Ich Gcp

clinical-research helps teams design prospective clinical studies before submission, with endpoint classification, two-arm sample size and power estimates, and feasibility phase-gate scoring. It includes Python tools, references, and a protocol synopsis template, while keeping outputs as estimates for clinician, biostatistician, and regulatory review.

clinical-reports is a structured writing skill for clinical case reports, diagnostic reports, clinical trial reports, and patient documentation. It supports CARE, ICH-E3, HIPAA, FDA, and ICH-GCP workflows, with clear templates and guidance for accurate, de-identified, publication-ready clinical writing.