In today’s rapidly evolving regulatory and digital landscape, Real-World Evidence (RWE) is becoming a cornerstone of informed decision-making in the biotech and pharmaceutical industries. Regulators are increasingly recognising the value of RWE for product development and post-market follow-up, and are providing more guidance in this area.
Yet, navigating this landscape can be challenging. One of the first and most critical steps is correctly classifying your RWE project. This classification determines whether your study is considered interventional, non-interventional, or falls under another regulatory category. It directly impacts the compliance requirements, ethical review processes, and data handling standards you must follow.
Once you know the classification, you can begin to plan and prepare your project in more detail. This includes conducting a country feasibility study, creating your study plan and protocol, developing the necessary materials, setting up your data acquisition tool, and preparing any required submissions. You will then be able to outline the course of your project on your specific project map.
🔍 Example: Imagine planning a registry-based study to assess long-term treatment outcomes. If the study is incorrectly classified as non-interventional when it actually involves active patient follow-up or data collection beyond routine care, you risk non-compliance with regulatory expectations. This could delay approvals, compromise data integrity, or even invalidate your findings. Getting it right from the start is essential—and that’s where LINK Medical comes in.
Your Nordic Partner for RWE
LINK Medical is a leading Nordic CRO and regulatory service provider offering full-spectrum RWE support—from strategy and study design to execution and market access. With deep local expertise and a hands-on approach, we help you generate meaningful insights from real-world data (RWD) to support regulatory submissions, health technology assessments, and post-authorization studies.
Our dedicated RWE department is led by Hedda Magnusson, MSc in Pharmacy, with over 20 years of experience in clinical and RWE research. In her years working with RWE projects, she has seen how the perception of observational studies and RWE has evolved to become more scientifically robust and widely accepted. She says:
