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EDS Partnership

EDS On-demand

Pooling data and expertise to build SNDS-linked health data warehouses. A virtuous partnership model between data producers and industry players.

70%
of CNIL-approved linked EDS
MR-004
Joint controllership
HDS
Certification
∞
Possible projects
The challenge

A shared need, converging interests

Data producers collect real-world data coveted by industry players. Clinityx facilitates and sustains this virtuous circle.

For data producers

Cooperative groups, learned societies and research centres promote registries and cohorts:

  • Patient, technique or device monitoring
  • Practice evaluation and scientific publications
  • Ongoing search for funding and partnerships
  • Data sovereignty and transparency

For industry players

A growing need for real-world data to answer regulatory questions:

  • Market access
  • HEOR and health-economic evaluations
  • Post-authorisation PASS, PAES or PGR studies
  • Scientific publications and HAS submissions
The model

SNDS-linked EDS under joint data controllership

The partner contributes its data without transferring ownership, its medical expertise and bears the governance of the EDS. Clinityx brings its expertise, the tools required for industrialisation and full investment.

  • Joint data controllership (Co-RT)
  • No regulatory steps required to start studies
  • Integrated MR-004 compliance
  • Sustainable complementary funding source
  • Data sovereignty guaranteed to the producer
  • Scientific committee: no processing without approval
Data producer
Registries, cohorts, learned societies, university hospitals
Joint data controllership
Partner + Clinityx = Co-RT of the EDS
SNDS-linked EDS
Registry data + SNDS Fils probabilistic linkage
Scientific committee
Validation of each reuse project
Industrial or academic partners
RWE studies, publications, HAS submissions
Track record

Linked EDS under joint controllership

70% of SNDS-linked EDS approved by the CNIL are operated by Clinityx.

CardioHub

Cardiology — 7 SFC cohorts ± linked to SNDS.

Colibri

Respiratory — COPD, severe asthma, ILD. 3 cohorts linked to SNDS.

DataMesh

Obstetrics — In partnership with the CHU de Poitiers.

UroCCR

Kidney cancer — French research network. CHU de Bordeaux.
Process

The 3 partnership phases

From the partnership agreement to EDS exploitation, a structured and transparent process.

Phase 1

Partnership agreement

Setting up the data warehouse and contractual framework.

  • Partnership agreement
  • Obtaining CNIL authorisation
  • Setting up the Concepción infrastructure
  • Defining joint data controllership
  • Partner bears governance
Phase 2

EDS implementation

Technical deployment and SNDS linkage, fully handled by Clinityx.

  • Protocol (5 years, annual SNDS renewal)
  • DPIA and eBIOS-RM risk analysis
  • Patient information
  • Data loading (annual renewal)
  • Probabilistic linkage with SNDS Fils
  • Dynamic patient information website
Phase 3

EDS exploitation

Valorisation of data through industrial and academic studies.

  • Contracting with industry players
  • Scientific committee validation
  • Data engineering and data minimisation
  • Hosting and anonymisation control
  • Clinityx manages subcontracting
Governance

Shared and transparent governance

Two complementary bodies ensure scientific quality and operational excellence.

Scientific committee

Guarantor of the scientific integrity of the EDS and research projects.

  • Validation of each reuse project
  • No processing possible without its approval
  • Composed of experts from the partner and Clinityx
  • Supervision of scientific publications

Operational committee

Management of day-to-day operations and data quality.

  • Monitoring of data quality and completeness
  • Planning of annual renewals
  • Coordination of ongoing projects
  • Management of regulatory changes
Exploitation

Responsibility allocation

Clinityx handles the entire technical and regulatory chain, allowing partners to focus on science.

Activity Industrial study Academic study
Protocol writing ✓ —
Regulatory documentation (DPIA & eBIOS-RM) ✓ ✓
PAS drafting — ✓
Data engineering — Data minimisation ✓ ✓
Data transfer to HDH ✓ —
Data science / Analyses ✓ —
Study report / publication writing ✓ —
Project management ✓ ✓
Hosting and anonymisation control ✓ ✓
Publications

Scientific valorisation

A clear framework for scientific recognition of each party's contributions.

Non-commercial research project

For a project led by a non-commercial actor with no commercial use of results:

  • The EDS is cited in scientific publications
  • The partner is cited as author if they participate in the project

Commercial research project

For a project led by a commercial actor:

  • The EDS is cited in scientific publications
  • The partner is cited as author in recognition of their participation in the scientific committee
Infrastructure

Security by design architecture

Clinityx handles the entire technical infrastructure — nothing to internalise on your side.

HDS hosting

Infrastructure certified as a Health Data Host (HDS). Annual audit and validated compliance.

IT security

Segmented environments, eBIOS-RM risk analysis, annual self-accreditation and third-party security audit.

Regulatory compliance

GDPR, CNIL, Sémaphore, Health Data Hub. All regulatory documentation managed by Clinityx.

Data engineering

Ingestion, quality control, SNDS linkage, minimisation and dataset preparation.

Data science

Epidemiology, statistics, health economics. Integrated domain expertise for your studies.

Legal

Standardised contracting, full transparency. The producer cannot and does not want to be a subcontractor for an industry player.

Let's build your EDS partnership

Contact our team to assess the needs, architecture and feasibility of your tailor-made EDS.

Schedule a meeting