Clinical Pharmacology Protocol Development
Claude Code plugin that drafts Phase 1 clinical trial protocols, synopses, and consent forms.
About
This Claude Code plugin systematizes Phase 1 clinical pharmacology trial documentation: background research reports, synopses, full protocols in ICH E6(R3) structure, and informed consent forms. Eight specialized agents (clinical pharmacologist, translational scientist, regulatory expert, clinician, biostatistician, writers, QA reviewer) collaborate through a 10-phase pipeline with user review gates, covering FIH/SAD/MAD, drug-interaction, bioequivalence, food-effect, QTc, and ADME study types. The repo shows 102 commits, 6 releases, CI, and a fail-closed release gate that refuses to claim a pass when evidence recording fails.
Two things to know before relying on it. The documentation is primarily in Korean, which limits accessibility for non-Korean-speaking teams, though the install commands and workflow are straightforward. And the plugin's own disclaimer is the right frame: outputs are drafts for IRB submission, and every statistic, drug fact, and guideline citation needs expert verification before any regulatory use.
What it can do
- Phase 1 protocol drafting (FIH, DDI, BE, QTc, ADME)
- Synopsis generation with design variants
- Informed consent form drafting
- Sample-size calculation with Python code
- Multi-agent review with critical/major/minor triage
Setup
Register the marketplace with /plugin marketplace add kimmingul/clinical-pharmacology-study-protocol-development, then install with /plugin install clinical-pharmacology-study-protocol-development. Prepare a TRIAL_INFO.md with drug name and trial type, then run /research, /design, /synopsis, /protocol, /review, and /icf in sequence.
Prerequisites
Claude Code; drug name and trial type (investigator's brochure required for first-in-human studies); regulatory and statistical reviewers for output validation.
Use cases
Works with
Trust score — 7/10
Scored 7/10 (verified tier, metrics-v1). Evidence: 10 GitHub stars, MIT license, 102 commits, 6 releases, CI badge; Concrete install: /plugin marketplace add + /plugin install commands; 8-agent pipeline with review gates and fail-closed release gate; Caveat: docs primarily Korean; outputs are IRB-submission drafts needing expert review.
★ 10 GitHub stars
Sources
Every fact above was checked against these sources. Where a claim comes from the provider and couldn't be independently verified, the text says so.