Digital Biomarkers

Clinical ink's Digital Biomarkers platform is a best-in-class analytics solution designed for sponsors, researchers, and clinical trial teams seeking to capture, collect, and interpret real-time patient data. By leveraging digital devices such as smartphones, wearables, and sensors, the platform enables objective, continuous measurement of patients' physiology, behavior, and disease progression to support the evaluation and development of new treatments.

Digital biomarkers are objective, quantifiable physiological and behavioral data points collected from digital devices. Unlike traditional clinical trial endpoints measured during specific clinic visits, digital biomarkers provide continuous, real-time information that offers a more comprehensive view of a patient's health over time. Clinical ink's team of scientists, architects, data engineers, data scientists, and software engineers are actively advancing this technology to power patient-centric clinical research.

Measuring Patient Response

• Use any digital device to measure a patient's biological response in real-time
• Improve patient engagement and compliance throughout the trial
• Visualize data in dashboards to monitor patient adherence and data quality
• Build machine learning solutions to improve patient-centric insights into behavior and compliance
• Perform root cause analysis to understand patient behavior in bring-your-own-device (BYOD) studies

Data Quality and Decision Support

• Validate measurements derived from sensors, algorithms, and clinical data in real-time
• Fuse data sources from multiple sensors into a common reference frame
• Ingest data into enterprise data lake solutions for expedited analysis
• Conduct real-time quality control checks on all incoming data sources

Developing Disease-Specific Digital Biomarkers

• Evaluate sensor data streams to identify optimal solutions for capturing disease-relevant signals
• Engineer features using time- and frequency-dependent signal processing routines and algorithms
• Construct multivariate modeling methods to evaluate mixed effects in complex study designs

Types of Digital Biomarkers Supported

• Physiological metrics such as heart rate
• Behavioral indicators such as activity levels
• Patient-reported outcomes
• Specialized health indicators relevant to diverse clinical research solutions

Key Benefits of Digital Biomarkers in Clinical Trials

• Real-Time Monitoring: Enables continuous tracking of patients' health, providing timely insights and supporting adaptive interventions
• Enhanced Data Quality: Objective, high-quality data minimizes human error and supports more robust analyses
• Patient-Centric Approach: Remote monitoring and participation makes trials more accessible and comfortable for patients
• Cost-Effective Solutions: Often more economical than traditional methods, facilitating broader and more diverse trials
• Support for Decentralized Trials: Aligns with modern decentralized trial approaches, promoting flexibility and innovation in trial design
• Improved Recruitment and Retention: Remote participation reduces the need for frequent clinic visits, attracting and retaining more participants

Disease Area Focus

• Clinical ink has published research on digital biomarkers as endpoints in Parkinson's Disease (PD), exploring novel digital assessments being developed to validate biomarkers and their application in clinical trials

The Clinical ink platform supports the incorporation of Digital Health Technologies (DHTs)—including sensors and wearables—into clinical trials, ensuring the highest standards of data collection, transmission, security, quality, and analysis. Mobile assessments are engineered by experienced clinical, software, data, and user experience experts, enabling patient-centric research at scale across a wide range of therapeutic areas and study designs.