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Clinical Research Unit 6- Clinical operations set-up and coordination

TEF-Health Service
Physical Consulting
Pricing/Discount Options: Call #2
Unique Identifier: d4011141-6785-4f30-8925-b48a9f19fef8

Service Description

Overview

Supporting SMEs in the operational set-up and coordination of their clinical investigation, from site initiation visit through patient inclusion, follow-up, and data collection. The service covers patient recruitment and inclusion, coordination of clinical sites, patient follow-up, data collection and management, study committee organization (scientific, safety, adjudication…), query management, and coordination of the different stakeholders involved in the study. The clinical investigation can be conducted in a single-centre or multi-centre setting, with CHUGA acting either as the sponsor or as an associated investigation site, depending on the project. The service can be tailored to the specific operational requirements and complexity of the clinical investigation.

How can the service help you?

The service helps SMEs set up and efficiently run the operational aspects of their clinical investigation, from patient inclusion to data collection and follow-up. It provides access to experienced clinical teams and established hospital infrastructure, facilitating coordination between the different stakeholders and supporting the smooth conduct of the study.

How will the service be delivered?

The service can be delivered either at CHUGA clinical sites or at other clinical sites.

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
  • ISO 14155:2026 standard

Service customization

Tasks are tailored to the SME’s specific needs. The clinical protocol must have been finalized and approved by the relevant national regulatory authorities and the Ethics Committee.

Keywords: site initiation visit clinical study coordination
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
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Provider & Contact

Provider Organisation Centre Hospitalier Universitaire De Grenoble (CHUGA)
Provider Country France
Ask about this service
Billing: per hour
Full Price 55–135 EUR
Reduced Price 45–135 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 Inputs Clinical protocol approved by regulatory authorities (Ethical committee, ANSM)
Service Outputs Clinical study conducted under effective oversight
Service Standards
  • EU Regulation 2017/745
  • Good Clinical Practices
  • ISO 14155

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