Medidata Sensors

Medidata Sensors is a clinical trial data capture platform designed for sponsors, sites, and partners who need to go beyond periodic clinic visits to understand patient health. By enabling continuous, medical-grade wearable data collection, the platform combines objective digital measures with electronic Clinical Outcome Assessments (eCOA) to build a comprehensive picture of how patients feel, function, and respond to treatment over time — without increasing participation burden.

The platform is purpose-built to transform continuous sensor data into endpoint-ready evidence. Rather than generating raw signals, Medidata Sensors applies validated algorithms to objective and subjective data within the same study context, supporting digital endpoints that can be evaluated with greater confidence as the trial progresses.

Supported Physiological and Functional Measures

• Vital signs, cardiac, and respiratory monitoring
• Metabolic and electrodermal activity measurement
• Sleep, snoring, and cough tracking
• Scratch detection and falls monitoring
• Activity, mobility, and physical functioning assessment
• Involuntary movement and upper limb mobility capture
• Both episodic and continuous data collection modes supported
• Over 85 validated sensor measures and algorithms
• FDA-cleared 510(k) sensors for targeted therapeutic areas

Key Platform Capabilities

• Unified data environment: Objective sensor data and subjective eCOA data are collected and analysed together, giving clinicians and study managers complete patient views and meaningful trends in a single platform.
• Validated algorithms: Rigorously tested algorithms generate evidence as the study progresses, enabling earlier visibility into emerging issues and reducing late-stage surprises.
• Endpoint confidence: Combining digital measures with patient-reported outcomes allows sponsors to surface meaningful change earlier and evaluate digital endpoints with greater confidence during the trial.
• Shared clinical context: Study teams across roles benefit from a shared view of patient data, supporting coordinated decision-making throughout the trial.
• Trial-grade sensor integrations: Integrations are rigorously tested and feature secure data flows appropriate for regulated clinical trial environments.

Reducing Patient and Operational Burden

• Passive and at-home data collection options minimise the need for clinic visits.
• Patients can capture sensor data directly through the intuitive myMedidata mobile app in an unobtrusive manner.
• Complex assessments such as the six-minute walk test can be completed by patients from home, as demonstrated in a real-world at-home functional capacity assessment use case generating trial-ready cardiac and motion data.
• Low-code and no-code sensor study configuration is available through Medidata Designer, reducing operational complexity for sponsors.
• Clear sensor instructions and dashboard tools for patient management are included to streamline study setup and execution.

Training and Support

• Medidata offers a range of training options for clients and partners, including self-paced and instructor-led courses.
• Training resources are accessible through the Medidata Global Education and Training section.

Medidata Sensors is part of the broader Medidata Platform, which encompasses patient, data, and study experiences alongside professional services. The solution is designed for regulated clinical trials, utilising FDA-cleared devices and trial-grade integrations with secure data flows to meet the rigorous standards required for evidence generation in drug development.