Real-World Evidence Services

Flatiron Health's Real-World Evidence (RWE) Services provide tailored oncology evidence solutions designed to help biopharma companies achieve their evidence goals faster and more efficiently. Partnering with Flatiron's multidisciplinary team of research oncologists, biostatisticians, epidemiologists, and regulatory specialists, life sciences organizations can accelerate development timelines, optimize evidence needs, and build compelling value stories across every phase of the biopharma lifecycle.

With over 12 years of exclusive focus in oncology, more than 5 years of direct collaboration with the FDA, and a track record of 350+ custom data and services projects delivered, Flatiron brings unmatched depth of expertise. The team has contributed to 50+ submissions to regulatory authorities and HTA bodies, and has co-authored 90+ publications with customers, with 500+ total publications featuring Flatiron data.

Areas of Research Supported

• Natural history studies and studies of unmet medical need
• Comparative effectiveness research, including external control arms
• Protocol optimization studies to improve inclusion of underrepresented populations
• Patient recruitment and site selection strategies to power clinical trial study designs and predict study timelines
• Reports to monitor uptake for newly approved assets and describe market share
• Assessments of transportability
• Real-world assessments of dosing patterns and drug safety
• Strategic support in interactions with regulators and briefing book development

Key Differentiators

• Multidisciplinary expertise: Services teams include research oncologists, biostatisticians, epidemiologists, and regulatory specialists skilled at applying RWE across the oncology drug lifecycle.
• Data empathy: With over a decade at the forefront of RWE innovation, Flatiron scientists bring a multi-faceted understanding of oncology RWE and its practical applications.
• Integrated at the source: Services leverage data from Flatiron's own electronic health record system, OncoEMR, integrated at the point of care, offering unmatched scale, clinical depth, and data quality.
• Published with partners: Flatiron has collaborated with leading organizations including the FDA, NCCN, and NICE to advance endpoint validation methods and RWE research.
• Flexible and cost-effective contracting: Engagement options are designed to allow life sciences companies to choose a solution that best fits their needs and budget.

Flexible Engagement Models

• End-to-end RWE support: Flatiron's expert team can lead and execute scientific research projects from study design and protocol optimization through analysis and publication, ensuring accurate and timely delivery of results.
• Ongoing analytical insights on a regular cadence: Flatiron provides continuous analytical support covering treatment patterns, treatment outcomes, patient persistence, and more, leveraging specialized oncology RWE knowledge.
• One-time insights for specific research or business questions: For rapid answers to critical questions, the team can generate actionable insights quickly to inform decision-making.
• Custom solutions: Flatiron can also work with partners to craft bespoke solutions tailored to unique evidence generation needs.

Success Stories

• Analytic insights for faster decisions: Flatiron provided ongoing RWE analytic support to a HEOR team at a top biopharma company, addressing key business questions spanning post-market strategy, trial design, and outcomes evaluation, while helping the client optimize their real-world data subscription.
• Comparative effectiveness in metastatic colorectal cancer: Flatiron supported a real-world comparative effectiveness study evaluating treatment-specific sub-cohorts within a biomarker-identified population to support HTA decision-making, recognized by the customer for scientific innovation and breadth of analytic capabilities.
• Unmet medical need evaluation for portfolio strategy: Flatiron's RWE study helped a biopharma executive team prioritize R&D investment across five therapeutic areas by establishing unmet need through real-world survival outcomes in patients with advanced urothelial carcinoma who had experienced disease relapse.

Flatiron's RWE Services are powered by the Flatiron Horizon platform and are built on data sourced directly from OncoEMR, ensuring clinical depth and quality at scale. The team's established relationships with regulatory bodies and HTA organizations, combined with flexible contracting models, make Flatiron a trusted partner for oncology evidence generation across the full drug development lifecycle.