Skaldi is an AI platform for clinical and regulatory medical writing. We generate audit-ready Investigator's Brochures, Clinical Study Reports, Protocols, ICFs, and other regulatory documents — not just text, but traceable, source-linked documentation with cross-document coherence enforced by design.

What takes months of manual writing and reconciliation, Skaldi compresses to days. Every output is built for FDA, EMA, and ICH compliance, with full audit trails and zero patient data exposure.

Founded by an MD and a clinical research professional who spent a combined 20+ years writing regulatory documents by hand — and decided to build the tool they wished they'd had.

www.skaldi.co

Skaldi

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