{"id":25039,"date":"2026-11-02T08:54:16","date_gmt":"2026-11-02T07:54:16","guid":{"rendered":"https:\/\/www.mathsly.it\/wordpress\/?page_id=25039"},"modified":"2026-11-02T09:08:46","modified_gmt":"2026-11-02T08:08:46","slug":"pre-submission-statistical-audit","status":"publish","type":"page","link":"https:\/\/www.mathsly.it\/wordpress\/pre-submission-statistical-audit\/","title":{"rendered":"Pre-submission Statistical Audit"},"content":{"rendered":"\n<!-- ============================================================\n  MATHSLY RESEARCH \u2014 Pre-submission Statistical Audit\n  Review indipendente pre-submission per pharma e medical devices\n  Template: mbio (stessa struttura pagina biostatistica)\n============================================================ -->\n\n<link rel=\"preconnect\" href=\"https:\/\/fonts.googleapis.com\">\n<link rel=\"preconnect\" href=\"https:\/\/fonts.gstatic.com\" crossorigin=\"\">\n<link href=\"https:\/\/fonts.googleapis.com\/css2?family=Fraunces:ital,opsz,wght@0,9..144,400;0,9..144,600;0,9..144,700;1,9..144,400;1,9..144,600;1,9..144,700&#038;family=DM+Sans:wght@300;400;500;600&#038;display=swap\" rel=\"stylesheet\">\n\n<style>\n.mpa *, .mpa *::before, .mpa *::after { box-sizing: border-box; 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}\n  .mpa-s5-wrap { padding: 60px 5vw; flex-direction: column !important; gap: 40px; }\n  .mpa-s5-divider { display: none; }\n  .mpa-kpi { padding: 16px 5vw; }\n  .mpa-svc-grid, .mpa-svc-grid.two, .mpa-ctx-grid { grid-template-columns: 1fr; }\n}\n<\/style>\n\n<div class=\"mpa\">\n\n  <p class=\"mpa-geo-text\">Mathsly Research offre il Pre-submission Statistical Audit: una review indipendente delle analisi statistiche prima della submission regolatoria a EMA, FDA o enti notificati. Identifica debolezze metodologiche, gap di documentazione e criticit\u00e0 che i reviewer potrebbero sollevare \u2014 prima che le sollevino loro. Report scritto con criticit\u00e0 classificate per priorit\u00e0. Biostatistico qualificato, H-index 13 Scopus.<\/p>\n\n  <!-- HERO -->\n  <section class=\"mpa-s1\">\n    <div class=\"mpa-s1-bar\"><\/div>\n    <div class=\"mpa-s1-glow a\"><\/div>\n    <div class=\"mpa-s1-glow b\"><\/div>\n    <div class=\"mpa-s1-wrap\">\n      <div>\n        <div class=\"mpa-eyebrow light mpa-reveal\">Regulatory Accountability<\/div>\n        <h1 class=\"mpa-title hero mpa-s1-title mpa-lcp\">Trova i problemi <em>prima del reviewer.<\/em><\/h1>\n        <p class=\"mpa-s1-sub mpa-reveal d1\">Una review indipendente delle analisi statistiche prima della submission a EMA, FDA o a un ente notificato. Mathsly Research esamina il piano analitico, i risultati e la loro presentazione \u2014 identificando le criticit\u00e0 che un reviewer potrebbe sollevare, prima che le sollevino loro.<\/p>\n        <div class=\"mpa-s1-btns mpa-reveal d2\">\n          <button class=\"mpa-btn solid\" data-mly-modal=\"cta\">Richiedi l&#8217;audit<\/button>\n          <a class=\"mpa-btn outline-white\" href=\"https:\/\/www.mathsly.it\/wordpress\/prenotazione-appuntamento\/\">Prenota una call \u2192<\/a>\n        <\/div>\n      <\/div>\n      <div class=\"mpa-diff-list mpa-reveal d1\">\n        <div class=\"mpa-diff-item\">\n          <div class=\"mpa-diff-ico\">&#x1f50d;<\/div>\n          <div>\n            <div class=\"mpa-diff-name\">Prospettiva del reviewer, non del team che ha condotto le analisi<\/div>\n            <div class=\"mpa-diff-desc\">Chi ha prodotto le analisi non vede i propri punti ciechi. Un audit esterno replica lo sguardo critico dell&#8217;ente regolatorio.<\/div>\n          <\/div>\n        <\/div>\n        <div class=\"mpa-diff-item\">\n          <div class=\"mpa-diff-ico\">&#x1f4cb;<\/div>\n          <div>\n            <div class=\"mpa-diff-name\">Report con criticit\u00e0 classificate per priorit\u00e0<\/div>\n            <div class=\"mpa-diff-desc\">Non una lista di osservazioni: un documento operativo che dice cosa blocca la submission, cosa va rafforzato e cosa \u00e8 accettabile cos\u00ec com&#8217;\u00e8.<\/div>\n          <\/div>\n        <\/div>\n        <div class=\"mpa-diff-item\">\n          <div class=\"mpa-diff-ico\">&#x23f1;&#xfe0f;<\/div>\n          <div>\n            <div class=\"mpa-diff-name\">Tempi compatibili con le deadline regolatorie<\/div>\n            <div class=\"mpa-diff-desc\">Consegna in 7\u201314 giorni lavorativi. Percorso urgente disponibile in 3\u20135 giorni per submission imminenti.<\/div>\n          <\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- KPI BAR -->\n  <div class=\"mpa-kpi\">\n    <div class=\"mpa-kpi-inner\">\n      <div class=\"mpa-kpi-item\"><div class=\"mpa-kpi-val\">7\u201314 giorni \u00b7 3\u20135 in urgenza<\/div><div class=\"mpa-kpi-label\">Consegna del report di audit<\/div><\/div>\n      <div class=\"mpa-kpi-item\"><div class=\"mpa-kpi-val\">EMA \u00b7 FDA \u00b7 Enti Notificati<\/div><div class=\"mpa-kpi-label\">Standard di riferimento<\/div><\/div>\n      <div class=\"mpa-kpi-item\"><div class=\"mpa-kpi-val\">Criticit\u00e0 classificate<\/div><div class=\"mpa-kpi-label\">Alta \/ media \/ bassa priorit\u00e0<\/div><\/div>\n      <div class=\"mpa-kpi-item\"><div class=\"mpa-kpi-val\">Report firmato<\/div><div class=\"mpa-kpi-label\">Allegabile al dossier regolatorio<\/div><\/div>\n    <\/div>\n  <\/div>\n\n  <!-- COS'\u00c8 -->\n  <section class=\"mpa-s2\">\n    <div class=\"mpa-s2-wrap\">\n      <div class=\"mpa-s2-left mpa-reveal\">\n        <div class=\"mpa-eyebrow\">Cos&#8217;\u00e8 questo servizio<\/div>\n        <h2 class=\"mpa-title lg\">L&#8217;audit che un reviewer avrebbe <em>fatto su di te.<\/em><\/h2>\n        <p>Ogni submission regolatoria viene esaminata da biostatistici esperti che cercano attivamente debolezze metodologiche. La domanda non \u00e8 se troveranno qualcosa \u2014 \u00e8 se lo trovi tu prima di loro, quando hai ancora il tempo per correggerlo.<\/p>\n        <p>Il Pre-submission Statistical Audit \u00e8 una review indipendente condotta con gli stessi criteri che applicano i reviewer EMA, FDA e gli enti notificati MDR\/IVDR. L&#8217;output non \u00e8 un parere generico: \u00e8 un report operativo con le criticit\u00e0 classificate per priorit\u00e0 e le raccomandazioni su come risolverle prima della submission.<\/p>\n      <\/div>\n      <div class=\"mpa-method-cards\">\n        <div class=\"mpa-method-card mpa-reveal\">\n          <div class=\"mpa-method-ico\">&#x1f4d0;<\/div>\n          <div>\n            <div class=\"mpa-method-title\">Coerenza tra SAP e analisi condotte<\/div>\n            <p class=\"mpa-method-desc\">La prima cosa che verifica un reviewer EMA \u00e8 se le analisi effettivamente eseguite corrispondono a quelle pre-specificate nel SAP. Le deviazioni non documentate sono una delle criticit\u00e0 pi\u00f9 frequenti e pi\u00f9 evitabili.<\/p>\n          <\/div>\n        <\/div>\n        <div class=\"mpa-method-card mpa-reveal d1\">\n          <div class=\"mpa-method-ico\">&#x26a0;&#xfe0f;<\/div>\n          <div>\n            <div class=\"mpa-method-title\">Debolezze metodologiche e gap di documentazione<\/div>\n            <p class=\"mpa-method-desc\">Scelte analitiche non giustificate, gestione dei missing data non documentata, analisi di sensibilit\u00e0 mancanti \u2014 identificate prima che diventino obiezioni formali.<\/p>\n          <\/div>\n        <\/div>\n        <div class=\"mpa-method-card mpa-reveal d2\">\n          <div class=\"mpa-method-ico\">&#x1f4ca;<\/div>\n          <div>\n            <div class=\"mpa-method-title\">Robustezza dei risultati primari e secondari<\/div>\n            <p class=\"mpa-method-desc\">I risultati reggono alle sensitivity analysis? I claim sono supportati dall&#8217;analisi primaria pre-specificata o da analisi esploratorie? La distinzione \u00e8 critica per i reviewer.<\/p>\n          <\/div>\n        <\/div>\n        <div class=\"mpa-method-card mpa-reveal d3\">\n          <div class=\"mpa-method-ico\">&#x1f4dd;<\/div>\n          <div>\n            <div class=\"mpa-method-title\">Qualit\u00e0 della presentazione statistica<\/div>\n            <p class=\"mpa-method-desc\">Tabelle, figure e narrative statistiche vengono valutate per chiarezza, completezza e conformit\u00e0 agli standard ICH E3 e CTD \u2014 perch\u00e9 anche un risultato solido pu\u00f2 essere respinto se mal presentato.<\/p>\n          <\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- COSA ESAMINA L'AUDIT (navy) -->\n  <section class=\"mpa-s3\">\n    <div class=\"mpa-s3-wrap\">\n      <div class=\"mpa-s3-header mpa-reveal\">\n        <div class=\"mpa-eyebrow\" style=\"color:rgba(34,159,164,.70);\">Perimetro dell&#8217;audit<\/div>\n        <h2 class=\"mpa-title lg\">Cosa viene esaminato, <em>concretamente.<\/em><\/h2>\n        <p>Il perimetro viene definito insieme in base ai documenti disponibili e alla fase della submission. Queste sono le aree tipicamente coperte.<\/p>\n      <\/div>\n      <div class=\"mpa-svc-grid\">\n        <div class=\"mpa-svc-card mpa-reveal\">\n          <div class=\"mpa-svc-tag\">Piano Analitico<\/div>\n          <div class=\"mpa-svc-title\">SAP e coerenza con il protocollo<\/div>\n          <ul class=\"mpa-svc-list\">\n            <li>Completezza del SAP rispetto agli endpoint del protocollo<\/li>\n            <li>Pre-specificazione delle analisi primarie e secondarie<\/li>\n            <li>Definizione delle popolazioni (ITT, mITT, PP, safety set)<\/li>\n            <li>Gestione dei missing data e sensitivity analysis pre-specificate<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mpa-svc-card mpa-reveal d1\">\n          <div class=\"mpa-svc-tag\">Analisi Condotte<\/div>\n          <div class=\"mpa-svc-title\">Verifica dell&#8217;esecuzione<\/div>\n          <ul class=\"mpa-svc-list\">\n            <li>Corrispondenza tra analisi eseguite e SAP<\/li>\n            <li>Documentazione delle deviazioni dal piano analitico<\/li>\n            <li>Appropriatezza dei test statistici scelti<\/li>\n            <li>Gestione dell&#8217;alpha spending e aggiustamento per molteplicit\u00e0<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mpa-svc-card mpa-reveal d2\">\n          <div class=\"mpa-svc-tag\">Robustezza<\/div>\n          <div class=\"mpa-svc-title\">Sensitivity e subgroup analysis<\/div>\n          <ul class=\"mpa-svc-list\">\n            <li>Solidit\u00e0 dei risultati primari alle sensitivity analysis<\/li>\n            <li>Analisi dei sottogruppi pre-specificate vs esploratorie<\/li>\n            <li>Tipping point analysis per i risultati critici<\/li>\n            <li>Valutazione dell&#8217;impatto dei missing data sui risultati<\/li>\n          <\/ul>\n        <\/div>\n      <\/div>\n      <div class=\"mpa-svc-grid two\">\n        <div class=\"mpa-svc-card mpa-reveal\">\n          <div class=\"mpa-svc-tag\">Documentazione<\/div>\n          <div class=\"mpa-svc-title\">Presentazione e conformit\u00e0 ICH<\/div>\n          <ul class=\"mpa-svc-list\">\n            <li>Qualit\u00e0 di tabelle, listing e figure (TLF) per il CSR<\/li>\n            <li>Conformit\u00e0 della sezione statistica agli standard ICH E3<\/li>\n            <li>Chiarezza della narrative statistica per i reviewer<\/li>\n            <li>Completezza dei moduli CTD (2.7.3 e relativi)<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mpa-svc-card mpa-reveal d1\">\n          <div class=\"mpa-svc-tag\">Output<\/div>\n          <div class=\"mpa-svc-title\">Report di audit classificato<\/div>\n          <ul class=\"mpa-svc-list\">\n            <li>Criticit\u00e0 alta priorit\u00e0 \u2014 bloccanti per la submission<\/li>\n            <li>Criticit\u00e0 media priorit\u00e0 \u2014 da rafforzare prima di inviare<\/li>\n            <li>Criticit\u00e0 bassa priorit\u00e0 \u2014 accettabili, da documentare<\/li>\n            <li>Raccomandazioni operative per ogni criticit\u00e0 identificata<\/li>\n          <\/ul>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- PER CHI (bianco) -->\n  <section class=\"mpa-s4\">\n    <div class=\"mpa-s4-wrap\">\n      <div class=\"mpa-s4-header mpa-reveal\">\n        <div class=\"mpa-eyebrow\">Per chi \u00e8<\/div>\n        <h2 class=\"mpa-title lg\">I contesti in cui l&#8217;audit <em>fa la differenza.<\/em><\/h2>\n        <p>Il servizio \u00e8 progettato per chi sta per inviare una submission e vuole ridurre il rischio di obiezioni statistiche \u2014 o per chi ha gi\u00e0 ricevuto obiezioni e deve capire dove intervenire.<\/p>\n      <\/div>\n      <div class=\"mpa-ctx-grid\">\n        <div class=\"mpa-ctx-card mpa-reveal\">\n          <div class=\"mpa-ctx-cat\">Pharma \u00b7 Biotech<\/div>\n          <div class=\"mpa-ctx-title\">Submission EMA o FDA in preparazione<\/div>\n          <ul class=\"mpa-ctx-list\">\n            <li>NDA, MAA o sNDA con deadline regolatoria definita<\/li>\n            <li>Trial con analisi condotte internamente o da CRO terza<\/li>\n            <li>Prodotti per i quali la solidit\u00e0 statistica \u00e8 critica per l&#8217;approvazione<\/li>\n            <li>Studi con analisi complesse (adaptive, bayesiani, missing data estensivi)<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mpa-ctx-card mpa-reveal d1\">\n          <div class=\"mpa-ctx-cat\">Medical Devices \u00b7 IVD<\/div>\n          <div class=\"mpa-ctx-title\">Certificazione MDR, IVDR o 510(k)<\/div>\n          <ul class=\"mpa-ctx-list\">\n            <li>Studi di performance clinica per IVDR con analisi statistiche<\/li>\n            <li>Clinical Evaluation Report con sezione statistica da certificare<\/li>\n            <li>Studi di accuratezza diagnostica per 510(k) FDA<\/li>\n            <li>PMCF con analisi statistiche da presentare all&#8217;ente notificato<\/li>\n          <\/ul>\n        <\/div>\n        <div class=\"mpa-ctx-card mpa-reveal d2\">\n          <div class=\"mpa-ctx-cat\">Risposta a obiezioni<\/div>\n          <div class=\"mpa-ctx-title\">Dopo un Day 120 o un Major Objection<\/div>\n          <ul class=\"mpa-ctx-list\">\n            <li>Submission gi\u00e0 inviata con obiezioni statistiche ricevute<\/li>\n            <li>Analisi da rivedere o integrare in risposta al reviewer<\/li>\n            <li>Necessit\u00e0 di capire la radice delle criticit\u00e0 sollevate<\/li>\n            <li>Preparazione della risposta formale con analisi aggiuntive<\/li>\n          <\/ul>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- DELIVERABLE + TEMPISTICHE (navy split) -->\n  <section class=\"mpa-s5\">\n    <div class=\"mpa-s5-glow\"><\/div>\n    <div class=\"mpa-s5-wrap\">\n      <div class=\"mpa-s5-col mpa-reveal\">\n        <div class=\"mpa-eyebrow\">Cosa ricevi<\/div>\n        <h2 class=\"mpa-title lg\">Il report di <em>audit.<\/em><\/h2>\n        <p>Non una lista di commenti: un documento strutturato che puoi usare direttamente per correggere la submission o preparare la risposta alle obiezioni.<\/p>\n        <ul class=\"mpa-check-list\">\n          <li><span class=\"mpa-check-ico\">\u2713<\/span>Executive summary con le criticit\u00e0 pi\u00f9 rilevanti<\/li>\n          <li><span class=\"mpa-check-ico\">\u2713<\/span>Analisi dettagliata per area (SAP, esecuzione, robustezza, documentazione)<\/li>\n          <li><span class=\"mpa-check-ico\">\u2713<\/span>Classificazione di ogni criticit\u00e0 per priorit\u00e0 (alta \/ media \/ bassa)<\/li>\n          <li><span class=\"mpa-check-ico\">\u2713<\/span>Raccomandazione operativa per ogni criticit\u00e0 identificata<\/li>\n          <li><span class=\"mpa-check-ico\">\u2713<\/span>Firma del biostatistico responsabile dell&#8217;audit<\/li>\n          <li><span class=\"mpa-check-ico\">\u2713<\/span>Call di debriefing inclusa \u2014 per discutere il report e pianificare le azioni<\/li>\n        <\/ul>\n      <\/div>\n      <div class=\"mpa-s5-divider\"><\/div>\n      <div class=\"mpa-s5-col mpa-reveal d1\">\n        <div class=\"mpa-eyebrow\">Tempistiche e processo<\/div>\n        <h2 class=\"mpa-title lg\">Dall&#8217;avvio al report in <em>14 giorni.<\/em><\/h2>\n        <p>Il processo \u00e8 progettato per adattarsi alle deadline regolatorie \u2014 incluso un percorso urgente per submission imminenti.<\/p>\n        <ul class=\"mpa-check-list\">\n          <li><span class=\"mpa-check-ico\">1<\/span>Invio dei documenti \u2014 SAP, analisi, TLF, bozza CSR<\/li>\n          <li><span class=\"mpa-check-ico\">2<\/span>Scoping call (30 min) \u2014 definizione del perimetro e delle priorit\u00e0<\/li>\n          <li><span class=\"mpa-check-ico\">3<\/span>Audit indipendente \u2014 7\u201314 giorni lavorativi (3\u20135 in urgenza)<\/li>\n          <li><span class=\"mpa-check-ico\">4<\/span>Consegna del report classificato<\/li>\n          <li><span class=\"mpa-check-ico\">5<\/span>Call di debriefing per discutere le raccomandazioni<\/li>\n          <li><span class=\"mpa-check-ico\">\u2713<\/span>Supporto opzionale nell&#8217;implementazione delle correzioni<\/li>\n        <\/ul>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- FAQ -->\n  <section class=\"mpa-s6\">\n    <div class=\"mpa-s6-wrap\">\n      <div class=\"mpa-s6-left mpa-reveal\">\n        <div class=\"mpa-eyebrow\">FAQ<\/div>\n        <h2 class=\"mpa-title lg\">Domande frequenti sull&#8217;<em>audit.<\/em><\/h2>\n        <p>Le domande pi\u00f9 comuni prima di avviare un pre-submission audit.<\/p>\n        <button class=\"mpa-btn solid\" data-mly-modal=\"cta\">Hai altre domande?<\/button>\n      <\/div>\n      <div class=\"mpa-faq mpa-reveal d1\">\n        <div class=\"mpa-faq-item\">\n          <div class=\"mpa-faq-q\">L&#8217;audit si pu\u00f2 fare anche se le analisi le ha condotte una CRO?<span class=\"mpa-faq-ico\">+<\/span><\/div>\n          <div class=\"mpa-faq-a\">S\u00ec \u2014 anzi, \u00e8 uno dei casi d&#8217;uso pi\u00f9 frequenti. Quando le analisi sono state condotte da una CRO, lo sponsor spesso non ha le competenze interne per valutare criticamente la qualit\u00e0 del lavoro prima di inviarlo. L&#8217;audit fornisce quella valutazione indipendente, senza interferire con il rapporto con la CRO.<\/div>\n        <\/div>\n        <div class=\"mpa-faq-item\">\n          <div class=\"mpa-faq-q\">Cosa succede se l&#8217;audit identifica criticit\u00e0 gravi?<span class=\"mpa-faq-ico\">+<\/span><\/div>\n          <div class=\"mpa-faq-a\">Il report specifica per ogni criticit\u00e0 la sua natura e le opzioni per risolverla. Per le criticit\u00e0 ad alta priorit\u00e0, Mathsly Research pu\u00f2 supportare direttamente l&#8217;implementazione delle correzioni \u2014 nuove analisi, aggiornamento della documentazione, revisione della narrative statistica \u2014 con tempistiche definite in base alla deadline.<\/div>\n        <\/div>\n        <div class=\"mpa-faq-item\">\n          <div class=\"mpa-faq-q\">Quanto materiale serve per avviare l&#8217;audit?<span class=\"mpa-faq-ico\">+<\/span><\/div>\n          <div class=\"mpa-faq-a\">Il minimo indispensabile \u00e8 il SAP e le analisi condotte (output statistici, TLF). Pi\u00f9 materiale \u00e8 disponibile \u2014 protocollo, bozza CSR, codice di analisi \u2014 pi\u00f9 l&#8217;audit \u00e8 completo. Nella scoping call valutiamo cosa \u00e8 disponibile e definiamo il perimetro in base ai documenti esistenti.<\/div>\n        <\/div>\n        <div class=\"mpa-faq-item\">\n          <div class=\"mpa-faq-q\">Il report pu\u00f2 essere condiviso con l&#8217;ente regolatorio?<span class=\"mpa-faq-ico\">+<\/span><\/div>\n          <div class=\"mpa-faq-a\">S\u00ec. Il report \u00e8 un documento professionale firmato, allegabile al dossier come evidenza di due diligence statistica indipendente. In alcuni contesti \u2014 specialmente per medical devices \u2014 documentare che le analisi sono state sottoposte a review esterna pu\u00f2 rafforzare la posizione in fase di valutazione.<\/div>\n        <\/div>\n        <div class=\"mpa-faq-item\">\n          <div class=\"mpa-faq-q\">\u00c8 disponibile un percorso urgente?<span class=\"mpa-faq-ico\">+<\/span><\/div>\n          <div class=\"mpa-faq-a\">S\u00ec. Per submission con deadline ravvicinate \u00e8 disponibile un percorso urgente con consegna in 3\u20135 giorni lavorativi. Richiede che i documenti siano completi e disponibili all&#8217;avvio. Il percorso urgente ha una maggiorazione rispetto alla tariffa standard \u2014 da definire in base al perimetro.<\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- CTA -->\n  <section class=\"mpa-s7\">\n    <div class=\"mpa-s7-wrap\">\n      <div class=\"mpa-eyebrow mpa-reveal\" style=\"justify-content:center; color:rgba(34,159,164,.70);\">Hai una submission in arrivo?<\/div>\n      <h2 class=\"mpa-title lg mpa-reveal d1\">Meglio trovare i problemi adesso che <em>dopo la submission.<\/em><\/h2>\n      <p class=\"mpa-reveal d2\">Inviaci SAP e analisi. Definiamo il perimetro in una call di 30 minuti e partiamo con l&#8217;audit. Il report arriva prima della tua deadline.<\/p>\n      <div class=\"mpa-s7-btns mpa-reveal d2\">\n        <button class=\"mpa-btn solid-light\" data-mly-modal=\"cta\">Richiedi l&#8217;audit<\/button>\n        <a class=\"mpa-btn outline-light\" href=\"https:\/\/www.mathsly.it\/wordpress\/prenotazione-appuntamento\/\">Prenota una call<\/a>\n      <\/div>\n      <div class=\"mpa-related mpa-reveal d3\">\n        <span class=\"mpa-related-label\">Vedi anche<\/span>\n        <a class=\"mpa-related-link\" href=\"https:\/\/www.mathsly.it\/wordpress\/statistical-accountability-partner\/\">Statistical Accountability Partner<\/a>\n        <a class=\"mpa-related-link\" href=\"https:\/\/www.mathsly.it\/wordpress\/statistica-dossier-regolatori\/\">Statistica per Dossier Regolatori<\/a>\n        <a class=\"mpa-related-link\" href=\"https:\/\/www.mathsly.it\/wordpress\/gap-analysis-nuove-indicazioni\/\">Gap Analysis \u2014 Nuove Indicazioni<\/a>\n        <a class=\"mpa-related-link\" href=\"https:\/\/www.mathsly.it\/wordpress\/advisory-metodologico-indipendente\/\">Advisory Indipendente<\/a>\n        <a class=\"mpa-related-link\" href=\"https:\/\/www.mathsly.it\/wordpress\/servizi\/\">Tutti i servizi<\/a>\n      <\/div>\n    <\/div>\n  <\/section>\n\n<\/div>\n\n<script>\n(function(){\n  var io = new IntersectionObserver(function(entries){\n    entries.forEach(function(e){\n      if(e.isIntersecting){ e.target.classList.add(\"up\"); io.unobserve(e.target); }\n    });\n  }, { threshold: 0.07 });\n  document.querySelectorAll(\".mpa-reveal\").forEach(function(el){ io.observe(el); });\n  document.querySelectorAll(\".mpa-faq-item\").forEach(function(item){\n    item.querySelector(\".mpa-faq-q\").addEventListener(\"click\", function(){\n      var isOpen = item.classList.contains(\"open\");\n      document.querySelectorAll(\".mpa-faq-item\").forEach(function(i){ i.classList.remove(\"open\"); });\n      if(!isOpen) item.classList.add(\"open\");\n    });\n  });\n})();\n<\/script>\n","protected":false},"excerpt":{"rendered":"<p>Mathsly Research offre il Pre-submission Statistical Audit: una review indipendente delle analisi statistiche prima della submission regolatoria a EMA, FDA o enti notificati. Identifica debolezze metodologiche, gap di documentazione e criticit\u00e0 che i reviewer potrebbero sollevare \u2014 prima che le sollevino loro. Report scritto con criticit\u00e0 classificate per priorit\u00e0. Biostatistico qualificato, H-index 13 Scopus. Regulatory &#8230; <a title=\"Pre-submission Statistical Audit\" class=\"read-more\" href=\"https:\/\/www.mathsly.it\/wordpress\/pre-submission-statistical-audit\/\" aria-label=\"Per saperne di pi\u00f9 su Pre-submission Statistical Audit\">Leggi tutto<\/a><\/p>\n","protected":false},"author":138,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-25039","page","type-page","status-publish"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.8 (Yoast SEO v28.8) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Pre-submission Statistical Audit - Mathsly Research<\/title>\n<meta name=\"description\" content=\"Revisione statistica indipendente prima della submission a enti regolatori. Identifica criticit\u00e0 metodologiche nel SAP, nelle analisi e nella documentazione prima che le trovi il reviewer. 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