. Rest assured, Sony does not utilize your data, nor claim any rights to it, making data ownership straightforward.

Trial management

Researchers can set up data collection projects for clinical trials in the solution's user-friendly web console. They can configure the devices and ensure optimal sensor range and frequency for each specific trial. For large-scale trials that involve multiple clinics, researchers can use the data separation feature to manage and monitor data collection across clinics and ensure that the data is collected accurately and securely at every site.

Trial adherence

Researchers can measure the adherence of the trial participant. Sensor data and data about the state of the device (charging, not worn, etc.) are continuously uploaded via the Sony cloud service. This makes it possible to detect when trial participants fail to adhere to trial protocols and lets researchers know when to send reminders or take action. In addition, the device application only displays limited information to the trial participant (time, battery and network status) to remove biases in their adherence.

Device management

The solution supports Firmware Over-The-Air (FOTA) updates, enabling effortless application updates and adjustment of settings with minimal or no intervention. Remotely assign and configure applications, sensors, frequency and range for maximum flexibility.

Diagnostic information from the device – related to network connectivity and battery life – lets researchers identify potential issues and proactively address them. This feature ensures that the devices and data collection remain operational, even in demanding environments.

Device application

The solution features a cellular, wrist-worn wearable device with a device application that is designed for ease of use and performance. The application does not require any accounts, logins, settings, etc. The trial participant does not need to take any actions, except to charge the device.

Device onboarding

The researchers are required to provide trial participants with the wrist-worn device and instruct them to use it. Onboarding the end user is easy, thanks to an intuitive design that requires no input, apart from charging the device. Once the device is on, it transmits data to the cloud server.

Device connectivity

The cellular wearable devices use LTE CAT-M1 (also known as LTE-M or eMTC) which is a low-power wide area (LPWA) network technology designed to support Internet of Things (IoT) devices with an extended battery life. It operates on the same LTE spectrum as existing LTE networks.

Device sensor settings

Device sensors

The integrated state-of-the-art device sensors are designed to meet your technical needs and support a comprehensive remote monitoring experience that unlocks powerful insights. The solution makes it easy to collect precise data from a photoplethysmogram (PPG), a 3-axis accelerometer and a 3-axis gyroscope.

Sensor ranges

The accelerometer supports ranges between ±2g and ±16g. The gyroscope supports ranges between ±125deg/s and ±2000deg/s. Both of the Inertial Measurement Unit (IMU) sensors can individually be set to frequencies from 16Hz up to 128Hz. Frequencies between 16Hz and 32Hz are included in the standard subscription.

Sensor settings

Remote updates let researchers modify sensor settings without collecting the devices physically – adding more flexibility and convenience for seamless data management. Sensors can also be turned off remotely if not needed for the trial, optimising device battery performance and ensuring efficient resource allocation.

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New white paper: Navigate wearables for Decentralised Clinical Trials.

New white paper: Navigate wearables for Decentralised Clinical Trials.