{"product_id":"clinical-trial-protocol-gap-analyzer","title":"Clinical Trial Protocol Gap Analyzer","description":"\u003cdiv\u003eAnalyzes 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.\u003c\/div\u003e\u003cdiv\u003e\u003c\/div\u003e\u003cdiv\u003e\u003cem\u003eThis skill is delivered as a \u003ccode\u003e.zip\u003c\/code\u003e archive containing the skill in a named folder, matching the Anthropic SKILL.md format. Extract directly into your Claude Code skills directory (\u003ccode\u003e~\/.claude\/skills\/\u003c\/code\u003e) to install — or open and paste the contents into Claude.ai, ChatGPT, or any other AI tool.\u003c\/em\u003e\u003c\/div\u003e","brand":"penguin tree ai","offers":[{"title":"Default Title","offer_id":52471402299694,"sku":"clinical-trial-protocol-gap-analyzer","price":5.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0982\/4203\/6014\/files\/clinical-trial-protocol-gap-analyzer_555348c9-9903-40ef-be16-c391330e00ad.png?v=1787002464","url":"https:\/\/penguintree.ai\/products\/clinical-trial-protocol-gap-analyzer","provider":"penguin tree ai","version":"1.0","type":"link"}