Hepatology / Gastroenterology services

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Clinical investigation set-up of the with patient inclusion, patient follow-up, data collection, queries management, ... • Clinical investigation coordination (mono-centric or multi-centric). • The IHU may be the sponsor or an associated investigation center.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Submission to the French regulatory authorities (Ethical committee CPP, ANSM). • Feedback management with these regulatory authorities to take into account their requirements.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

eCRF, DMP, DVP

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Discussion of the SME needs and suggestions. • Technical feasibility according the medical device maturity

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Writing the documentation dedicated to the clinical investigation and needed for the regulatory submission: protocol, patient information letter. Support to the technical file writing (including the investigator brochure) under the manufacturer responsability.

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Definition of the SME needs and suggestions. • Access to expert medical opinion. • Definition of the clinical investigation methodology (number of subjects, study design, endpoints definition...) • Budget proposal for the clinical investigation. Support to funding research

Fondation De Cooperation Scientifique (IHU STRASBOURG)

• Assisting SMEs in regulatory submissions in compliance with applicable laws and requirements • Providing SMEs with the necessary regulatory documents • Liaison with regulatory bodies: Ethics Committees (EC), National Agency of Drugs Safety (ANSM)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Journals, Meetings, Events

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Rental of the simulated OR and the image acquisition devices : Artis Zeego (pricing doesn't include human resources that must be present in support)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Rental of the simulated OR and the image acquisition devices : CT SCAN (pricing doesn't include human resources that must be present in support)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Rental of the simulated OR and the image acquisition devices : MRI (pricing doesn't include human resources that must be present in support)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Rental of the simulated OR and the image acquisition devices : US, (pricing doesn't include human resources that must be present in support)

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Test and validtation by users in simulated or real OR environment of your medical device

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Clinical acquisition of images in an OR using different imaging modality : -US -EUS -Endoscopy -MRI -CT SCAN -Artis Pheno *Clinical data collection must be included in a clinical study that IHU can design according to your needs*

Fondation De Cooperation Scientifique (IHU STRASBOURG)

Preclinical acquisition of images in an OR using different imaging modality : -US -EUS -Endoscopy -MRI -CT SCAN -Artis Zeego *Preclinical data collection must be included in a preclinical study that IHU can design according to your needs*

Fraunhofer Gesellschaft Zur Forderung Der Angewandten Forschung Ev (Fraunhofer)

**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](https://www.iis.fraunhofer.de/de/ff/sse/health/zentrum-sensorik-medizin.html).

Fondation De Cooperation Scientifique (IHU STRASBOURG)

8 clinical Operating Rooms 5 simulated Operating Rooms (preclinical)