Skip to Content
← Back to services

Clinical Research Services - Medical writing

TEF-Health Service
Physical Consulting
Unique Identifier: c0091fe5-4ab7-466c-84cf-ea95f111cc17

Service Description

OVERVIEW : This service consists in the preparation, the review, and the management of clinical, scientific, and regulatory documents required for the planning, conduct, reporting, and publication of clinical investigations, ensuring clarity, accuracy, and compliance with applicable regulatory requirements and investigation specific needs. This service includes the provision of regulatory submission documents: Clinical Investigation Plan (CIP), Patient Information and Consent documents (ICF), Clinical trial Agreement (CTA), ”Demande d’Avis au Comité d’Ethique” (DACE), etc.; of the Investigator Site File (ISF) containing investigation essential documents and of the Trial Master File (sponsor’s investigation documents).

HOW CAN THE SERVICE HELP YOU ? : The service provides the SME with access to specialized medical, regulatory, and scientific expertises for the preparation of documentation required for clinical investigations and regulatory submissions. It ensures that documents are scientifically sound, consistent, and aligned with applicable regulatory requirements, while reducing the workload associated with their preparation and review.

HOW WILL THE SERVICE BE DELIVERED ? : The service is delivered by HUmani’s Clinical Research Unit through various meetings (face-to-face or remote) with the customer, and the other relevant stakeholders where needed.

PROVIDER DESCRIPTION : HUmani CHU Charleroi-Chimay is a hospital network composed of five general and specialized hospitals and 8 polyclinics offering healthcare services in more than fifty medical and surgical specialties. Located in Belgium, at the heart of Europe, we are strongly committed to clinical research with the support of a dedicated Clinical Research Unit offering Clinical Research Organization (CRO)-like services.

TECHNICAL DETAILS : This service is performed in compliance with international guidelines for Good Clinical Practice (ICH-GCP E6 R3), MDCG 2024-3, MDCG 2024-5, the ISO 14155:2026 standard; EU regulations 2017/745 (MDR), 2016/679 (RGPD), and Belgian laws and Royal Decrees.

SERVICE CUSTOMIZATION : This service is tailored to the specific needs of the SME and the clinical investigation, and might be delivered by HUmani either as part of its role as the full sponsor of your investigation, or on an “à la carte” basis.

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 HUMANI SC - Hospital network (HUMANI)
Provider Country Belgium
Ask about this service
Billing: per hour
Full Price 76–90 EUR
Reduced Price 54–202 EUR

Operational Details

Service Inputs Medical device documentation; Feasability report; Preliminary synopis; Project draft; Clinical investigation protocol
Service Outputs Essential documents : clinical investigation protocol; informed consent form; Logs; etc; Clinical investigation files (site master file; investigation sponsor file); clinical investigation agreement draft
Dependencies & Restrictions  
Certification Support  
Service Standards
  • Artificial Intelligence Act
  • Belgian national laws
  • EU regulations: Medical Devices
  • GDPR
  • IATA
  • International regulations: Good Clinical Practice (ICH-GCP)
Comments  

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 →