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Data Services n°3 - Methodological Advising

Virtual
Unique Identifier: 5005b235-ed53-4276-a0a0-ac7b6e128edf

Service Description

This support service offer to companies scientific and methodological advice throughout the project. It includes regular progress meetings and ongoing support from a project manager. This may also include support in drafting the research plan and contacts with healthcare professionals. This service provides comprehensive support for companies' R&D projects, with personalized follow-up tailored to their needs, while ensuring the clinical validity of their approaches to exploit clinical warehouse data.​

Details :​ - Meeting with a Clinical Research Project Manager from the Clinical Data Center. The project manager will ensure project management in our institution and key steps related to clinical data warehouse exploitation (e.g., submission to local ethics and scientific commitee).​ - Regular meetings including a group of experts specialized in medicine, clinical data science, clinical research and health technology. Pricing will depend on the mobilized expertise and regularity of the meetings.​ - The opportunity to have your research protocol reviewed and evaluated by experts. This service includes one submission. New submission will result in a re-evaluation of the service charges.​

Prerequisite : our service Feasibilty study must have been previously conducted.​

Method Description: The service includes a minimal mandatory task set. Optional tasks can be jointly selected depending on the SME needs and available resources: - Regular progress meetings (fortnightly/monthly) [mandatory] - Review and advice on research plan writing, testing and evaluation [optional] - Review and analysis of research plan by clinicians [optional]

Method reference: Local method respecting General Data Protection Regulation (GDPR), EU regulations 2017/745 and 2020/561 on medical devices, AI Act and Good Clinical Practice (GCP)

Offerings: Research & Development Quality Management Business (market readiness, monitoring, feasibility, etc.) Expert Medical Opinion
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 Standards General Data Protection Regulation (GDPR) Good Clinical Practice (GCP) EU regulations 2017/745 and 2020/561 on medical devices AI Act
  • AI Act
  • EU regulations 2017/745 and 2020/561 on medical devices
  • GCP
  • GDPR

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