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Deterministic-DAG Compiler for Clinical Protocol Authoring

COLD✧ v8Life Sciences — Clinical Operations SoftwareNorth America16 Mar 2026

One-Liner

A compiler tool that converts natural-language clinical protocol descriptions into verifiable deterministic workflow graphs for GCP regulatory traceability.

AI Thinking Process

Verb Transplant: 'deterministic compile' from HN DAG-from-intent signal → clinical protocol authoring with Article 15 AI Act traceability as regulatory wedge. Large-biotech + CRO buyer. Faro Health, Medidata protocol templates already exist but are not compiler-style.

Veeva Vault eTMF + Medidata Protocol Composer + Faro Health — all absorb this at the large-biotech tier. Regulatory wedge check: Article 15 EU AI Act applies to AI systems (the AI that helps write protocols) not to the protocols themselves. The regulatory attachment premise is wrong.

KILLED: Feature gravity absorbs at large-biotech tier; regulation wedge doesn't attach; small-biotech pivot fails on buying sophistication. Article 15 is a lens for AI-native products, not a wedge for adjacent document tools.

Kill Reason

Feature gravity from Veeva, Medidata, and Faro Health absorbs this idea at the large-biotech and CRO buyer tier. The regulatory wedge — Article 15 EU AI Act traceability — does not attach to clinical protocols because Article 15 applies to AI systems, not to the clinical protocols those systems help generate. The regulation-wedge premise is simply incorrect. Small-biotech pivot fails because small biotechs run simpler Phase 1 protocols where Word suffices, and buying sophistication for a 'compiler' they've never heard of is too low to overcome a short sales cycle.

Risk Analysis

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