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Clinical Study consulting

TEF-Health Service
Consulting
Pricing/Discount Options: Call #2
Unique Identifier: 15c5223f-f4f7-4107-8aeb-a4f374ba9072

Service Description

Overview

Supporting SMEs in the maturation and preparation of their clinical study project for an innovative medical device. The service includes initial discussions with clinical investigation experts to understand the SME’s needs, clarify the clinical objectives, and define the main steps required to prepare and conduct the clinical study. It can include access to expert medical and clinical investigation advice, as well as guidance on the clinical development pathway and identification of relevant funding opportunities. The service is tailored to the maturity of the device and the specific needs of the SME.

How can the service help you?

Providing SMEs with global support in the planning and set-up of their clinical study, tailored to their specific needs and the maturity of their medical device. The service provides guidance on the main steps required to prepare and conduct the clinical study, with access to clinical investigation and medical expertise when needed. It can also include support in identifying relevant partners, expertise, and funding opportunities to facilitate the implementation of the clinical study.

How will the service be delivered?

The service can be delivered remotely, and its duration depends on the SME’s specific needs.

Technical details

The work will be conducted in accordance with

  • 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.

Keywords: clinical study
Service categories: Research & Development Technological Solutions & Documentation Expert Medical Opinion Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Ethics & Regulatory Affairs (ethics board approval, legal requirements, ...) 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

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 Standards
  • Best Clinical Practises
  • EU Regulation 2017/745

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