The European Medicines Agency (EMA) and the European Medicines Regulatory Network (EMRN) have released the European Medicines Agencies Network Data Strategy, a comprehensive plan to strengthen how regulatory and real-world data (RWD) are managed, shared, and used across Europe. This strategy is central to the future of data-driven medicines regulation, emphasizing interoperability, FAIR data principles, and ethical data governance. At Sqilline Health, our mission to transform healthcare data into real-world evidence (RWE) aligns directly with EMA’s vision, empowering pharmaceutical companies to deliver safer, more effective, and more accessible treatments through trusted, compliant analytics.
Building a data-driven regulatory ecosystem
The EMRN’s Data Strategy represents a major step forward in how Europe leverages data to enhance public health. The strategy outlines a vision of “trusted medicines by unlocking the value of data” and focuses on turning regulatory and real-world data into actionable insights.
This framework positions the EMRN, and by extension, the European life sciences sector, at the forefront of data-driven regulation, fostering collaboration among regulators, healthcare systems, academia, and industry.
Sqilline Health’s role in the new regulatory landscape
At Sqilline Health, our business model is centered on the collection, structuring, and analysis of clinical data to unlock the value of real-world data (RWD) and real-world evidence (RWE) in support of:
- Patient access and commercialization strategies for pharmaceutical companies
- Clinical trials and post-marketing studies
- Scientific publications and informed decisions based on RWD and RWE
This focus naturally aligns with the EMRN’s strategy and the broader European vision for transparent, interoperable, and ethically managed healthcare data.
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Regulatory alignment
The EMRN emphasizes FAIR data (Findable, Accessible, Interoperable, Reusable) and strong data quality frameworks. Sqilline Health’s Danny Platform is built on these principles, helping pharma partners analyze data that meets European regulatory standards and supports decision-making across the product lifecycle.
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Evidence generation
The EMRN’s Data Strategy recognizes the growing importance of real-world data, such as electronic health records, patient registries, and spontaneous adverse event reports, in complementing clinical trial evidence and informing regulatory decisions. Sqilline’s technology supports this process by transforming fragmented electronic health records data into regulatory-grade insights, accelerating innovation and improving the evidence base for medicines evaluation.
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Trust framework and ethical data use
A key pillar of the EMRN’s strategy is data trusteeship, transparency, and security. Sqilline Health fully embraces these principles by implementing robust data governance practices that ensure all data are managed responsibly, ethically, and with the highest level of protection. As a trusted real world data (RWD) partner, Sqilline guarantees that information is used only for validated purposes and that all stakeholders, including healthcare professionals, regulators, and industry partners, can rely on the accuracy, integrity, and credibility of the insights generated.
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Innovation and artificial intelligence
The EMRN’s Data Strategy highlights the role of AI and advanced analytics in regulatory assessment and decisions. Sqilline Health is already leveraging these technologies to extract value from complex healthcare data, enabling regulatory-grade data analysis, early signal detection, and optimized patient access strategies.
Recognized data source within Europe’s RWD ecosystem
Sqilline Health’s Danny Platform is officially listed in the HMA-EMA Catalogue of Real-World Data Sources, contributing to the EMA’s initiatives to harness real-world data for regulatory decision-making. This recognition underlines Sqilline’s commitment to quality, interoperability, and transparency in data-driven healthcare innovation. View the listing in the HMA-EMA Catalogue of Real-World Data Sources.
The road ahead
The EMRN’s Data Strategy signals a new era of collaboration between regulators, healthcare providers, and technology innovators. It sets the foundation for a trusted, interoperable, and AI-enabled regulatory ecosystem, one where real-world evidence plays a central role in ensuring better access and safer treatments for patients.
At Sqilline Health, we are proud to help drive this transformation, building tools and frameworks that connect healthcare data with regulatory and clinical priorities. EMRN’s Data Vision: “Trusted medicines, powered by the value of data” correlates with Sqilline Health’s vision to deliver “Clarity for Cancer Care” by transforming oncology data into real-world evidence.
