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Clinical Research Services: medical writing

Physical
Pricing/Discount Options: Call #2
Unique Identifier: af2fc604-f5b4-47d6-a7fa-7edb9d3f8c72

Service Description

Writing the documentation dedicated to the clinical investigation and needed for the regulatory submission: protocol, patient information letter; support to the technical file writing (including the investigator brochure) under the manufacturer responsability.

Offerings: Ethics & Regulatory Affairs (ethics board approval, legal requirements, ...) 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 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 Study methodology is defined; Budget is defined
Service Outputs Authorized protocol; Patient information letter
Service Standards EU Regulation 2017/745; Good Clinical Practise; European Clinical Research Infrastructure Network (ECRIN) label
  • EU Regulation 2017/745
  • European Clinical Research Infrastructure Network (ECRIN) label
  • Good Clinical Practise

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