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Clinical Research Unit 5- Regulatory support

TEF-Health Service
Physical Consulting
Pricing/Discount Options: Call #2
Unique Identifier: 4d645587-db92-4ab3-954b-db0c6c36e1ca

Service Description

Overview

Supporting SMEs with the submission of the clinical investigation documentation to the relevant French regulatory authorities, including the Ethics Committee (CPP) and the ANSM (if needed). The service also includes follow-up of the submission and management of feedback or requests for additional information from the CPP and ANSM, in coordination with the SME.

How can the service help you?

The service helps SMEs navigate and manage the submission process with the French regulatory authorities, ensuring that the required documentation is submitted through the appropriate channels. It also provides support in managing regulatory feedback and requests for additional information, helping the SME respond efficiently and avoid unnecessary delays in the clinical investigation approval process.

How will the service be delivered?

The service can be delivered remotely.

Technical details

First, we will verify that all the documentation required for the clinical investigation is complete and available (Clinical Investigation Plan, Informed Consent, Investigator’s Brochure, insurance, etc.). We will then proceed with the submission in accordance with the applicable procedures. If the submission is not approved at the first review by the French Ethics Committee (CPP), we will prepare responses to the committee's comments and implement the necessary amendments in close collaboration with the company prior to resubmission.

Service customization

A clinical investigation plan has to be validated. All documentation required for the submission must be finalized.

Keywords: ethical committee ansm
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 2000–6000 EUR
Reduced Price 1500–5000 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 All regulatory documentation required for the clinical study
Service Outputs Clinical study approved by the Ethics Committee (CPP) and the ANSM (if needed)
Service Standards
  • EU Regulation 2017/745
  • Good Clinical Practices

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