Building external control arms with confidence: A playbook for emerging biopharma

For emerging biopharma teams evaluating single-arm or hybrid trial designs, this playbook explains how to build external control arms (ECAs) that contextualize single-arm results, strengthen regulatory and HTA submissions, and inform better development decisions - from fit-for-purpose assessment through study execution and health authority engagement.

Access the playbook to learn: 

• What makes an ECA credible - and when to use one. Understand ECA design choices, FDA-aligned fit-for-purpose criteria, and why health authority engagement is critical to success

• Why ECAs matter for emerging biopharma. See how ECAs fill evidence gaps in rare, biomarker-defined, and fast-moving oncology settings, and deliver value well before submission - from go/no-go decisions and trial planning to regulatory and HTA support.

• Flatiron's two-phase approach to de-risking ECAs. Learn how Flatiron validates fit-for-purpose data and study feasibility and provides a curated dataset with analytics support to ensure submission-ready evidence