Skip to Content
← Back to services

Clinical Research Unit 2- Methodology and budget proposal

TEF-Health Service
Physical Consulting
Pricing/Discount Options: Call #2
Unique Identifier: f79c634e-2205-47e7-a2e2-ff89f3724192

Service Description

Overview

Supporting SMEs in the design and preparation of their clinical investigation, from the definition of the study objectives and methodology to the development of a clinical investigation synopsis. The service includes an assessment of the company’s needs and recommendations tailored to the maturity and characteristics of the medical device. The service covers the identification and access to relevant medical expertise, as well as the identification and coordination of the multidisciplinary professionals required for the project, including internal partners and external providers. Support is provided in defining the clinical investigation methodology, including study design, target population, number of subjects, endpoints, and other key methodological aspects. A preliminary budget proposal for the whole clinical investigation can also be provided, together with support in identifying potential funding opportunities and preparing funding applications.

How can the service help you?

The service helps SMEs translate their clinical needs into a well-defined, feasible, and scientifically sound clinical investigation project. It provides access to relevant medical and multidisciplinary expertise, supports the definition of the study methodology and key parameters, and helps anticipate the resources, costs, and funding opportunities associated with the clinical investigation.

How will the service be delivered?

The service can be delivered remotely through meetings with the appropriate experts. Healthcare professional from CHUGA must be involved.

Technical details

The work will be conducted in accordance with the ICH Guideline for Good Clinical Practice (GCP) E6(R3), EU regulation MDR 2017/745 and the ISO 14155:2026 standard.

Service customization

Tasks are tailored to the SME’s specific needs.

Keywords: budget proposal clinical study methodology
Service categories: Testing Clinical (investigation, trial, etc.) Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support, etc.)
TEF-Health Use Case Domain: all
Provider Logo

Provider & Contact

Provider Organisation Centre Hospitalier Universitaire De Grenoble (CHUGA)
Provider Country France
Ask about this service
Billing: per project
Full Price 8000–10000 EUR
Reduced Price 6500–8500 EUR
Pricing Detail

Prices are subject to change and are indicative only. The final price will be determined by a quote based on SME's needs, and it wil be validated by the contract between the service provider and the applicant.

Operational Details

Service Outputs Clinical synopsis
Service Standards
  • EU Regulation 2017/745
  • Good Clinical Practices
  • ISO 14155

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 →