Strengthening One-Stop Clinical Research Support Service from Study Design to Operation and Data Analysis

Tech Doctor Inc. (Headquarters: Chuo-ku, Tokyo; Representative Director: Kazumichi Minato; hereinafter Tech Doctor) has added new features to "SelfBase," its clinical research support service utilizing wearable data.

This update strengthens the participant app's features to help solve practical challenges in wearable clinical research, such as improving research participation retention rates, reducing missing data, and alleviating research operational burden. This app is scheduled to begin use in hundreds of-person scale clinical research projects starting in April 2026.

◾️Expansion of Wearable Clinical Research Utilization and Operational Challenges

In recent years, clinical research utilizing wearable devices such as smartwatches has increased, making continuous acquisition of biological data possible in daily life settings. However, operational challenges have also become apparent, including a decrease in research participation retention rates, missing data, and an increase in the burden of participant support and monitoring tasks.

These challenges not only affect research quality and the reliability of analysis results but also lead to prolonged research periods and increased costs. Therefore, balancing the improvement of the participant experience with operational efficiency is demanded.

◾️Renewal of the SelfBase Participant App

With the aim of improving research participation retention rates and stabilizing data quality, this update reviewed the usability and participation experience of the participant app and expanded its research operation support features.

The main improvements are as follows:

- Added Fitbit linkage function via QR code

Simplifying the device linkage procedure reduces the risk of participant drop-out and smooths the research start-up phase.

- Added ePRO (Electronic Patient-Reported Outcome) function

Participants can easily record their daily symptoms and physical condition via the app, supporting research that combines subjective data with wearable data.

- Enhanced Data Acquisition Status Visualization function

Participants can check the device linkage status, wearing status, and ePRO response status themselves on the app, enabling early response to non-wearing, linkage disconnection, or missed responses. Future plans include the development of a function to send notifications if the data acquisition status falls below a certain threshold. 

This simultaneously reduces the burden on participants and increases the efficiency of research operations, supporting the overall improvement of research quality.

◾️SelfBase Service: One-Stop Support for Clinical Research

SelfBase is a service that consistently supports clinical research utilizing wearable devices, from study design to operation and data analysis.

Specifically, it provides the following support:

- Research theme exploration (utilization of large-scale reference data, prior research investigation)

- Research planning, protocol creation, ethics review application support

- Device selection, procurement, and kitting

- Participant management and data collection

- Data integration, analysis, and model construction

- Report creation and paper submission support

It enables flexible research design combining multiple consumer and research-grade devices, supporting the smooth execution of wearable clinical research at companies and research institutions, and the utilization of data leading to the creation of digital biomarkers. We have been providing the service since 2020 and have a track record of adoption in over 100 research projects.

▼About SelfBase

https://www.technology-doctor.com/selfbase

◾️Benefits of Use

◆ For Research Managers at Pharmaceutical/Food Companies, Academia, etc.

- Increased success rate of clinical research through improved participant retention

- Reduced missing data and stabilized data quality through visualization of data acquisition status

- Realization of patient-centric research through reduced barriers to research participation

◆ For Research Support Managers at CROs, etc.

- Streamlined participant management and monitoring tasks

- Reduced research costs through alleviated operational burden

- Improved research quality through better wearing rate, ePRO response rate, and participation retention rate

◾️White Paper Information

We have published a white paper summarizing domestic and international journal cases that report improvements in research retention rate and data quality in clinical trials where participant apps were introduced.

You can download it here:

◾️Future Development

Going forward, we plan to develop a threshold alert function to quickly identify changes in participants' conditions and a communication function with research participants, as well as expand the range of supported devices. In addition to major consumer devices like Fitbit and Apple Watch, we will sequentially add support for ActiGraph LEAP™ from Ametris, which enables advanced, medical/research-grade data acquisition.

Furthermore, leveraging the analysis technology and research track record we have accumulated, we aim for the further popularization of clinical research utilizing wearable data and the acceleration of social implementation leading to the creation of digital biomarkers.

◾️About Tech Doctor Inc.

Tech Doctor Inc. operates under the vision "Towards an era where data makes us well," promoting the development and social implementation of "Digital Biomarkers," which derive health-related insights from daily sensing data, including from wearable devices. We collaborate with medical, pharmaceutical, food-related companies, and research institutions to realize AI-driven medicine based on data.

Company Name: Tech Doctor Inc.

WEB: https://www.technology-doctor.com/
Date Established: June 21, 2019
Location: Kyobashi Edogrand 4F, 2-2-1 Kyobashi, Chuo-ku, Tokyo
Representative Director: Kazumichi Minato
Representative Physician: Keisuke Izumi
Business Description: Development and operation of the wearable-utilizing clinical research support service "SelfBase," and provision of digital medical solutions

* Digital Biomarker

A digital biomarker is an indicator that continuously and objectively evaluates the presence of disease, changes in symptoms, or the effect of treatment, based on routine biological data acquired from smartphones, wearable devices, etc. A key characteristic of digital biomarkers is that they can continuously acquire "line data" from daily life, whereas traditional biomarkers are "point data" measured temporarily at medical institutions. They are expected to be used for early detection of diseases, monitoring the effectiveness and safety of treatments based on indicators such as exercise, sleep, and heart rate, and even as new endpoints in drug development. Development has been progressing overseas since around 2019, and attention is growing in Japan as well.

* QR Code is a registered trademark of DENSO WAVE INCORPORATED.
* Apple Watch is a trademark of Apple Inc., registered in the U.S. and other countries.
* Fitbit is a trademark of Google LLC.
* ActiGraph LEAP is a trademark of Ametris.