npm - heor-agent-mcp - Versions diffs - 1.0.5 → 1.1.0 - Mend

heor-agent-mcp 1.0.5 → 1.1.0

This diff represents the content of publicly available package versions that have been released to one of the supported registries. The information contained in this diff is provided for informational purposes only and reflects changes between package versions as they appear in their respective public registries.

Files changed (29) hide show

package/README.md +12 -10
package/dist/providers/types.d.ts +2 -0
package/dist/providers/types.d.ts.map +1 -1
package/dist/pv/decisionTree.d.ts +23 -0
package/dist/pv/decisionTree.d.ts.map +1 -0
package/dist/pv/decisionTree.js +99 -0
package/dist/pv/decisionTree.js.map +1 -0
package/dist/pv/gvpModules.d.ts +20 -0
package/dist/pv/gvpModules.d.ts.map +1 -0
package/dist/pv/gvpModules.js +129 -0
package/dist/pv/gvpModules.js.map +1 -0
package/dist/pv/types.d.ts +27 -0
package/dist/pv/types.d.ts.map +1 -0
package/dist/pv/types.js +2 -0
package/dist/pv/types.js.map +1 -0
package/dist/server.js +10 -0
package/dist/server.js.map +1 -1
package/dist/tools/htaDossierPrep.d.ts.map +1 -1
package/dist/tools/htaDossierPrep.js +77 -0
package/dist/tools/htaDossierPrep.js.map +1 -1
package/dist/tools/maicWorkflow.d.ts +178 -0
package/dist/tools/maicWorkflow.d.ts.map +1 -0
package/dist/tools/maicWorkflow.js +309 -0
package/dist/tools/maicWorkflow.js.map +1 -0
package/dist/tools/pvClassify.d.ts +65 -0
package/dist/tools/pvClassify.d.ts.map +1 -0
package/dist/tools/pvClassify.js +198 -0
package/dist/tools/pvClassify.js.map +1 -0
package/package.json +2 -2

package/README.md CHANGED Viewed

@@ -18,16 +18,18 @@ Built for pharmaceutical, biotech, CRO, and medical affairs teams who need rigor
 ---
-## What's new in v1.0.4
+## What's new in v1.1.0
-Senior HEOR methodology + ChatGPT support:
+Pharmacovigilance + workflow orchestration:
-- **GRADE inconsistency now uses I²** instead of study count. Single-study comparisons return `not_assessable` (per Cochrane 10.10) instead of being silently auto-downgraded as "Serious". Pass `heterogeneity_per_outcome` to `hta_dossier` and the Cochrane bands (50–74% Moderate, 75–89% Serious, ≥90% Very Serious) are applied directly.
-- **GRADE upgrading (Guyatt 2011)** — observational evidence with strong effects can now be upgraded from Low. Three criteria via `upgrading_per_outcome`: large effect (RR <0.5/>2.0 → +1; <0.2/>5.0 → +2), dose-response (+1), plausible confounding biasing toward null (+1). Capped at +2.
-- **Bucher consistency check** — when direct head-to-head A-vs-C evidence exists alongside the indirect A-vs-C estimate, `evidence_indirect` automatically tests Bucher's consistency assumption and flags violations (NICE DSU TSD 18). |z|≥1.96 = "substantial — consistency assumption appears violated."
-- **EQ-5D 5L impact is baseline-utility-aware.** Biz 2026 reports category-level medians, but the new 5L value set compresses utilities in the 0.6–0.9 range — a drug for mild plaque psoriasis (baseline ~0.85) sees a much bigger ICER increase than one for severe HS (baseline ~0.45), even though both are `non_cancer_qol_only`. Pass `baseline_utility` to `utility_value_set` for a calibrated estimate.
-- **ChatGPT Custom GPT support** — new OpenAPI 3.1 adapter at `/api/openapi` lets you build a Custom GPT in 5 minutes. See [ChatGPT Custom GPT](#chatgpt-custom-gpt) below.
-- **Surface-tagged analytics** — every `tool_call` PostHog event now carries a `surface` property (`claude_anthropic_web` / `chatgpt_adapter` / `claude_desktop` / `direct_mcp`) so you can break down usage by client.
+- **`pv_classify` tool** — classifies a planned study into its EMA pharmacovigilance regulatory category (PASS imposed/voluntary, PAES, RMP Annex 4, DUS, active surveillance registry, pregnancy registry, spontaneous reporting, ICH E2E plan). Returns the matching GVP module (V/VI/VIII/VIII Addendum I), ENCePP protocol template ID, RMP implications, FDA analogue, and submission obligations. Pure decision-tree per EMA GVP rev 4 + EU Regulation 1235/2010 Article 107a. <200ms response.
+- **`hta_dossier` Pharmacovigilance Plan section** — pass `pv_classification` from `pv_classify` to `hta_dossier` and the dossier output now includes a PV Plan section between RoB and CEA. Without it, a one-line "PV plan not provided" note flags the gap so reviewers see what's missing.
+- **`maic_workflow` orchestrator** *(v1.0.6)* — runs the full MAIC discovery+screening pipeline (ITC feasibility + parallel literature_search + screening + RoB + network) in one MCP call. Built for ChatGPT-5.3 surfaces where chaining 5+ tool calls in parallel is unreliable; works equally well from Claude.
+- **`examples` tool** *(v1.0.5)* — pre-filled JSON inputs for heavy-schema tools (CEA, BIA, survival, MAIC, Bucher) plus a `maic_workflow_recipe` multi-step prompt template for ChatGPT users.
+- **CMS IRA awareness** — when `pv_classify` is called with US jurisdiction, output explicitly notes that CMS IRA Medicare price-negotiation calculations exclude PV cost data — track those obligations in the regulatory budget, not the HEOR cost-effectiveness model.
+- **GRADE I²-based inconsistency, GRADE upgrading (Guyatt 2011), Bucher consistency check, EQ-5D 5L baseline-utility-aware impact** *(v1.0.4)* — see [CHANGELOG.md](./CHANGELOG.md).
+- **ChatGPT Custom GPT support** *(v1.0.4)* — OpenAPI 3.1 adapter at `/api/openapi` lets you build a Custom GPT in 5 minutes. See [ChatGPT Custom GPT](#chatgpt-custom-gpt) below.
+- **Surface-tagged analytics** *(v1.0.4)* — every `tool_call` PostHog event carries a `surface` property (`claude_anthropic_web` / `chatgpt_adapter` / `claude_desktop` / `direct_mcp`).
 See [CHANGELOG.md](./CHANGELOG.md) for the full diff.
@@ -66,7 +68,7 @@ Add to your MCP configuration:
 ---
-## Tools (17)
+## Tools (20)
 | Tool | Purpose |
 |------|---------|
@@ -364,7 +366,7 @@ A companion chat interface is available at:
 **https://web-michael-ns-projects.vercel.app**
-- Chat with Claude Sonnet 4.6 + all 17 HEOR tools
+- Chat with Claude Sonnet 4.6 + all 20 HEOR tools
 - **BYOK (Bring Your Own Key)** — paste your Anthropic API key in the settings; it stays in your browser's localStorage and is never stored on our servers
 - Markdown rendering with styled tables, tool call cards with live progress timers, and theme-aware mermaid network diagrams
 - 12 example prompts covering literature search, CEA, BIA, NMA, ITC feasibility, RoB, EQ-5D 5L, EU JCA dossiers

package/dist/providers/types.d.ts CHANGED Viewed

@@ -108,6 +108,8 @@ export interface DossierParams {
         dose_response?: boolean;
         plausible_confounding_toward_null?: boolean;
     }>;
+    /** Optional structured PV classification from pv_classify — when provided, populates the Pharmacovigilance Plan section. */
+    pv_classification?: any;
 }
 export interface ToolResult {
     content: string | object;

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package/dist/pv/decisionTree.d.ts ADDED Viewed

@@ -0,0 +1,23 @@
+/**
+ * Pure decision logic for pv_classify. Maps a study's metadata onto its
+ * EMA regulatory category. See design log #11 for the decision-tree
+ * diagram and rationale per branch.
+ *
+ * Order matters:
+ *   1. Pre-authorisation overrides everything → ICH E2E plan.
+ *   2. Spontaneous reports stand alone (not a study).
+ *   3. RMP commitment context → Annex 4 study.
+ *   4. Imposed by authority + post-MA → PASS imposed.
+ *   5. Otherwise classify by primary objective + study design.
+ *   6. Pregnancy population overrides the primary verdict (keeps it as
+ *      an alternative for transparency).
+ */
+import type { PvCategory, PvClassifyInput } from "./types.js";
+interface Decision {
+    primary_category: PvCategory;
+    alternatives: PvCategory[];
+    rationale: string;
+}
+export declare function classifyPv(input: PvClassifyInput): Decision;
+export {};
+//# sourceMappingURL=decisionTree.d.ts.map

package/dist/pv/decisionTree.d.ts.map ADDED Viewed

	@@ -0,0 +1 @@
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package/dist/pv/decisionTree.js ADDED Viewed

@@ -0,0 +1,99 @@
+export function classifyPv(input) {
+    // 1. Pre-authorisation: never PASS — characterise via ICH E2E plan.
+    if (input.regulatory_context === "pre_authorisation") {
+        return withPregnancyOverride(input, {
+            primary_category: "ICH_E2E_pharmacovigilance_plan",
+            alternatives: [],
+            rationale: "Study is pre-authorisation. PASS designations require an existing marketing authorisation (Article 107a). Pharmacovigilance planning at this stage falls under ICH E2E and feeds the initial RMP at MAA submission.",
+        });
+    }
+    // 2. Spontaneous reports stand alone — Module VI baseline obligation.
+    if (input.study_design === "spontaneous_reports") {
+        return withPregnancyOverride(input, {
+            primary_category: "spontaneous_reporting_only",
+            alternatives: [],
+            rationale: "Spontaneous adverse-event reporting is the baseline PV obligation under GVP Module VI, not a designed study. Categorised as spontaneous_reporting_only.",
+        });
+    }
+    // 3. RMP commitment context → Annex 4 listed study.
+    if (input.regulatory_context === "rmp_commitment") {
+        const alts = input.imposed_by_authority
+            ? ["PASS_imposed"]
+            : ["PASS_voluntary"];
+        return withPregnancyOverride(input, {
+            primary_category: "RMP_Annex_4_study",
+            alternatives: alts,
+            rationale: "Study is an explicit RMP commitment, listed in RMP Annex 4 with milestone tracking. Per EMA GVP Module V.",
+        });
+    }
+    // 4. Imposed PASS — applies to conditional, accelerated, and standard
+    //    post-authorisation contexts when the authority has imposed the
+    //    obligation (Article 107n / 107a).
+    if (input.imposed_by_authority) {
+        return withPregnancyOverride(input, {
+            primary_category: "PASS_imposed",
+            alternatives: ["RMP_Annex_4_study"],
+            rationale: "Authority-imposed obligation in a post-authorisation context (Article 107n). Falls under GVP Module VIII as a Post-Authorisation Safety Study (imposed). PRAC pre-review of the protocol is required.",
+        });
+    }
+    // 5. Otherwise classify by primary objective + study design.
+    switch (input.primary_objective) {
+        case "safety":
+            return withPregnancyOverride(input, {
+                primary_category: "PASS_voluntary",
+                alternatives: ["active_surveillance_registry"],
+                rationale: "Safety-objective post-authorisation study without an imposed obligation → voluntary PASS under GVP Module VIII. ENCePP registration and a final report to EMA are encouraged but not mandatory.",
+            });
+        case "efficacy":
+        case "effectiveness":
+            return withPregnancyOverride(input, {
+                primary_category: "PAES",
+                alternatives: ["PASS_voluntary"],
+                rationale: "Effectiveness/efficacy-objective post-authorisation study → Post-Authorisation Efficacy Study (PAES). May trigger MA variation if results diverge from the MA effectiveness assumptions.",
+            });
+        case "drug_utilization":
+            return withPregnancyOverride(input, {
+                primary_category: "DUS",
+                alternatives: ["PASS_voluntary"],
+                rationale: "Drug utilisation objective → DUS under GVP Module VIII Addendum I. Used to characterise prescribing patterns and assess risk-minimisation measure effectiveness.",
+            });
+        case "natural_history":
+            return withPregnancyOverride(input, {
+                primary_category: "active_surveillance_registry",
+                alternatives: ["PASS_voluntary"],
+                rationale: "Natural history / disease epidemiology objective → active surveillance registry. Provides denominator data for PV signal detection.",
+            });
+        case "risk_minimisation_evaluation":
+            return withPregnancyOverride(input, {
+                primary_category: "PASS_voluntary",
+                alternatives: ["DUS"],
+                rationale: "Evaluation of risk-minimisation measure effectiveness → categorised as PASS (voluntary unless imposed). DUS is a valid alternative if the focus is utilisation rather than outcomes.",
+            });
+    }
+}
+function withPregnancyOverride(input, decision) {
+    if (!input.population_includes_pregnant)
+        return decision;
+    if (decision.primary_category === "ICH_E2E_pharmacovigilance_plan") {
+        // Pre-authorisation pregnancy planning still routes through ICH E2E
+        // but flag the pregnancy-registry follow-up as the post-MA step.
+        return {
+            primary_category: "ICH_E2E_pharmacovigilance_plan",
+            alternatives: ["pregnancy_registry"],
+            rationale: decision.rationale +
+                " Pregnancy population: a pregnancy registry will be required as a post-authorisation commitment per ICH E2E and EMA pregnancy-registry guidance.",
+        };
+    }
+    if (decision.primary_category === "pregnancy_registry")
+        return decision;
+    // Pregnancy override: keep the would-be primary as an alternative for
+    // transparency, promote pregnancy_registry to the primary verdict.
+    return {
+        primary_category: "pregnancy_registry",
+        alternatives: [decision.primary_category, ...decision.alternatives].filter((c, i, a) => a.indexOf(c) === i && c !== "pregnancy_registry"),
+        rationale: "Pregnancy population in scope → pregnancy registry takes priority over the primary classification. " +
+            decision.rationale +
+            " The original classification is retained as an alternative for protocol-design context.",
+    };
+}
+//# sourceMappingURL=decisionTree.js.map

package/dist/pv/decisionTree.js.map ADDED Viewed

@@ -0,0 +1 @@

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package/dist/pv/gvpModules.d.ts ADDED Viewed

@@ -0,0 +1,20 @@
+/**
+ * EMA Good Pharmacovigilance Practices (GVP) module + ENCePP template
+ * mapping per category. Source of truth: EMA GVP Rev 4.
+ *
+ * If EMA publishes Rev 5, bump GVP_REVISION + add a regression test that
+ * loads a known scenario and asserts the new module reference.
+ */
+import type { GvpModule, PvCategory } from "./types.js";
+export declare const GVP_REVISION: "rev_4";
+interface CategoryMapping {
+    gvp_module: GvpModule;
+    encepp_protocol_template?: string;
+    rmp_implications: string[];
+    fda_analogue?: string;
+    submission_obligations: string[];
+}
+export declare const CATEGORY_MAPPING: Record<PvCategory, CategoryMapping>;
+export declare function gvpFor(category: PvCategory): CategoryMapping;
+export {};
+//# sourceMappingURL=gvpModules.d.ts.map

package/dist/pv/gvpModules.d.ts.map ADDED Viewed

@@ -0,0 +1 @@

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package/dist/pv/gvpModules.js ADDED Viewed

@@ -0,0 +1,129 @@
+export const GVP_REVISION = "rev_4";
+export const CATEGORY_MAPPING = {
+    PASS_imposed: {
+        gvp_module: "VIII",
+        encepp_protocol_template: "ENCePP-PASS-001",
+        rmp_implications: [
+            "Update RMP Part III (PV Plan) to list this study as an imposed PASS.",
+            "Annex 4 of the RMP must reference the protocol and timelines.",
+        ],
+        fda_analogue: "FDA Postmarketing Required Studies (PMR)",
+        submission_obligations: [
+            "Protocol submission to PRAC for review prior to study start (Article 107n).",
+            "Annual safety update reports during conduct.",
+            "Final study report within 12 months of last data lock.",
+        ],
+    },
+    PASS_voluntary: {
+        gvp_module: "VIII",
+        encepp_protocol_template: "ENCePP-PASS-002",
+        rmp_implications: [
+            "Document study as a voluntary PASS in RMP Part III.",
+            "No PRAC pre-approval required; encouraged ENCePP registration.",
+        ],
+        fda_analogue: "FDA Postmarketing Commitment (PMC)",
+        submission_obligations: [
+            "Voluntary protocol notification to EMA EUPAS register.",
+            "Final study report when results available.",
+        ],
+    },
+    PAES: {
+        gvp_module: "VIII",
+        encepp_protocol_template: "ENCePP-PAES-001",
+        rmp_implications: [
+            "PAES results may trigger MA variation if effectiveness diverges from MA assumptions.",
+        ],
+        fda_analogue: "FDA Postmarketing Required Effectiveness Studies",
+        submission_obligations: [
+            "Protocol submission for PRAC review when imposed.",
+            "Periodic interim reports per MA condition.",
+        ],
+    },
+    RMP_Annex_4_study: {
+        gvp_module: "V",
+        encepp_protocol_template: "ENCePP-RMP-001",
+        rmp_implications: [
+            "Listed in RMP Annex 4 with study ID, status, milestone dates.",
+            "Study completion is a tracked RMP commitment.",
+        ],
+        fda_analogue: "FDA REMS Assessment Study",
+        submission_obligations: [
+            "Inclusion in every RMP update submitted to EMA.",
+            "Status reporting at PSUR cycles.",
+        ],
+    },
+    DUS: {
+        gvp_module: "VIII_Addendum_I",
+        encepp_protocol_template: "ENCePP-DUS-001",
+        rmp_implications: [
+            "DUS may be referenced in RMP Part III for risk minimisation effectiveness.",
+        ],
+        fda_analogue: "FDA Sentinel-eligible drug utilisation analysis",
+        submission_obligations: [
+            "ENCePP registration encouraged but not mandatory.",
+            "Final report submission per local jurisdiction requirements.",
+        ],
+    },
+    active_surveillance_registry: {
+        gvp_module: "VIII",
+        encepp_protocol_template: "ENCePP-REG-001",
+        rmp_implications: [
+            "Registry serves as data source for ongoing PV signal detection in RMP Part III.",
+        ],
+        fda_analogue: "FDA Sentinel / FAERS-linked registry",
+        submission_obligations: [
+            "Annual registry status report.",
+            "Periodic data linkages reported via PSUR.",
+        ],
+    },
+    pregnancy_registry: {
+        gvp_module: "VIII",
+        encepp_protocol_template: "ENCePP-PREG-001",
+        rmp_implications: [
+            "Pregnancy registry is a standard RMP commitment for teratogenic-risk drugs (Annex 4).",
+            "Outcomes feed into the Pregnancy section of every PSUR.",
+        ],
+        fda_analogue: "FDA Pregnancy Exposure Registry",
+        submission_obligations: [
+            "ENCePP and EUPAS registration.",
+            "Annual or biennial enrolment + outcomes reports to PRAC.",
+            "FDA pregnancy-registry standards apply when US is in scope.",
+        ],
+    },
+    spontaneous_reporting_only: {
+        gvp_module: "VI",
+        rmp_implications: [
+            "Spontaneous reporting is the baseline PV obligation under GVP Module VI; not a designed study.",
+        ],
+        fda_analogue: "FDA FAERS",
+        submission_obligations: [
+            "ICSR submission to EudraVigilance per Module VI timelines.",
+            "PSUR cycle compliance.",
+        ],
+    },
+    ICH_E2E_pharmacovigilance_plan: {
+        gvp_module: "V",
+        rmp_implications: [
+            "Pre-authorisation PV planning per ICH E2E feeds directly into the initial RMP submitted at MAA.",
+        ],
+        fda_analogue: "FDA premarket Pharmacovigilance Plan (per 21 CFR 314.81)",
+        submission_obligations: [
+            "PV plan included in module 1.8.2 of the MAA dossier.",
+            "Conversion to full RMP at MA grant.",
+        ],
+    },
+    not_pv_study: {
+        gvp_module: "VIII",
+        rmp_implications: [
+            "Study does not qualify as a pharmacovigilance study under EMA GVP definitions.",
+        ],
+        fda_analogue: "n/a",
+        submission_obligations: [
+            "No PV-specific submission obligations identified.",
+        ],
+    },
+};
+export function gvpFor(category) {
+    return CATEGORY_MAPPING[category];
+}
+//# sourceMappingURL=gvpModules.js.map

package/dist/pv/gvpModules.js.map ADDED Viewed

@@ -0,0 +1 @@

+ {"version":3,"file":"gvpModules.js","sourceRoot":"","sources":["../../src/pv/gvpModules.ts"],"names":[],"mappings":"AASA,MAAM,CAAC,MAAM,YAAY,GAAG,OAAgB,CAAC;AAU7C,MAAM,CAAC,MAAM,gBAAgB,GAAwC;IACnE,YAAY,EAAE;QACZ,UAAU,EAAE,MAAM;QAClB,wBAAwB,EAAE,iBAAiB;QAC3C,gBAAgB,EAAE;YAChB,sEAAsE;YACtE,+DAA+D;SAChE;QACD,YAAY,EAAE,0CAA0C;QACxD,sBAAsB,EAAE;YACtB,6EAA6E;YAC7E,8CAA8C;YAC9C,wDAAwD;SACzD;KACF;IACD,cAAc,EAAE;QACd,UAAU,EAAE,MAAM;QAClB,wBAAwB,EAAE,iBAAiB;QAC3C,gBAAgB,EAAE;YAChB,qDAAqD;YACrD,gEAAgE;SACjE;QACD,YAAY,EAAE,oCAAoC;QAClD,sBAAsB,EAAE;YACtB,wDAAwD;YACxD,4CAA4C;SAC7C;KACF;IACD,IAAI,EAAE;QACJ,UAAU,EAAE,MAAM;QAClB,wBAAwB,EAAE,iBAAiB;QAC3C,gBAAgB,EAAE;YAChB,sFAAsF;SACvF;QACD,YAAY,EAAE,kDAAkD;QAChE,sBAAsB,EAAE;YACtB,mDAAmD;YACnD,4CAA4C;SAC7C;KACF;IACD,iBAAiB,EAAE;QACjB,UAAU,EAAE,GAAG;QACf,wBAAwB,EAAE,gBAAgB;QAC1C,gBAAgB,EAAE;YAChB,+DAA+D;YAC/D,+CAA+C;SAChD;QACD,YAAY,EAAE,2BAA2B;QACzC,sBAAsB,EAAE;YACtB,iDAAiD;YACjD,kCAAkC;SACnC;KACF;IACD,GAAG,EAAE;QACH,UAAU,EAAE,iBAAiB;QAC7B,wBAAwB,EAAE,gBAAgB;QAC1C,gBAAgB,EAAE;YAChB,4EAA4E;SAC7E;QACD,YAAY,EAAE,iDAAiD;QAC/D,sBAAsB,EAAE;YACtB,mDAAmD;YACnD,8DAA8D;SAC/D;KACF;IACD,4BAA4B,EAAE;QAC5B,UAAU,EAAE,MAAM;QAClB,wBAAwB,EAAE,gBAAgB;QAC1C,gBAAgB,EAAE;YAChB,iFAAiF;SAClF;QACD,YAAY,EAAE,sCAAsC;QACpD,sBAAsB,EAAE;YACtB,gCAAgC;YAChC,2CAA2C;SAC5C;KACF;IACD,kBAAkB,EAAE;QAClB,UAAU,EAAE,MAAM;QAClB,wBAAwB,EAAE,iBAAiB;QAC3C,gBAAgB,EAAE;YAChB,uFAAuF;YACvF,yDAAyD;SAC1D;QACD,YAAY,EAAE,iCAAiC;QAC/C,sBAAsB,EAAE;YACtB,gCAAgC;YAChC,0DAA0D;YAC1D,6DAA6D;SAC9D;KACF;IACD,0BAA0B,EAAE;QAC1B,UAAU,EAAE,IAAI;QAChB,gBAAgB,EAAE;YAChB,gGAAgG;SACjG;QACD,YAAY,EAAE,WAAW;QACzB,sBAAsB,EAAE;YACtB,4DAA4D;YAC5D,wBAAwB;SACzB;KACF;IACD,8BAA8B,EAAE;QAC9B,UAAU,EAAE,GAAG;QACf,gBAAgB,EAAE;YAChB,iGAAiG;SAClG;QACD,YAAY,EAAE,0DAA0D;QACxE,sBAAsB,EAAE;YACtB,sDAAsD;YACtD,qCAAqC;SACtC;KACF;IACD,YAAY,EAAE;QACZ,UAAU,EAAE,MAAM;QAClB,gBAAgB,EAAE;YAChB,gFAAgF;SACjF;QACD,YAAY,EAAE,KAAK;QACnB,sBAAsB,EAAE;YACtB,mDAAmD;SACpD;KACF;CACF,CAAC;AAEF,MAAM,UAAU,MAAM,CAAC,QAAoB;IACzC,OAAO,gBAAgB,CAAC,QAAQ,CAAC,CAAC;AACpC,CAAC"}

package/dist/pv/types.d.ts ADDED Viewed

@@ -0,0 +1,27 @@
+export type PvCategory = "PASS_imposed" | "PASS_voluntary" | "PAES" | "RMP_Annex_4_study" | "DUS" | "active_surveillance_registry" | "pregnancy_registry" | "spontaneous_reporting_only" | "ICH_E2E_pharmacovigilance_plan" | "not_pv_study";
+export type GvpModule = "V" | "VI" | "VIII" | "VIII_Addendum_I";
+export type Jurisdiction = "eu" | "us" | "uk" | "japan" | "china";
+export interface PvClassification {
+    primary_category: PvCategory;
+    alternatives: PvCategory[];
+    gvp_module: GvpModule;
+    gvp_revision: "rev_4";
+    encepp_protocol_template?: string;
+    rmp_implications: string[];
+    fda_analogue?: string;
+    submission_obligations: string[];
+    rationale: string;
+}
+export interface PvClassifyInput {
+    drug: string;
+    indication: string;
+    study_design: "rct" | "single_arm" | "prospective_cohort" | "retrospective_cohort" | "case_control" | "registry" | "spontaneous_reports" | "drug_utilization" | "clinical_trial_extension" | "real_world_evidence";
+    primary_objective: "safety" | "efficacy" | "effectiveness" | "drug_utilization" | "natural_history" | "risk_minimisation_evaluation";
+    regulatory_context: "pre_authorisation" | "post_authorisation" | "conditional_approval" | "accelerated_approval" | "rmp_commitment";
+    imposed_by_authority: boolean;
+    population_includes_pregnant: boolean;
+    population_includes_paediatric: boolean;
+    multi_country: boolean;
+    jurisdictions: Jurisdiction[];
+}
+//# sourceMappingURL=types.d.ts.map

package/dist/pv/types.d.ts.map ADDED Viewed

@@ -0,0 +1 @@

+ {"version":3,"file":"types.d.ts","sourceRoot":"","sources":["../../src/pv/types.ts"],"names":[],"mappings":"AAAA,MAAM,MAAM,UAAU,GAClB,cAAc,GACd,gBAAgB,GAChB,MAAM,GACN,mBAAmB,GACnB,KAAK,GACL,8BAA8B,GAC9B,oBAAoB,GACpB,4BAA4B,GAC5B,gCAAgC,GAChC,cAAc,CAAC;AAEnB,MAAM,MAAM,SAAS,GAAG,GAAG,GAAG,IAAI,GAAG,MAAM,GAAG,iBAAiB,CAAC;AAEhE,MAAM,MAAM,YAAY,GAAG,IAAI,GAAG,IAAI,GAAG,IAAI,GAAG,OAAO,GAAG,OAAO,CAAC;AAElE,MAAM,WAAW,gBAAgB;IAC/B,gBAAgB,EAAE,UAAU,CAAC;IAC7B,YAAY,EAAE,UAAU,EAAE,CAAC;IAC3B,UAAU,EAAE,SAAS,CAAC;IACtB,YAAY,EAAE,OAAO,CAAC;IACtB,wBAAwB,CAAC,EAAE,MAAM,CAAC;IAClC,gBAAgB,EAAE,MAAM,EAAE,CAAC;IAC3B,YAAY,CAAC,EAAE,MAAM,CAAC;IACtB,sBAAsB,EAAE,MAAM,EAAE,CAAC;IACjC,SAAS,EAAE,MAAM,CAAC;CACnB;AAED,MAAM,WAAW,eAAe;IAC9B,IAAI,EAAE,MAAM,CAAC;IACb,UAAU,EAAE,MAAM,CAAC;IACnB,YAAY,EACR,KAAK,GACL,YAAY,GACZ,oBAAoB,GACpB,sBAAsB,GACtB,cAAc,GACd,UAAU,GACV,qBAAqB,GACrB,kBAAkB,GAClB,0BAA0B,GAC1B,qBAAqB,CAAC;IAC1B,iBAAiB,EACb,QAAQ,GACR,UAAU,GACV,eAAe,GACf,kBAAkB,GAClB,iBAAiB,GACjB,8BAA8B,CAAC;IACnC,kBAAkB,EACd,mBAAmB,GACnB,oBAAoB,GACpB,sBAAsB,GACtB,sBAAsB,GACtB,gBAAgB,CAAC;IACrB,oBAAoB,EAAE,OAAO,CAAC;IAC9B,4BAA4B,EAAE,OAAO,CAAC;IACtC,8BAA8B,EAAE,OAAO,CAAC;IACxC,aAAa,EAAE,OAAO,CAAC;IACvB,aAAa,EAAE,YAAY,EAAE,CAAC;CAC/B"}

package/dist/pv/types.js ADDED Viewed

	@@ -0,0 +1,2 @@
1	+ export {};
2	+ //# sourceMappingURL=types.js.map

package/dist/pv/types.js.map ADDED Viewed

	@@ -0,0 +1 @@
1	+ {"version":3,"file":"types.js","sourceRoot":"","sources":["../../src/pv/types.ts"],"names":[],"mappings":""}

package/dist/server.js CHANGED Viewed

@@ -26,6 +26,8 @@ import { handleValidateLinks, validateLinksToolSchema, } from "./tools/validateL
 import { handleUtilityValueSet, utilityValueSetToolSchema, } from "./tools/utilityValueSet.js";
 import { handleItcFeasibility, itcFeasibilityToolSchema, } from "./tools/itcFeasibility.js";
 import { handleExamples, examplesToolSchema } from "./tools/examples.js";
+import { handleMaicWorkflow, maicWorkflowToolSchema, } from "./tools/maicWorkflow.js";
+import { handlePvClassify, pvClassifyToolSchema } from "./tools/pvClassify.js";
 import { randomUUID } from "node:crypto";
 import { trackToolCall, trackSession, shutdownAnalytics, inferSurface, } from "./analytics.js";
 import { createServer } from "node:http";
@@ -156,6 +158,8 @@ function createMcpServer(surfaceRef = { value: "direct_mcp" }, sessionIdRef = {
             utilityValueSetToolSchema,
             itcFeasibilityToolSchema,
             examplesToolSchema,
+            maicWorkflowToolSchema,
+            pvClassifyToolSchema,
         ],
     }));
     server.setRequestHandler(CallToolRequestSchema, async (request) => {
@@ -218,6 +222,12 @@ function createMcpServer(surfaceRef = { value: "direct_mcp" }, sessionIdRef = {
                 case "examples":
                     result = await handleExamples(args);
                     break;
+                case "workflow.maic":
+                    result = await handleMaicWorkflow(args);
+                    break;
+                case "pv.classify":
+                    result = await handlePvClassify(args);
+                    break;
                 default:
                     trackToolCall(name, Date.now() - callStart, "error", sessionIdRef.value || undefined, {
                         surface: surfaceRef.value,

package/dist/server.js.map CHANGED Viewed

	@@ -1 +1 @@
1	- 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