Skip to Content

Data Services n°1 - SME Initial Consulting

Virtual
Pricing/Discount Options: Call #2
Unique Identifier: a98fcc5c-8b14-4376-b05a-edcf348a1957

Service Description

This service aims to formalise and consolidate the SME's request (thanks to our expertise in clinical data warehouse and clinical investigation) and to specify services that we provide which will allow to conduct the study. Eventually, complementary services provided by other partners can be identified. This service includes a consultation session of approximately 2 hours to discuss the proposed project, its key aspects, its direction, and its feasibility. We will leverage our expertise in the reuse of real-world health data, addressing aspects such as data availability, feasibility, regulatory processes, and study methodologies.​

Method Description: The service includes : - Contact form - Documentation of the requirement - Specification document - Identification of the Medical Service Rendered - Identification of inclusion factors, epidemiological factors, factors linked to objectives, confounding factors - Scope : CDWH/CDWH network/SNDS/ academic labs or other TEF partners - Choice/identification of the project manager/sponsor

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 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