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Clinical Protocol consulting

Consulting
Pricing/Discount Options: Call #2
Unique Identifier: 09fc104b-6aad-481f-8547-4c2b11a3ee63

Service Description

Support SME to define the clinical investigation methodology (number of subjects, study design, endpoints definition, among others) and to write a first synopsis. It may include: - Access to expert medical opinion. - Budget proposal for the clinical investigation. - Support to funding research; Keywords: Clinical investigation, clinical study;

Offerings: Expert Medical Opinion Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Ethics & Regulatory Affairs (ethics board approval, legal requirements, ...) Development of conformity evaluation standards, protocols & tools 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
Published Email tef-health@chu-grenoble.fr

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 Inputs Technical file of the medical device (intended use, technical specifications, user manual, risk analysis,...)
Service Outputs Clinical protocol synopsis
Service Standards EU Regulation 2017/745 , Best Clinical Practises
  • Best Clinical Practises
  • EU Regulation 2017/745

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