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Clinical Research Services: clinical operations monitoring

Physical
Pricing/Discount Options: Call #2
Unique Identifier: 8d712a54-72f8-41fb-8190-0cbca7a7946e

Service Description

Clinical sponsoring/monitoring/vigilance; performing all sponsoring/monitoring/vigilance activities ensuring compliance to the clinical investigation plan and regulatory requirements.

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 The clinical protocol has been authorized by the French national regulatory authorities (Ethical committee and/ or ANSM and/ or CNIL). The project mangement plan has been written
Service Outputs Last patient, last visit; Clean database
Dependencies & Restrictions Authorized protocol
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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