{"id":25047,"date":"2026-11-02T09:00:24","date_gmt":"2026-11-02T08:00:24","guid":{"rendered":"https:\/\/www.mathsly.it\/wordpress\/?page_id=25047"},"modified":"2026-11-02T09:09:31","modified_gmt":"2026-11-02T08:09:31","slug":"regulatory-accountability","status":"publish","type":"page","link":"https:\/\/www.mathsly.it\/wordpress\/regulatory-accountability\/","title":{"rendered":"Regulatory Accountability"},"content":{"rendered":"\n<!-- ============================================================\n  MATHSLY RESEARCH \u2014 Regulatory Accountability Hub\n  Pagina di categoria per i 4 servizi Regulatory Accountability\n  CSS prefix: .mra\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.mra *, .mra *::before, .mra *::after { box-sizing: border-box; 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flex-wrap: wrap; gap: 8px; align-items: center; justify-content: center; padding-top: 32px; border-top: 1px solid var(--border); }\n.mra-related-label { font-size: 11px; font-weight: 600; letter-spacing: .10em; text-transform: uppercase; color: var(--ink-3) !important; margin-right: 4px; }\n.mra-related-link { font-size: 13px; color: var(--ink-2) !important; padding: 6px 14px; border-radius: 100px; border: 1px solid var(--border); transition: border-color .2s, color .2s; text-decoration: none !important; }\n.mra-related-link:hover { border-color: var(--teal) !important; color: var(--teal) !important; }\n\n@media (max-width: 1024px) {\n  .mra-s1-wrap, .mra-s2-wrap { grid-template-columns: 1fr; gap: 48px; }\n  .mra-kpi-item { border-right: none; padding: 0; }\n  .mra-kpi-inner { gap: 16px; }\n}\n@media (max-width: 768px) {\n  .mra-s1-wrap, .mra-s2-wrap, .mra-s3-wrap, .mra-s4-wrap { padding: 60px 5vw; }\n  .mra-kpi { padding: 16px 5vw; }\n  .mra-svc-grid { grid-template-columns: 1fr; }\n}\n<\/style>\n\n<div class=\"mra\">\n\n  <p class=\"mra-geo\">Mathsly Research \u2014 Regulatory Accountability: servizi specializzati per pharma, biotech e medical devices che devono difendere la loro statistica in sede regolatoria. Statistical Accountability Partner, Pre-submission Statistical Audit, Statistica per Dossier Regolatori, Gap Analysis per Nuove Indicazioni. Biostatistico qualificato EMA \u00b7 FDA \u00b7 ICH.<\/p>\n\n  <!-- HERO -->\n  <section class=\"mra-s1\">\n    <div class=\"mra-s1-bar\"><\/div>\n    <div class=\"mra-s1-glow a\"><\/div>\n    <div class=\"mra-s1-glow b\"><\/div>\n    <div class=\"mra-s1-wrap\">\n      <div>\n        <div class=\"mra-eyebrow mra-reveal\" style=\"color:rgba(34,159,164,.75);\">Regulatory Accountability<\/div>\n        <h1 class=\"mra-title hero mra-s1-title mra-lcp\">Statistica che si pu\u00f2 firmare. <em>Metodologia che si pu\u00f2 difendere.<\/em><\/h1>\n        <p class=\"mra-s1-sub mra-reveal d1\">Quattro servizi pensati per chi deve presentare evidenza statistica a EMA, FDA o Enti Notificati \u2014 e sa che un reviewer esperto legger\u00e0 ogni numero. Un biostatistico qualificato a fianco del tuo team, dall&#8217;impostazione alla submission.<\/p>\n        <div class=\"mra-s1-btns mra-reveal d2\">\n          <button class=\"mra-btn solid\" data-mly-modal=\"cta\">Raccontaci il progetto<\/button>\n          <a class=\"mra-btn outline-white\" href=\"https:\/\/www.mathsly.it\/wordpress\/prenotazione-appuntamento\/\">Prenota una call \u2192<\/a>\n        <\/div>\n      <\/div>\n      <div class=\"mra-diff-list mra-reveal d1\">\n        <div class=\"mra-diff-item\">\n          <div class=\"mra-diff-ico\">&#x1f6e1;&#xfe0f;<\/div>\n          <div>\n            <div class=\"mra-diff-name\">Accountability \u00e8 il criterio, non il servizio<\/div>\n            <div class=\"mra-diff-desc\">Non forniamo &#8220;analisi statistiche&#8221;. Forniamo analisi che il tuo team pu\u00f2 firmare e difendere davanti a un comitato etico, a un reviewer EMA o a un panel FDA \u2014 con la documentazione metodologica che lo dimostra.<\/div>\n          <\/div>\n        <\/div>\n        <div class=\"mra-diff-item\">\n          <div class=\"mra-diff-ico\">&#x1f50e;<\/div>\n          <div>\n            <div class=\"mra-diff-name\">La prospettiva del reviewer, prima della submission<\/div>\n            <div class=\"mra-diff-desc\">Ogni servizio \u00e8 progettato per anticipare le domande che un reviewer esperto porr\u00e0 \u2014 sulle scelte del SAP, sulla robustezza delle analisi, sulla coerenza della documentazione ICH.<\/div>\n          <\/div>\n        <\/div>\n        <div class=\"mra-diff-item\">\n          <div class=\"mra-diff-ico\">&#x270d;&#xfe0f;<\/div>\n          <div>\n            <div class=\"mra-diff-name\">Ogni output \u00e8 firmato<\/div>\n            <div class=\"mra-diff-desc\">Report, SAP, audit e gap analysis portano la firma del biostatistico responsabile. Non un documento anonimo \u2014 un documento attribuibile, con un metodologo che risponde del suo contenuto.<\/div>\n          <\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- KPI BAR -->\n  <div class=\"mra-kpi\">\n    <div class=\"mra-kpi-inner\">\n      <div class=\"mra-kpi-item\"><div class=\"mra-kpi-val\">4 servizi<\/div><div class=\"mra-kpi-label\">Copertura del ciclo regolatorio<\/div><\/div>\n      <div class=\"mra-kpi-item\"><div class=\"mra-kpi-val\">EMA \u00b7 FDA \u00b7 Enti Notificati<\/div><div class=\"mra-kpi-label\">Standard regolatori di riferimento<\/div><\/div>\n      <div class=\"mra-kpi-item\"><div class=\"mra-kpi-val\">ICH E9 \u00b7 E9(R1) \u00b7 E3 \u00b7 CTD<\/div><div class=\"mra-kpi-label\">Linee guida ICH coperte<\/div><\/div>\n      <div class=\"mra-kpi-item\"><div class=\"mra-kpi-val\">Firmato dal biostatistico<\/div><div class=\"mra-kpi-label\">Ogni output \u00e8 attribuibile<\/div><\/div>\n    <\/div>\n  <\/div>\n\n  <!-- INTRO -->\n  <section class=\"mra-s2\">\n    <div class=\"mra-s2-wrap\">\n      <div class=\"mra-s2-left mra-reveal\">\n        <div class=\"mra-eyebrow\">Perch\u00e9 Regulatory Accountability<\/div>\n        <h2 class=\"mra-title lg\">Quando la statistica <em>deve reggere alla review.<\/em><\/h2>\n        <p>Ci sono due tipi di analisi statistiche nella ricerca clinica e regolatoria: quelle che producono un numero, e quelle che producono un&#8217;evidenza difendibile. La differenza non sta nel software \u2014 sta nella qualit\u00e0 della pre-specificazione, nella coerenza tra protocollo e analisi, e nella documentazione che accompagna ogni scelta metodologica.<\/p>\n        <p>I servizi Regulatory Accountability di Mathsly Research sono costruiti attorno a questa differenza. Non perch\u00e9 sia un valore aggiunto \u2014 ma perch\u00e9 \u00e8 il requisito minimo per presentarsi davanti a EMA, FDA o a un Ente Notificato con qualcosa che regge.<\/p>\n      <\/div>\n      <div class=\"mra-when-cards\">\n        <div class=\"mra-when-card mra-reveal\">\n          <div class=\"mra-when-ico\">&#x1f4cb;<\/div>\n          <div>\n            <div class=\"mra-when-title\">Submission a EMA o FDA in preparazione<\/div>\n            <p class=\"mra-when-desc\">Il momento in cui la qualit\u00e0 della documentazione statistica diventa visibile \u2014 e le lacune metodologiche diventano Major Objections. Prima \u00e8 meglio.<\/p>\n          <\/div>\n        <\/div>\n        <div class=\"mra-when-card mra-reveal d1\">\n          <div class=\"mra-when-ico\">&#x1f5c2;&#xfe0f;<\/div>\n          <div>\n            <div class=\"mra-when-title\">Dossier tecnico per certificazione MDR o IVDR<\/div>\n            <p class=\"mra-when-desc\">Il reviewer dell&#8217;Ente Notificato valuter\u00e0 ogni numero nel CER e nel PMCF. La validazione statistica del piano non \u00e8 opzionale \u2014 \u00e8 parte del dossier.<\/p>\n          <\/div>\n        <\/div>\n        <div class=\"mra-when-card mra-reveal d2\">\n          <div class=\"mra-when-ico\">&#x1f52c;<\/div>\n          <div>\n            <div class=\"mra-when-title\">Studio in corso senza biostatistico nel team<\/div>\n            <p class=\"mra-when-desc\">Un programma di sviluppo pluriennale richiede coerenza metodologica nel tempo. Il Statistical Accountability Partner garantisce continuit\u00e0 senza i costi di una posizione interna.<\/p>\n          <\/div>\n        <\/div>\n        <div class=\"mra-when-card mra-reveal d3\">\n          <div class=\"mra-when-ico\">&#x1f5fa;&#xfe0f;<\/div>\n          <div>\n            <div class=\"mra-when-title\">Nuova indicazione in valutazione<\/div>\n            <p class=\"mra-when-desc\">Prima di avviare nuovi trial costosi, vale la pena sapere cosa possono gi\u00e0 dimostrare i dati esistenti \u2014 e se il gap \u00e8 colmabile con analisi secondarie ben pre-specificate.<\/p>\n          <\/div>\n        <\/div>\n      <\/div>\n    <\/div>\n  <\/section>\n\n  <!-- SERVIZI (navy) -->\n  <section class=\"mra-s3\">\n    <div class=\"mra-s3-wrap\">\n      <div class=\"mra-s3-header mra-reveal\">\n        <div class=\"mra-eyebrow\" style=\"color:rgba(34,159,164,.70);\">I quattro servizi<\/div>\n        <h2 class=\"mra-title lg\">Quattro servizi, <em>un unico principio.<\/em><\/h2>\n        <p>Ogni servizio risponde a una fase specifica del ciclo regolatorio \u2014 e pu\u00f2 essere richiesto singolarmente o in combinazione, con un unico biostatistico che garantisce la coerenza metodologica lungo tutto il programma.<\/p>\n      <\/div>\n      <div class=\"mra-svc-grid\">\n        <a class=\"mra-svc-card mra-reveal\" href=\"https:\/\/www.mathsly.it\/wordpress\/statistical-accountability-partner\/\">\n          <div class=\"mra-svc-tag\">Continuit\u00e0 \u00b7 Retainer<\/div>\n          <div class=\"mra-svc-title\">Statistical Accountability Partner<\/div>\n          <div class=\"mra-svc-desc\">Un biostatistico qualificato a fianco del tuo team ogni mese \u2014 per review delle analisi, validazione delle scelte metodologiche, supporto alle decisioni statistiche e risposta alle richieste degli enti regolatori. Fee mensile, disponibilit\u00e0 garantita.<\/div>\n          <div class=\"mra-svc-footer\">\n            <div class=\"mra-svc-price\">Da <strong>2.500\u20ac\/mese<\/strong><\/div>\n            <div class=\"mra-svc-arr\">Scopri il servizio \u2192<\/div>\n          <\/div>\n        <\/a>\n        <a class=\"mra-svc-card mra-reveal d1\" href=\"https:\/\/www.mathsly.it\/wordpress\/pre-submission-statistical-audit\/\">\n          <div class=\"mra-svc-tag\">Pre-submission \u00b7 Audit<\/div>\n          <div class=\"mra-svc-title\">Pre-submission Statistical Audit<\/div>\n          <div class=\"mra-svc-desc\">Revisione statistica indipendente dell&#8217;intero pacchetto analitico prima della submission \u2014 con la prospettiva di un reviewer EMA o FDA. Identifica criticit\u00e0 nel SAP, nelle analisi e nella documentazione ICH prima che le trovi l&#8217;ente. Report classificato, firmato.<\/div>\n          <div class=\"mra-svc-footer\">\n            <div class=\"mra-svc-price\">Da <strong>4.500\u20ac<\/strong><\/div>\n            <div class=\"mra-svc-arr\">Scopri il servizio \u2192<\/div>\n          <\/div>\n        <\/a>\n        <a class=\"mra-svc-card mra-reveal\" href=\"https:\/\/www.mathsly.it\/wordpress\/statistica-dossier-regolatori\/\">\n          <div class=\"mra-svc-tag\">Documentazione \u00b7 ICH<\/div>\n          <div class=\"mra-svc-title\">Statistica per Dossier Regolatori<\/div>\n          <div class=\"mra-svc-desc\">Redazione e revisione di SAP (ICH E9\/E9R1), sezioni statistiche del CSR (ICH E3) e modulo CTD 2.7.3. Documentazione firmata dal biostatistico, pronta per submission a EMA, FDA e Enti Notificati. 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Statistical Accountability Partner, Pre-submission Statistical Audit, Statistica per Dossier Regolatori, Gap Analysis per Nuove Indicazioni. Biostatistico qualificato EMA \u00b7 FDA \u00b7 ICH. Regulatory Accountability Statistica che si pu\u00f2 firmare. Metodologia che si pu\u00f2 &#8230; <a title=\"Regulatory Accountability\" class=\"read-more\" href=\"https:\/\/www.mathsly.it\/wordpress\/regulatory-accountability\/\" aria-label=\"Per saperne di pi\u00f9 su Regulatory Accountability\">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-25047","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>Regulatory Accountability | Biostatistico per Submission EMA FDA - Mathsly Research<\/title>\n<meta name=\"description\" content=\"Quattro servizi di biostatistica regolatoria per pharma, biotech e medical devices. Statistical Accountability Partner, audit pre-submission, documentazione ICH e gap analysis. 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