Skip to Content
← Back to services

DPM-Research: Your Digital Study Office

Consulting Virtual
Unique Identifier: 6bd3ddfc-dde4-4010-88f1-47288a8e8fff

Service Description

Platform: DPM-Research: A customizable eCRF platform that streamlines data and patient management and documentation in clinical studies, aligned with international standards and data protection regulations.

Who Can Benefit: - Clinical Researchers: For streamlined data management processes that support robust research methodologies and regulatory compliance. - Regulatory Compliance Specialists: To ensure that clinical studies adhere to required international and local regulations, minimizing risk and enhancing credibility. - Healthcare Organizations: To manage clinical data effectively, improving research outcomes and operational efficiencies.

Key Features: - Customized Data Management Solution: Provides a tailored data management and documentation platform designed to support clinical research studies. - eCRF Platform: Offers an electronic Case Report Form (eCRF) system customized for collecting and managing clinical research data efficiently. - Compliance with Standards: Ensures all studies are conducted in compliance with ISO 14155 and GDPR (DS-GVO), guaranteeing high standards in clinical investigation and data protection.

Possible Applications: - Clinical Studies: Supports the management of clinical trial and patient data, ensuring accuracy, integrity, and regulatory compliance throughout the research lifecycle. - Data Documentation: Facilitates comprehensive data collection and documentation, improving the reliability and reproducibility of clinical research findings.

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: ISO 14971 clinical datasets quality management system Clinical Investigation ISO 14155:2020 Data Acquisition Data handling GDPR Compliance
Offerings: Software (development, maintenance, deployment, administration, etc.) Clinical Investigation Support Platform (trusted research environment, authentication federation, etc.) Infrastructure (compute, storage, network, HPC, 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
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 - Study Protocol / Study Design: Definition of the clinical study (CIP) - Regulatory Requirements: Specification of applicable standards/regulations - User & Role Concept: Number and roles of study users
Service Outputs - Data Management Plan: fully formulated and regulatory-compliant DMP and Standard Opterating Procedures (SOP) - Configured eCRF Platform: ready for clinical study - Compliant Data Repository: Regulatory-compliant stored study and patient data - Export/Reporting Packages: Structured data exports for analysis & submission - Training Materials & Onboarding: User documentation and initial training for study personnel
Comments - The service can be offered as a full package (setup + hosting + support) or as partial services (e.g., configuration only). - The platform is modular and can be scaled for both single-center and multi-center studies. - Changes to the eCRF after study start (amendments) are possible but are versioned and documented in the audit trail. - Close coordination with clinical study personnel during the design phase is recommended to minimize post-hoc modifications.

Related services

  • 3T MRI Human imaging data acquisition (clinical)

    Centre Hospitalier Universitaire De Rennes (CHU RENNES)

    MRI 3 Tesla (Philips Ingenia Edition X), imaging, data acquisition, clinical

    View service →
  • 3T MRI Imaging data acquisition (Clinical)

    Karolinska Institutet (KI)

    Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility, MRI Centre, aims to catalyse novel and translational research using MRI. We offer a state-of-the-art 3 Tesla GE SIGNA Premier system-wide bore gantry and high-performance XT gradients. We support all types of MRI studies in humans, ranging from small single-centre projects to large-scale international multi-centre studies. A special focus is on offering MRI suitable for multi-modal integration such as CT, PET, EEG and MEG. The KI MRI Centre also offers a full-service lab for drawing blood and investigating psychophysiology (EDA, PPG, Eye-tracking) along with standardised image post-processing and data storage facilities with cluster computing for data analysis. In this service, we offer full support in project consultation, ethical permits and module technical support. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/mrc

    View service →
  • 3T MRI Imaging data acquisition (Pre-clinical, Large animal)

    Karolinska Institutet (KI)

    Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facilities, Karolinska Experimental Research and Imaging Centre (KERIC) and the MRI Centre, aim to catalyse novel and translatory research using MRI. At KERIC, we offer a 9.4T MRI for animals such as rabbits and small piglets (see service for small animal 9.4T MRI). A state-of-the-art 3 Tesla GE SIGNA Premier system-wide bore gantry and high-performance XT gradients are available for large animal preclinical studies. We offer specialised services for large animal models as well as ex vivo imaging and support all types of MRI studies in humans, ranging from small single-centre projects to large-scale international multi-centre studies. A special focus is on offering MRI suitable for multi-modal integration such as CT, PET, EEG and MEG. The KI MRI Centre also offers a full-service lab for drawing blood and investigating psychophysiology (EDA, PPG, Eye-tracking) along with standardised image post-processing and data storage facilities with cluster computing for data analysis. In this service, we offer full support in project consultation, ethical permits, module technical support and animal technicians. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/mrc Or https://imagingresearch.se/facilities/corefacilities/keric

    View service →
  • 7T MRI Imaging data acquisition (Clinical)

    Karolinska Institutet (KI)

    Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility, MRI Centre, aims to catalyse novel and translational research using MRI. A unique next-generation clinical 7 Tesla Siemens MAGNETOM Terra.X. equipped with an ultra-high field scanner also offers cutting-edge gradient performance (130 mT/m at 250 T/m/s), parallel transmission, as well as deep learning-based acceleration and denoising for improved image quality. Micrometre resolution in vivo for microstructural imaging and layered fMRI. We support all types of MRI studies in humans, ranging from small single-centre projects to large-scale international multi-centre studies. A special focus is on offering MRI suitable for multi-modal integration such as CT, PET, EEG and MEG. The KI MRI Centre also offers a full-service lab for drawing blood and investigating psychophysiology (EDA, PPG, Eye-tracking) along with standardised image post-processing and data storage facilities with cluster computing for data analysis. In this service, we offer full support in project consultation, ethical permits and module technical support. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/mrc

    View service →
  • 9.4T MRI Imaging data acquisition (Pre-clinical, Small animal )

    Karolinska Institutet (KI)

    Centre for Imaging Research (CIR) is a world-leading imaging centre at Karolinska Institutet in Sweden in collaboration with SciLIfeLab and RISE. It offers an exceptional and unique collection of core facilities for cutting-edge structural, functional, and metabolic in vivo multimodal imaging and endovascular/minimally invasive surgical techniques. The core facility Karolinska Experimental Research and Imaging Centre (KERIC), we have a preclinical 9.4T Bruker USR 94/30 MRI system. The state-of-the-art 9.4T MRI is equipped with single-mouse, single-rat, or double-mouse beds. It has three gradient bore sizes to arrange an effective inner diameter of 20cm (large animals), 12cm (medium animals) or 6cm (small animals). Methods in anatomical imaging, fMRI, Ex vivo, Pharmacological MRI and Cardiac imaging (CINE). For the mouse brain, a 4-channel phased array cry-coil drastically increased signal-to-noise. In this service, we offer full support in project consultation, ethical permits, module technical support, animal technicians and data analysis. We can host animals directly or indirectly through collaboration within KU (AKM) and other animal labs. For more information, visit the website: https://imagingresearch.se/facilities/corefacilities/keric

    View service →
  • Access to Compound Collection

    Karolinska Institutet (KI)

    The Unit: Chemical Biology Consortium Sweden (https://www.scilifelab.se/units/cbcs/) The infrastructure is part of Science for Life Laboratory (SciLifeLab) which is an academic collaboration between Swedish universities (including Karolinska Institutet) and a national research infrastructure with a focus on life science. Chemical Biology Consortium Sweden (CBCS) is a national research infrastructure offering an extensive portfolio of services - from computational and organic chemistry to phenotypic small molecule screens in cells and model organisms, cell painting and functional precision medicine. The mission of CBCS is to provide a state-of-the-art platform and expertise for the generation of high-quality bioactive chemical tools (small organic molecules) for applications within life science research in general and with the ultimate goal to explore complex biology. Our units comprise compound handling labs (hosting the SciLifeLab Compound Collection of ca 350,000 molecules), screening labs (microtiter format liquid handling robotics and a wide range of plate readers), and chemistry labs (equipment and instrumentation for organic chemistry synthesis and analysis). The service: Access to compound collection https://www.cbcs.se/the-compound-collection The Scilifelab Compound Collection is managed by the Compound Center at CBCS KI, and is based on donations of high-quality sets from the pharmaceutical industry (Biovitrum, Karobio, Orexo/Biolipox, KDev) and has been developed and expanded with compounds from various commercial compound vendors. The compounds can be readily available in assay-ready plates through acoustic nano-litre scale liquid dispensing or in 96-tube racks; compounds are stored at 10mM concentration in DMSO solution at - 20 °C under humidity control. We provide: o Management, storage, and processing of solids and liquids. o Compound delivery and interface with key customers. o Performance of instruments and automation that support these operations. o Analytical techniques used for quality assurance. o Sample informatics, including registration and compound quality data.

    View service →