Ledidi AS and NordicRWE AS have entered a strategic partnership to develop and conduct hybrid real-world evidence (RWE) studies and pragmatic clinical trials across the Nordic region.
The partnership combines Ledidi's regulatory-grade platform for structured clinical data capture with NordicRWE's expertise in epidemiology, biostatistics and registry-based research. It is open to pharmaceutical, biotech, medtech and academic research organisations.
Why it matters
Clinical decisions — by physicians, health authorities and payers — depend on evidence that reflects how treatments perform in real-world patient populations, not only in controlled trial settings. The Nordic health registries are among the most comprehensive in the world, covering entire populations over decades. But they were built for administrative and public health purposes, and typically lack granular clinical information: patient-reported outcomes, biomarkers, functional status and quality of life.
This limits their usefulness for questions that matter most to patients and clinicians — such as which subgroups respond to a given therapy, how treatment outcomes compare in routine practice, and whether benefits observed in trials hold across heterogeneous populations.
What the partnership does
The collaboration addresses this through two complementary approaches:
Hybrid observational studies that combine structured prospective data collection — capturing symptoms, biomarkers, quality of life and other clinical detail at the point of care — with longitudinal linkage to national registries in Norway, Sweden, Denmark and Finland. This produces datasets with both clinical depth and population-level follow-up, enabling research into treatment effectiveness, safety and patient heterogeneity that neither source can deliver alone.
Pragmatic randomised controlled trials (pRCTs) embedded in routine clinical practice across Nordic healthcare systems. These trials retain the rigour of randomisation while recruiting from real-world patient populations and tracking outcomes through existing registry infrastructure — making them faster, less costly and more generalisable than conventional RCTs.
Across both approaches, the partnership enables:
- Detailed characterisation of patients at treatment initiation across countries
- Long-term follow-up of clinically relevant outcomes including hospitalisations, disease progression and mortality
- Evidence on endpoints that registries cannot capture — particularly patient-reported outcomes and functional measures
- Scalable, multi-country execution within the harmonised Nordic data environment
How evidence reaches patients
The evidence generated through these studies is intended to inform the decisions that directly affect patient access to treatment: health technology assessments, reimbursement submissions and clinical guideline development. By producing evidence grounded in routine clinical practice, the partnership aims to reduce the gap between regulatory approval and the real-world information clinicians and health authorities need to make informed treatment decisions.
Preferred partner arrangement
Under the agreement, NordicRWE will use Ledidi as its primary platform for prospective data capture and hybrid study execution, while Ledidi will collaborate with NordicRWE as its preferred partner for scientific design, registry analytics and epidemiological methods.
“'The Nordic registries represent an extraordinary research asset, but realising their full potential for sponsors requires structured prospective data that captures what registries cannot. Together with NordicRWE, we can offer a seamless pathway from study design through data capture to registry-linked outcomes — all within a single, secure infrastructure."
— Einar Martin Aandahl, CEO of Ledidi
“Hybrid real-world evidence and pragmatic clinical trials unlock a new level of evidence by combining deep clinical phenotyping with population-scale Nordic registry data. This partnership enables faster, more relevant and decision-ready evidence for launch, HTA and lifecycle management — supported by NordicRWE’s expertise in real-world evidence and Ledidi’s secure and scalable infrastructure.”
— Christian Jonasson, Research Director of NordicRWE
