The European Health Data Space Is Now Law: What Pharma and MedTech Teams Need to Know Before 2029
Published 05.08.2026 — MEDDDICAL Editorial The European Health Data Space Regulation (Regulation EU 2025/327) entered into force on 26 March
German Health Data Providers Compared: Claims Data Access, GDNG Compliance and RWE Fit for Pharma Research
Germany has one of the most analytically valuable health data environments in Europe — and one of the most structurally
AI-Generated Synthetic Health Data — What Pharma Teams Need to Know
The objection arrives reliably in every meeting where synthetic health data is proposed for the first time: “But isn’t it
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Outcome Prediction Models in Healthcare: Using RWD to Build Predictive Analytics
Here’s the version of predictive modelling in pharma that doesn’t get discussed enough in vendor conversations: the one where the
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Longitudinal Data Analysis in Pharma: What Makes a Dataset Fit for Purpose
Here’s a pattern we see repeatedly in the RWE programmes we advise on across Continental European markets: a company selects
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RWE FDA Regulatory Submission Guide: What FDA and EMA Now Accept as Real-World Evidence for Drug Approval and Label Expansion
In December 2025, the FDA announced it was eliminating a major barrier to using real-world evidence in drug and device
How to Make the Case for RWE Investment Internally: A Guide to Pharma Data Procurement, GDPR Compliance and Stakeholder Buy-In
Here’s a scenario that will feel uncomfortably familiar to anyone who has tried to initiate a real-world data programme inside
Rare Disease RWE Strategy: Synthetic Control Arms, Natural History Studies and Real-World Evidence for Orphan Drug Development
Here’s a conversation I’ve had more times than I can count. A clinical development director at a rare disease biotech
Pharma Competitive Intelligence with Real-World Evidence: Tracking Competitor Treatment Patterns, Prescribing Shifts and Real-World Market Share
The Intelligence Gap That’s Costing Brand Teams Strategic Ground Here’s a scenario that plays out more often than anyone in
RWE Strategy for Small Pharma: A Strategic Plan for Pharmaceutical Companies Without a Dedicated Real World Evidence Team
Here’s the assumption that gets small and mid-size pharma companies into trouble more often than any other: that real-world evidence