Skill Packages
Browse ready-made AI workflow skills for document elaboration, review, and structuring.
Clinical Report Writing
Write comprehensive clinical reports including case reports (CARE guidelines), diagnostic reports (radiology, pathology, lab), clinical trial reports (ICH-E3, SAE, CSR), and patient documentation (SOAP notes, H&P, discharge summaries). Includes regulatory compliance and validation tools.
Learn MoreClinical Trial Protocol (ICH E6 R3)
Draft clinical trial protocols compliant with ICH E6(R3) and ICH E8(R1). Covers study design, objectives, endpoints, eligibility criteria, estimand framework (ICH E9(R1)), statistical analysis plan, safety monitoring, IDMC, RBQMS, and regulatory submission requirements (FDA IND / EU CTR 536/2014 via CTIS) for all study phases and therapeutic areas.
Learn MoreClinical Trial Protocol (ICH E6(R3) GCP)
Draft and validate clinical trial protocols per ICH E6(R3) Good Clinical Practice and ICH E8(R1) General Considerations for Clinical Studies. Ensures the protocol contains all required elements for ethics committee / IRB submission and regulatory filing (EMA, FDA IND, ANVISA).
Learn MoreCMMC Assessment Scoping
Define CMMC assessment scope, authorization boundary, and network architecture for Level 1 or Level 2. Documents in-scope assets and network diagram narrative for the SSP.
Learn MoreCMMC Asset Inventory
Create and maintain the CMMC asset inventory: CUI assets, security protection assets, and contractor risk-managed assets for assessment scope.
Learn MoreCMMC Plan of Action & Milestones
Draft and validate the CMMC POA&M: track control deficiencies, remediation plans, owners, and due dates for Conditional Level 2 or Level 3.
Learn MoreCMMC Policies and Procedures
Draft CMMC-aligned security policies and procedures for all NIST 800-171 domains: Access Control, Audit, Awareness, Configuration Management, and others.
Learn MoreCMMC Readiness Gap Analysis
Map controls to NIST SP 800-171 practices, identify CMMC coverage gaps, and build a prioritized remediation roadmap for Level 1 or Level 2.
Learn MoreCMMC System Security Plan
Draft and validate the CMMC SSP for Level 1 or Level 2: system description, boundary, and implementation narratives for each NIST 800-171 practice with evidence pointers.
Learn MoreCMMI-DEV Causal Analysis and Resolution
Draft CMMI-DEV Causal Analysis and Resolution (CAR) deliverables: causal analysis reports and action proposals for ML5.
Learn MoreCMMI-DEV Configuration Management
Draft CMMI-DEV Configuration Management (CM) deliverables: configuration management plan, baselines, and change request/status documentation for ML2.
Learn MoreCMMI-DEV Decision Analysis and Resolution
Draft CMMI-DEV Decision Analysis and Resolution (DAR) deliverables: decision records, evaluation criteria, and alternatives analysis for ML3.
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