From Study Design to Scientific Evidence

We support the evaluation and validation of a broad spectrum of healthcare technologies, including wearables, medical devices, digital health applications, sensor-based systems, AI-supported analytics solutions, and technologies for acquiring physiological and movement-related data.

Together with our partners, we design study concepts tailored to specific research questions and use cases, enabling the scientific assessment of performance, usability, and clinical relevance.

We offer a wide range of study formats, from exploratory pilot and feasibility studies to technical validation studies, clinical investigations, and other clinical studies. Together with our partners, we develop tailored study designs that provide reliable scientific evidence for research, product development, and regulatory approval.

Subject studies are particularly valuable when new technologies need to be evaluated with human participants under controlled or real-world conditions. Typical use cases include assessing the performance of wearables, investigating user acceptance of digital health applications, validating sensor technologies, or studying physiological and cognitive processes.

The resulting data provide valuable insights for research, product development, and regulatory activities.

Yes. We support companies and research institutions in conducting GCP-compliant clinical studies and other clinical investigations involving the German Federal Institute for Drugs and Medical Devices (BfArM), excluding pharmaceutical trials. Our services include proof-of-concept studies, clinical validation studies, and clinical investigations for medical device approval.

All studies are conducted in accordance with the relevant regulatory requirements and, where necessary, in close collaboration with the responsible authorities and project partners.

Yes. Successful studies begin long before data collection starts. Together with our partners, we develop study concepts that balance scientific objectives, regulatory requirements, and practical considerations.

This includes defining appropriate endpoints, selecting suitable measurement methods and modalities, determining participant numbers, and preparing study protocols. Our goal is to create study designs that generate meaningful data while remaining feasible to implement.

By identifying development risks early, avoiding unnecessary iterations, and establishing the basis for robust evidence, a well-designed study can significantly increase the value of the results.

Depending on the research question, we collect a wide range of physiological, movement-related, and subjective data.

The following acquisition modalities are currently available:

• Image-based HRV (heart rate variability): Heart rate variability derived from imaging
• ECG (electrocardiography): Measurement of the heart's electrical activity
• HRV with ECG
• EGG (electrogastrography): Monitoring of gastric and intestinal activity
• EMG (electromyography): Assessment of muscle activity
• PPG (photoplethysmography): Optical measurement of pulse rate
• EDA (electrodermal activity): Measurement of skin conductance, which typically increases under stress
• Skin temperature
• EEG (electroencephalography): Measurement of the brain's electrical activity
• Respiration monitoring

These modalities can be complemented by carefully designed questionnaires that allow subjective experiences to be compared with objectively recorded physiological and emotional responses.

Can't find the modality you need? We maintain an extensive network of scientific partners and can integrate additional measurement modalities depending on your specific requirements.

Every research question is unique. That is why we provide flexible support throughout the entire study process, from the initial idea and study design to data acquisition, analysis, and interpretation of the results.

Depending on your requirements, we can take responsibility for individual work packages or support the complete evaluation process.

Yes. In addition to study planning and execution, we support the analysis and interpretation of collected data. To do so, we apply advanced methods in data fusion, signal processing, statistics, and artificial intelligence.

By combining and analyzing data from multiple sources, complex relationships can be uncovered and meaningful insights generated for research, product development, and clinical applications.

Interested in learning more? Explore our approaches to AI-based analysis of medical data.