clinical-trial-protocol-skill

To generate a clinical trial protocol for FDA submission, you need a structured draft covering rationale, endpoints, study design, and statistics. This skill creates NIH/FDA-ready markdown protocols by synthesizing ClinicalTrials.gov evidence and applying regulatory pathway logic.

Calculating sample size for a clinical trial protocol requires statistical power analysis for continuous or binary endpoints. This skill runs local calculations using scipy and numpy scripts to automate the statistical power computations needed for your protocol draft.

Drafting a Phase 2 or Phase 3 clinical trial protocol involves structuring objectives, population, intervention details, and operations. This skill uses a waypoint-based orchestration to build complete preliminary protocol drafts step-by-step for stakeholder review.

Yes, this clinical trial protocol generator supports both drugs and medical devices by synthesizing evidence and regulatory pathways. It tailors the regulatory-structured protocol output to match the specific requirements of your intervention type.

Yes, you can use ClinicalTrials.gov data to inform your clinical trial study design. This skill utilizes a ClinicalTrials.gov MCP connection to research similar trials and gather evidence that guides your protocol's design choices.

Automated clinical protocol generation produces preliminary drafts for stakeholder review rather than final regulatory submissions. You should use the research-only mode for evidence gathering or the full end-to-end mode for a draft, followed by expert clinical and regulatory validation.