Real-World Data
Reimagining the possibilities of evidence generation
Having pioneered real-world data in oncology, Flatiron now leads a vision of integrated evidence, harnessing new approaches to evidence generation. Find out how we are working across the globe to accelerate R&D and access, make research more inclusive, and make healthcare more sustainable.
Why the leading global life sciences companies work with Flatiron
- Engaged Care Network
Every day, community clinics and academic medical centers rely on Flatiron to power smarter care. With Flatiron technology integrated directly at the source – we’ve built the foundation for high quality evidence generation to enable industry-leading research.
- Global regulatory experience
Working with our biopharma partners, we have supported briefing packages in the U.S., Europe and Asia. And today, Flatiron evidence is increasingly used in submissions to the FDA, EMA and PMDA.
- Learning from real-world experience
We offer 20+ tumor-specific and pan-tumor datasets with deep clinical, genomic and outcomes variables. Leveraging new approaches to evidence generation, we’re now seamlessly integrating clinical research and insight generation into everyday care.
- Fit-for-purpose scientific methods and tools
Integrated evidence is different – as such, it requires specialized tools and methods to generate robust clinical insights.
- Expertise at every stage of the life cycle
From oncologists to quantitative scientists and regulatory affairs experts, our people have a track record of delivering industry firsts throughout the drug life cycle.
- Featured in 350+ peer-reviewed publications
Our real-world evidence powers research published in the world’s leading peer-reviewed scientific journals. Flatiron’s publication record reflects our deep industry partnerships and commitment to advancing scientific methods.
Advancing the use of RWE with our research collaborators
A biopharma company used Flatiron real-world data to identify prognostic biomarkers and their associated outcomes in NSCLC.
Proven track record and offerings across every stage of the drug life cycle
Discovery & early development
Our real-world evidence bridges the gap between genomics and clinical outcomes. Integrating previously siloed data modalities unlocks new possibilities for real-world data earlier in the life cycle.
Hear how RWE showed the prognostic significance of two biomarkers
Clinical research
Our real-world data and technology solutions are closing the gap between clinical care and clinical research. We use our deep expertise in data and technology to design more effective protocols, surface eligible patients at the point of care, and reduce the operational complexity of data collection, enabling more seamless and efficient research.
Regulatory Approval
As the pioneer in real-world evidence for oncology, Flatiron has a longstanding track record of supporting RWE submissions to regulators globally. Since 2016, the FDA and Flatiron have worked directly through a research collaboration to advance the use of real-world evidence to inform regulatory decision-making.
Post-Approval
Flatiron evidence plays a crucial role in post-approval efforts. Beyond post-marketing requirements, Flatiron data supports market tracking, assessment of real-word outcomes, and label updates in both Europe and the U.S.
Market access
HTA bodies around the world have assessed our real-world data as part of reimbursement evaluations for new medicines. Today, Flatiron real-world data supports access for patients on a global scale.
Our products
The world’s leading biopharma companies use Flatiron real-world data products to accelerate R&D and access, make research more inclusive, and make healthcare more sustainable.
Enhanced Datamart
Our foundational data subscriptions, covering 20+ tumor types, reflect cancer patients’ journeys from diagnosis to treatment, including standard-of-care diagnostics and real-world outcomes.
Spotlight Project
Spotlight projects provide fit-for-purpose data, building on our subscription offerings, and expertise tailored to answer our partners specific research questions. These projects may include additional data variables not captured in our syndicated offerings, as well as expert analytic, regulatory and HTA support.
Clinico-Genomic Database
Real-world datasets that link broad genomic profiling data with clinical data for patients in the Flatiron network who are tested with a Foundation Medicine assay.
Linked EHR and Claims Data
Unlock the full longitudinal patient journey by integrating evidence through a real-world linked EHR-Claims data solution that is longitudinal, de-identified, and ready for use.
Linked EHR and Radiology Imaging Data
Datasets integrating evidence that link radiology images (DICOM) with Flatiron’s EHR-derived clinical and outcomes data for disease-specific and disease-agnostic analyses.
Add-ons to our products:
Real-world outcome variables
Flatiron’s real-world outcomes variables are used to derive real-world endpoints. They account for the inherent complexities of patient outcomes specific to each cancer type.