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Patient-to-Pipeline: Regulatory-Compliant Clinical Data Collection

Physical Consulting Virtual
Unique Identifier: b79e58ca-8fba-4700-97f4-b4490031e371

Service Description

Who Can Benefit: - MedTech & AI Companies: For obtaining high-quality, ethically sourced clinical datasets to fuel algorithm development without navigating hospital bureaucracy. - Clinical Researchers: For systematic, regulation-compliant data collection with full documentation and audit trail.

Key Features: - End-to-end management of ethical approval processes (ethics committee submission, informed consent design) - Prospective data collection within Universitätsklinikum Erlangen clinical departments - Expert clinical annotation and ground truth labeling by domain specialists - Full GDPR compliance with pseudonymization/anonymization pipelines - Structured data output compatible with downstream AI training and analysis workflows

Possible Applications: - Wearable Sensor Studies (e.g. Cardiology): Prospective collection of continuous ECG, PPG, or blood pressure data from cardiac patients for digital biomarker development and remote monitoring algorithm training. - Motion & Gait Analysis (Biomechanics): Systematic acquisition of IMU, force plate, and motion capture data in clinical and sports lab settings for movement disorder assessment, rehabilitation tracking, or athletic performance evaluation. - Neurological Signal Acquisition: Collection of EEG, EMG, or tremor sensor data from neurological patient cohorts to support AI-based diagnostic or therapy monitoring tools. - Real-World Evidence Datasets: Longitudinal data collection from ambulatory patients in everyday settings, enabling the development of algorithms that generalize beyond controlled lab environments. - Athletic Performance & Injury Prevention: Structured data gathering during sports science testing protocols to build datasets for injury risk prediction, load monitoring, and return-to-play decision support. - Multi-Modal Clinical Datasets: Combined collection of sensor data, imaging, lab values, and patient-reported outcomes to enable holistic, multi-modal AI model development.

Who We Are: The Fraunhofer Insitute for Integrated Circuits (Fraunhofer IIS) has established the Center for Sensor Technology and Digital Medicine (CEMDIS) in cooperation with the Universitätsklinikum Erlangen and the Friedrich-Alexander-Universität Erlangen-Nürnberg (FAU) to enhance modern healthcare through innovative sensor technology and digital solutions. This center focuses on integrating innovative medical technologies such as wearables and robotic systems to support medical diagnostics, patient monitoring and evaluating patient-specific therapies by providing digital health solutions für real-life healthcare. Located at the Universitätsklinikum Erlangen, it offers unique infrastructures for the development, integration, and validation of novel health technologies, providing companies opportunities for technological advancements. For more information, visit the Fraunhofer IIS website.

Keywords: wearable sensors medical wearables Data Evaluation Data Acquisition Data handling GDPR Compliance Real-World Data Ethics Approval Clinical Annotation Prospective Data
Offerings: Research & Development Data Processing (curation, preprocessing & standardization, mining, visualization, anonymization, FAIR, etc.) Ethics & Regulatory Affairs (ethics board approval, legal requirements, ...) Data Provisioning (real world and synthetic) Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support, etc.) Testing Facility Real-World (ER, OR, ICU, office, ambulance, ward, patient home, etc.) Testing Laboratory (bioanalysis, wet lab, *-omics, etc.) Clinical Investigation Support (coordination, design, feasibility, documentation,compliance, operations support, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)
Provider Country Germany
Organisation Website https://www.iis.fraunhofer.de/de/ff/sse/health.html
Published Email dhs-studien@iis.fraunhofer.de

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs - Clinical Use Case - Research Question / Hypothesis - Data Modalities / Types of Data - Annotation Requirements - Data Format & Delivery Preferences - Regulatory Context
Service Outputs - Ethics Approval Package and Documentation - Curated & Annotated Clinical Dataset including Metadata - Pseudonymization / Anonymization - Data Storage Option - Data Quality Report
Dependencies & Restrictions - Sponsor of the clinical study has to be the SME: Fraunhofer manages and supports in regulatory affairs in the name of the SME (if desired)
Comments - All data is stored exclusively on internal CEMDIS infrastructure at the highest data security standards – no cloud storage or third-party data processing involved. - The service leverages CEMDIS's physical presence at Universitätsklinikum Erlangen, enabling direct integration into clinical workflows and rapid patient access. - Datasets can be designed to feed directly into AI model training or validation pipelines in corporation with Fraunhofer IIS or HHI. - Experience covers wearable sensor data, physiological signals, motion capture, imaging, and patient-reported outcomes.

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