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Clinical Protocol consulting

Consulting
Pricing/Discount Options: Call #2
Unique Identifier: a30e6a17-2218-449c-9f1c-d2dd4a19bce1

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: Identification & access to medical & other experts advice; Support to get funding research.

Keywords: Clinical investigation, clinical study, methodology, synopsis, funding

Offerings: Research & Development Ethics & Regulatory Affairs Expert Medical Opinion Conformity & Compliance (certification, audit, corrective and preventive action, documentation, gap & risk analysis, etc.) Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support) Development of conformity evaluation standards, protocols & tools
TEF-Health Use Case Domain: All
Provider Logo

Provider & Contact

Provider Organisation Centre Hospitalier Universitaire De Rennes (CHU RENNES)
Provider Country France
Published Email tef-health@chu-rennes.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
Dependencies & Restrictions Validation of the project by a clinician; NDA
Service Standards EU Regulation 2017/745 Good Clinical Practise
  • EU Regulation 2017/745
  • Good Clinical Practise

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