117 件 ・ 関連度順
概要と使いどころ
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.
日本語の概要は準備中です。原文の説明を表示しています。
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.
日本語の概要は準備中です。原文の説明を表示しています。
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 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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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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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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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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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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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.
日本語の概要は準備中です。原文の説明を表示しています。
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.
日本語の概要は準備中です。原文の説明を表示しています。
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.
日本語の概要は準備中です。原文の説明を表示しています。
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.
日本語の概要は準備中です。原文の説明を表示しています。
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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Query DDInter drug-drug interactions via REST API (1.7M+ interactions, 2,400+ drugs). Search by drug name/ID for severity (major/moderate/minor), mechanisms, and clinical recommendations. No auth. For FDA labeling use dailymed-database; for pharmacogenomics use clinpgx-database.
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Addresses HIPAA compliance for mobile health (mHealth) applications, wearable devices, and remote patient monitoring. Covers OCR guidance on mobile device PHI, FDA-regulated mobile medical applications, FTC Health Breach Notification Rule for non-HIPAA apps, BYOD policies, and encryption requirements for ePHI on mobile platforms. Keywords: mHealth, mobile health, HIPAA mobile, wearable, remote monitoring, BYOD, mobile device management, app privacy.
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Addresses healthcare AI privacy at the intersection of HIPAA and the EU AI Act for clinical decision support systems. Covers training data PHI handling, model transparency and explainability, patient rights in algorithmic decisions, FDA/OCR regulatory coordination, and bias monitoring. Keywords: healthcare AI, HIPAA, AI Act, clinical decision support, PHI training data, model transparency.
日本語の概要は準備中です。原文の説明を表示しています。
Device-track catalyst analysis: 510(k), PMA, and De Novo decision events, CMS coverage and NTAP milestones, recalls and watch actions as risk signals, and post-market surveillance obligations — dated, verified, and sized per event for any medtech ticker or watchlist.
日本語の概要は準備中です。原文の説明を表示しています。
Med-sector overview across med.medicines_biotech and med.medical_devices with med trends, catalysts, FDA-decision context, and a cross-sector ripple map (quantified sign/magnitude per name). Use to frame any biotech/pharma/device analysis before diving into a single name.
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Med-adapted earnings preview: consensus estimates, historical surprises, guidance sensitivities, and the FDA-catalyst overlay (PDUFA/AdCom/trial readouts near the print) for biotech/pharma names.
日本語の概要は準備中です。原文の説明を表示しています。