Real-world evidence (RWE) is built on the premise that data generated during routine clinical care can reveal how medicines and interventions actually perform outside the environment of controlled trials. Electronic health records (EHRs) and disease registries are often treated as the foundational infrastructure of this approach. To improve data quality, many systems increasingly rely on… Continue reading The Hidden Architecture of RWE: When Complete Data Stop Being True Data
Category: Real World Evidence
The RWE Paradox: Plenty of Data, Fragile Structure
For more than a decade, we have framed real-world evidence (RWE) challenges as a data problem. Not enough access. Not enough scale. Not enough linkage. Not enough quality. However, this narrative has become increasingly difficult to sustain. Across major markets, data availability has expanded, platforms have matured, and analytical methods have become more standardized and… Continue reading The RWE Paradox: Plenty of Data, Fragile Structure
EHDS Section 60: The Illusion of Neutral Data Sharing?
Reading the EHDS regulation carefully, and in particular Section 60, leaves a sense of discomfort that is not really about legal drafting, but about how knowledge is produced and legitimized. The text is cautious, layered with safeguards, and repeatedly reassures the reader that intellectual property, trade secrets, and commercial confidentiality remain protected. And yet, between… Continue reading EHDS Section 60: The Illusion of Neutral Data Sharing?
European Health Data Space (EHDS): Status, Implications for Patients and Doctors
What the EHDS is and why it was established The European Health Data Space (EHDS) is a European Regulation (EU 2025/327) that entered into force in March 2025. It creates a common framework for using electronic health data across the European Union (EU). The main motivation behind the EHDS is the increasing need for… Continue reading European Health Data Space (EHDS): Status, Implications for Patients and Doctors
Do Pharma Still Need Large CROs for RWD Studies?
In the traditional model of real-world evidence (RWE) generation, sponsors relied almost automatically on contract research organizations (CROs) to manage observational studies end to end. That model made sense when data were fragmented, technology limited, and sponsors lacked internal capacity. Today, the landscape is very different. Data networks are richer, analytical platforms are significantly more… Continue reading Do Pharma Still Need Large CROs for RWD Studies?