Data sourcing is where the majority of RWE programme delays originate. A study design can be completed in four to six weeks. Getting legally compliant, analysis-ready data from a European national claims database or hospital network commonly takes three to six months – longer if the sponsor has no prior relationship with the data holder, if the governance framework has not been designed in advance, or if the data access request does not conform to the data holder's submission requirements.

For sponsors whose RWE timelines are critical – supporting a regulatory submission, a market access dossier, or an early benefit assessment under a specific payer timeline – data sourcing delays are programme risk.

APICES has existing access relationships with major European real-world data holders across France, Germany, Spain, Italy, the Netherlands, and the UK, built through Kappa Santé's 25-year history in European RWE. These relationships reduce the time from study initiation to data-ready by three to six months compared to a cold approach, and provide knowledge of each data holder's governance requirements and data format specifications that is not available from a data catalogue.

European Real-World Data Sources

• France: SNDS (Système National des Données de Santé) – the primary French claims and hospital database covering the entire reimbursed population
• Germany: GKV claims networks, disease-specific registries, and prescriptions data panels
• Spain: BIG-PAC (Valencia Linked Healthcare Database), CMBD hospital discharge data, and primary-care records networks
• Italy: Italian Regional Health Information Systems (ARNO, HSD, Valore), cancer registry networks
• Netherlands: PHARMO Database Network, NIVEL Primary Care Database, and hospital-linked records
• United Kingdom: CPRD (Clinical Practice Research Datalink) Aurum and GOLD, Hospital Episode Statistics (HES)
• Pan-European: DARWIN EU partner data network for pharmacovigilance studies; OMOP CDM-standardised environments for federated analyses

Data Governance Under GDPR and European Data Protection Frameworks

Every real-world data study involving personal data must comply with GDPR (Regulation (EU) 2016/679) and applicable national data protection law. For health data, additional restrictions under GDPR Article 9 apply.

• Data Protection Impact Assessment (DPIA) preparation and review under GDPR Article 35
• Legitimate basis for health data processing: Article 9.2(i) for scientific research, Article 9.2(j) for public interest research
• Data processing agreements and data transfer agreements with data holders in each jurisdiction
• Data minimisation and pseudonymisation requirements specific to the data source and study design
• Information governance approval processes at hospital or regional health authority level
• Documentation of data flows, retention periods, and access controls in the data management plan

Data Source Suitability Assessment

Before recommending a data source, APICES performs a suitability assessment addressing: whether the patient population is represented at sufficient scale; whether key exposure and outcome variables are available at the required granularity; data quality in the relevant time period; access timelines, governance requirements, and cost structure; and known limitations for the proposed study design.

This assessment is delivered as a structured feasibility memo before study design is finalised, allowing sponsors to make informed data source decisions before governance procedures are initiated.

Federated Analytics and Privacy-Preserving Approaches

Where data cannot be extracted from its original environment, APICES supports federated analytics approaches – running analytical code within the data environment rather than extracting individual-level data. APICES participates in DARWIN EU, the EMA-supported federated data network for pharmacovigilance studies, enabling regulatory-grade pharmacoepidemiological analysis across OMOP CDM-standardised data in multiple EEA member states.

What You Can Expect

• Existing relationships with major European RWD holders, reducing access timelines by 3–6 months
• Data source suitability assessment before governance procedures are initiated
• End-to-end data access negotiation and licensing management
• GDPR-compliant governance framework designed for the specific data source and study
• DARWIN EU access for OMOP CDM federated analyses in EU pharmacovigilance-grade studies
• Multi-country governance coordination under a single data management framework

Frequently Asked Questions

Which European real-world data sources can APICES access?

National claims and reimbursement data, hospital and EHR networks, disease registries, primary-care and prescription panels, and patient-reported outcomes – across France (SNDS), Germany, Spain, Italy, the Netherlands, and the UK.

How do you handle GDPR for multi-country RWE?

Each study has a documented data-protection impact assessment, country-specific data-flow design, and contractual governance with the data holders. We coordinate ethics and information-governance approvals where required.

Can you negotiate data licences on the sponsor's behalf?

Yes. We have existing relationships with major European data holders and run the licensing process end-to-end – reducing 3–6 months of typical sponsor lead time.

Do you support pseudonymisation and federated analytics?

Yes. Where data cannot leave its environment, we run federated analyses through partner platforms (e.g., DARWIN EU partners, OMOP CDM environments) with appropriate governance.

How fast can data sourcing be set up?

For pre-existing partner data sources: 4–8 weeks from contract signature to data ready. New source negotiations typically take 3–6 months.