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?
Category: Methodology
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?
Conducting Real-World Evidence (RWE) Studies in Obesity: Opportunities and Challenges
By Patrick Wulf Hanson (Reviewed, adjusted and approved by Dr. Frederik Persson, Head of Clinic, Steno Diabetes Center, Copenhagen, Denmark) 1. Introduction Globally, obesity has emerged as a critical public health challenge, contributing to substantial morbidity and mortality, and it is a leading risk factor for diseases such as type 2 diabetes, cardiometabolic… Continue reading Conducting Real-World Evidence (RWE) Studies in Obesity: Opportunities and Challenges
The Role of Real-World Data in HTA Reassessments
Health technology assessments (HTAs) are the foundation of evidence-based decision-making for reimbursement, and coverage of medicines and medical technologies. Traditionally, the process has been heavily anchored in evidence from randomized controlled trials (RCTs), assessed at the time of market entry. However, healthcare systems have been evolving and are increasingly shifting toward a lifecycle approach to… Continue reading The Role of Real-World Data in HTA Reassessments
Internal Data Platforms and Federated Data Models: Understanding the Difference
In the pharmaceutical industry, data has become a strategic asset. Companies are increasingly investing in technologies that enable them to manage, analyze, and derive insights from the enormous amounts of information they generate. As a data strategist, a frequent question I receive is how to build a platform that supports research, monitoring, and evidence generation… Continue reading Internal Data Platforms and Federated Data Models: Understanding the Difference