ClinStacks

Where AI meets regulatory reality in clinical trials

Decision intelligence for clinical trial design. Protocol validation, AI tool stacks, and regulatory compliance — built by practitioners who work with clinical data, not just write about it.

1,060+
AI submissions to FDA since 2016
22,704
Phase 2 oncology trials analyzed
290pg
ISPE GAMP AI guide (2025)
10
FDA-EMA joint AI principles

Built by practitioners, for practitioners

10+ years in clinical data infrastructure, medical imaging, and trial data pipelines. We write what we know — and what LLMs can't tell you from a single prompt.