A collaboration with the FDA: How Flatiron real-world evidence provides actionable insights

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Generating regulatory-grade real-world evidence: A data quality checklist

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The Clinico-Genomic Database: Advancing personalized medicine

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Above: A hypothetical analysis made possible by the Flatiron/Foundation Medicine Clinico-Genomic Database.

Integrated at the source. Expanded with linked data sets.

  • Derived from the EHRs of over 265 community clinics and academic institutions at over 800 unique sites of care.
  • The largest and highest quality source for real-world evidence in oncology – includes both structured and unstructured data.
  • Access to longitudinal clinical data, with the ability to link to external data sources like genomics, mortality and closed claims.

Designed to meet the most rigorous quality standards for RWE.

Technology-Enabled Abstraction

Patent-pending abstraction process carefully augments human expertise with machine learning and other technology-enabled optimizations.

Data Quality Control

Thorough quality assurance and complete data provenance for every data point generated.

Regulatory Collaborations

Active collaborations with the FDA and NCI to define the requirements and uses for regulatory grade RWE.

We used Flatiron’s data in more than 20 countries around the world and it accelerated the access for patients by more than a year for Alecensa in many of those countries.

Daniel O'Day — The Cancer Letter — March 2, 2018
CEO, Roche Pharmaceuticals

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