Articles tagged with “virtual-control-arms”

Virtual Control Arms in Clinical Trials: Bias & Validation

How virtual and external control arms are built, validated, and regulated in 2026: FDA and EMA guidance, exchangeability, bias, sensitivity analysis, and documented case studies.

30 min read

9/5/2026

virtual control arms external control arm synthetic control arm single-arm trial clinical trials real world data FDA guidance regulatory science sensitivity analysis exchangeability

Digital Twins in Clinical Trials: Virtual Controls & FDA

Examine how digital twins in clinical trials function as virtual control arms. This report reviews FDA guidance, AI models, and implementation requirements.

40 min read

3/4/2026

digital twins clinical trials virtual control arms synthetic control arms fda guidance artificial intelligence digital patients computational modeling