124 skills · sorted by relevance
Plan a prospective clinical study by ranking endpoints, estimating participant numbers and statistical power, and assessing feasibility. Outputs include assumptions and named reviewers, providing material for expert review before a protocol is finalized.
Coordinate compliance work across multiple standards and regulations. Use a company profile to identify relevant frameworks, map shared controls, prepare mock audits, and build a unified evidence checklist showing where documents can be reused.
Review startup contracts and investment terms to identify risky clauses, prepare negotiation proposals, and organize questions for qualified attorneys. It also covers intellectual property ownership and regulatory exposure, helping founders prepare for legal review.
Guides migration of existing codebases to Rust without unsafe code, covering architecture, implementation, testing, and output comparisons. It measures performance before and after optimization and produces an interactive HTML report documenting results and unresolved differences.
Continue regulatory research when official sources cannot be accessed. The skill uses alternative sources or established regulatory knowledge to draft summaries and checklists, while documenting limitations and identifying the need for verification against current official requirements.
Comprehensive toolkit for preparing ISO 13485 certification documentation for medical device Quality Management Systems. Use when users need help with ISO 13485 QMS documentation, including (1) conducting gap analysis of existing documentation, (2) creating Quality Manuals, (3) developing required procedures and work instructions, (4) preparing Medical Device Files, (5) understanding ISO 13485 requirements, or (6) identifying missing documentation for medical device certification. Also use when users mention medical device regulations, QMS certification, FDA QMSR, EU MDR, or need help with quality system documentation.
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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, H&P, discharge summaries). Full support with templates, regulatory compliance (HIPAA, FDA, ICH-GCP), and validation tools.
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Analyze Stockbee-style Day 1 Episodic Pivot candidates from earnings, guidance raises, M&A, FDA/regulatory approvals, analyst actions, major contracts, product launches, short-squeeze catalysts, or theme/story events. Scores catalyst quality together with gap/range expansion, volume shock, neglect/revaluation context, liquidity, and risk to the EP-day low. Use when the user asks for EP candidates, episodic pivots, Day 1 catalyst trades, game-changing news reactions, delayed EP watchlists, or handoffs into PEAD monitoring.
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Use when cleaning clinical trial data, preparing data for FDA/EMA submission, standardizing SDTM datasets, handling missing values in clinical studies, detecting outliers in lab results, or converting raw CRF data to CDISC format. Cleans and standardizes clinical trial data fo...
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Prepare FDA/EMA regulatory submissions (IND/NDA/BLA/510(k)/PMA/MAA) in CTD format. Generate module outlines (Modules 1-5), run ICH compliance checks (ALCOA+, E6 GCP, Q1-Q12), verify data integrity, and produce submission-ready dossiers with cover letters and checklists.
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Generates CIOMS I-compliant ICSR narratives from adverse event case data for FDA and EMA regulatory submission. Includes temporal analysis, MedDRA coding, causality assessment using WHO-UMC or Naranjo criteria, and multi-format output.
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Use this skill to create fillable Word forms (.docx) with real Content Controls (SDT) + legacy FormField checkboxes + MERGEFIELD mail-merge placeholders + document protection. Trigger on: 'fillable form', 'form fields', 'content controls', 'SDT', 'word form', 'fill in', 'only editable fields', 'protect document', 'onboarding form', 'HR intake', 'survey template', 'contract / SOW template', 'mail-merge template', 'compliance checklist', 'medical intake questionnaire'. Output is a single .docx where specific fields are editable and the rest is locked. This skill is INDEPENDENT, not a scene layer on docx — payload is `<w:sdt>` + `<w:ffData>` + `<w:fldChar>` + `documentProtection`, none of which docx base skill covers. Do NOT trigger for regular reports, letters, memos, academic papers, pitch decks, or any document with no user-fillable fields — route those to officecli-docx or its scene layers.
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Use this skill to create fillable Word forms (.docx) with real Content Controls (SDT) + legacy FormField checkboxes + MERGEFIELD mail-merge placeholders + document protection. Trigger on: 'fillable form', 'form fields', 'content controls', 'SDT', 'word form', 'fill in', 'only editable fields', 'protect document', 'onboarding form', 'HR intake', 'survey template', 'contract / SOW template', 'mail-merge template', 'compliance checklist', 'medical intake questionnaire'. Output is a single .docx where specific fields are editable and the rest is locked. This skill is INDEPENDENT, not a scene layer on docx — payload is `<w:sdt>` + `<w:ffData>` + `<w:fldChar>` + `documentProtection`, none of which docx base skill covers. Do NOT trigger for regular reports, letters, memos, academic papers, pitch decks, or any document with no user-fillable fields — route those to officecli-docx or its scene layers.
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Prepares statistical reports for clinical trials following CONSORT 2025, SPIRIT 2025, ICH E9(R1) estimands, and FDA 2023 covariate adjustment guidance. Covers Table 1 generation, analysis populations (ITT/FAS/PP/Safety), the 5 ICH E9(R1) intercurrent-event strategies, MMRM under MAR (mmrm), reference-based MI (rbmi J2R/CR/CIR), Permutt tipping-point sensitivity, and Rubin's-rules vs frequentist variance debate. Use when preparing regulatory submissions, defining estimands, or implementing missing-data sensitivity analyses.
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Computes and interprets treatment effect measures (OR, RR, RD, HR, NNT) with calibrated confidence intervals (Wilson, Newcombe, Miettinen-Nurminen, MOVER, profile likelihood, Bender NNT) and reports marginal vs conditional estimands per FDA 2023 covariate adjustment guidance. Use when reporting treatment effects in confirmatory trials, comparing effect sizes across studies, or constructing forest plots.
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Calls microsatellite instability from WES/WGS/targeted-panel with MSIsensor, MSIsensor-pro, MSIsensor-ct (panel-aware), mSINGS, and MANTIS for FDA pembrolizumab MSI-H pan-tumor / Lynch syndrome / dMMR ICI biomarker. Use when stratifying ICI eligibility (Le 2015), pairing MSI with TMB-H (Sha 2020 / Salem 2018), screening Lynch syndrome (universal IHC + MSI), or distinguishing MSI-H tumors from POLE-exo hypermutator with overlapping signatures.
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Computes sample size and power for clinical trials including continuous, binary, and time-to-event endpoints; superiority, non-inferiority, and equivalence designs; FDA 2016 non-inferiority margin selection with M1/M2 framework; Schoenfeld 1981 and Lakatos 1988 for survival; Schuirmann TOST and 80-125% bioequivalence; minimum clinically important difference (MCID) vs δ distinction. Use when justifying trial size in protocol or SAP per CONSORT 2025 item 16a.
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Implements multiplicity control for confirmatory clinical trials using graphical procedures (Bretz-Maurer-Hommel), gatekeeping (parallel, serial, mixed), Hochberg/Hommel/Holm with PRDS, and the closed-testing principle (Marcus-Peritz-Gabriel; Goeman 2021 admissibility). Covers FDA Multiple Endpoints Final Guidance (October 2022), graphical procedures via R gMCP, primary + key-secondary + subgroup hierarchies, and FWER vs FDR distinction. Use when designing the multiplicity strategy for confirmatory trials with multiple primary or key secondary endpoints.
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Performs logistic regression for clinical trial outcomes (binary, ordinal, multinomial) with marginal-vs-conditional estimand reporting per FDA 2023 covariate adjustment guidance, g-computation/standardisation for marginal effects, modified Poisson for RR, Brant test for proportional odds, Firth penalty for separation, and Hauck-Donner detection. Use when modeling binary or ordinal endpoints in confirmatory or exploratory clinical trials.
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Senior Quality Manager Responsible Person (QMR) for HealthTech and MedTech. Use for management reviews, quality objectives and KPIs, quality culture, and Notified Body / FDA inspection prep per ISO 13485 Clause 5.5.2.
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The FDA Adverse Event Reporting System (FAERS) is a database used for the spontaneous reporting of adverse events and medication errors related to human drugs and therapeutic biological products. faers pacakge serves as the interface between the FAERS database and R. Furthermore, faers pacakge offers a standardized approach for performing pharmacovigilance analysis.
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Generate clinical trial protocols for medical devices or drugs. This skill should be used when users say "Create a clinical trial protocol", "Generate protocol for [device/drug]", "Help me design a clinical study", "Research similar trials for [intervention]", or when developing FDA submission documentation for investigational products.
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Generate clinical trial protocols for medical devices or drugs. This skill should be used when users say "Create a clinical trial protocol", "Generate protocol for [device/drug]", "Help me design a clinical study", "Research similar trials for [intervention]", or when developing FDA submission documentation for investigational products.
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Query the ClinPGx (formerly PharmGKB) REST API plus the CPIC PostgREST companion API for pharmacogenomic clinical annotations, CPIC/DPWG dosing guidelines, gene-drug pairs, variant-drug associations, FDA/EMA drug labels, and PGx pathways. Two-host architecture: api.clinpgx.org for annotation records, api.cpicpgx.org for genotype→recommendation lookups. No auth. For germline pathogenicity use clinvar-database; for somatic cancer PGx use cosmic-database or opentargets-database; for drug bioactivity use chembl-database-bioactivity.
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