penguin tree ai
Clinical Trial Protocol Gap Analyzer
Clinical Trial Protocol Gap Analyzer
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$5.00 USD
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$5.00 USD
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Analyzes a clinical trial protocol against ICH E8(R1)/E6(R3), FDA and EMA requirements, and design best practices to produce a structured gap list with severity ratings, regulatory citations, and recommended fixes across 10 protocol domains — plus a submission-readiness verdict. Use when reviewing a draft or existing protocol for design gaps, regulatory risk, IND/CTA readiness, or amendment-prevention before finalization.
This skill is delivered as a
.zip archive containing the skill in a named folder, matching the Anthropic SKILL.md format. Extract directly into your Claude Code skills directory (~/.claude/skills/) to install — or open and paste the contents into Claude.ai, ChatGPT, or any other AI tool.