{"id":129,"date":"2025-08-07T16:53:04","date_gmt":"2025-08-07T14:53:04","guid":{"rendered":"https:\/\/testwp.marcocammarata.it\/?page_id=129"},"modified":"2026-01-21T12:03:00","modified_gmt":"2026-01-21T11:03:00","slug":"start-up","status":"publish","type":"page","link":"https:\/\/www.we4cr.com\/it\/solutions\/start-up\/","title":{"rendered":"Start Up"},"content":{"rendered":"<div class=\"wp-block-group alignfull is-style-default has-tertiary-background-color has-background has-global-padding is-content-justification-center is-layout-constrained wp-container-core-group-is-layout-d491b7b6 wp-block-group-is-layout-constrained\" style=\"padding-top:var(--wp--preset--spacing--xx-large);padding-bottom:var(--wp--preset--spacing--xx-large)\">\n<p class=\"has-text-align-center has-primary-color has-text-color has-base-font-size wp-block-paragraph\" style=\"font-style:normal;font-weight:600\">Per fase del progetto<\/p>\n\n\n\n<h1 class=\"wp-block-heading has-text-align-center has-large-font-size\">START UP<\/h1>\n\n\n\n<p class=\"has-text-align-center has-small-font-size wp-block-paragraph translation-block\">La <strong>fase Start-up<\/strong> \u00e8 dove i piani diventano azione. \nDall'ottenere le <strong>approvazioni<\/strong> alla preparazione dei \n<strong>siti<\/strong> per il reclutamento, coordiniamo ogni passo \naffinch\u00e9 il trial parta su basi solide. \nIl nostro team gestisce submission, <strong>site onboarding<\/strong>, \n<strong>negoziazioni contrattuali<\/strong> e logistica prodotti \ncon precisione e <strong>conformit\u00e0<\/strong> al primo posto. \nTutto per una transizione fluida al <strong>reclutamento pazienti<\/strong>.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-group alignfull feature-boxes has-global-padding is-layout-constrained wp-container-core-group-is-layout-ee2d0291 wp-block-group-is-layout-constrained\" style=\"margin-top:0px;padding-top:var(--wp--preset--spacing--x-large);padding-right:var(--wp--preset--spacing--large);padding-bottom:var(--wp--preset--spacing--x-large);padding-left:var(--wp--preset--spacing--large)\">\n<div class=\"wp-block-gutena-tabs alignwide gutena-tabs-block gutena-tabs-block-76a238-12\"><ul class=\"gutena-tabs-tab tab-flex\"><li class=\"gutena-tab-title active\" data-tab=\"1\"><div class=\"gutena-tab-title-content icon-left\"><div class=\"gutena-tab-title-text\"><div><strong>Documenti<\/strong><\/div><\/div><\/div><\/li><li class=\"gutena-tab-title inactive\" data-tab=\"2\"><div class=\"gutena-tab-title-content icon-left\"><div class=\"gutena-tab-title-text\"><div>Contratti<\/div><\/div><\/div><\/li><li class=\"gutena-tab-title inactive\" data-tab=\"3\"><div class=\"gutena-tab-title-content icon-left\"><div class=\"gutena-tab-title-text\"><div><strong>Formazione<\/strong><\/div><\/div><\/div><\/li><li class=\"gutena-tab-title inactive\" data-tab=\"4\"><div class=\"gutena-tab-title-content icon-left\"><div class=\"gutena-tab-title-text\"><div>Logistica<\/div><\/div><\/div><\/li><\/ul><div class=\"gutena-tabs-content is-layout-flow wp-block-gutena-tabs-is-layout-flow\">\n<div class=\"wp-block-gutena-tab gutena-tab-block gutena-tab-block-52f16d-9e active\" data-tab=\"1\">\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Preparazione e manutenzione del TMF<\/strong><\/h3>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph translation-block\">We4 Clinical Research configura e mantiene il <strong>Trial Master File (TMF)<\/strong> durante l'intera durata dello studio. Il TMF funge da repository completo di <strong>documenti essenziali dello studio<\/strong> e record. Garantiamo che il TMF sia stabilito e mantenuto secondo i requisiti regolatori, facilitando un'efficace <strong>gestione documentale<\/strong> e preparazione per ispezioni.<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-small-font-size\">Preparazione e inoltro ISF<\/h3>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph translation-block\">We4 Clinical Research supporta la configurazione e l'inoltro del <strong>Investigator Study File (ISF)<\/strong> ai siti clinici. L'ISF contiene documenti e record essenziali specifici per ciascun investigator e sito coinvolto nello studio. Garantiamo che l'ISF sia adeguatamente preparato, organizzato e inoltrato ai siti, promuovendo compliance e <strong>integrit\u00e0 documentale<\/strong>.<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-small-font-size\">Preparazione e presentazione della documentazione per il Comitato Etico (CE) e l'Autorit\u00e0 Competente (CA)<\/h3>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph translation-block\">We4 Clinical Research offre supporto allo sponsor nella determinazione della <strong>dimensione campionaria appropriata<\/strong> per lo studio. Attraverso l'applicazione di metodologie statistiche e considerando fattori rilevanti come dimensione dell'effetto, potenza e livello di significativit\u00e0 desiderato, assistiamo nella definizione del <strong>numero ottimale di partecipanti<\/strong> necessario per ottenere risultati significativi e statisticamente robusti. La nostra expertise nel calcolo della dimensione campionaria garantisce che gli studi siano adeguatamente potenziati per trarre conclusioni accurate.<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-small-font-size\">Notifica all'autorit\u00e0 competente (per studi post-commercializzazione con dispositivi medici)<\/h3>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph translation-block\">We4 Clinical Research pu\u00f2 notificare l'Autorit\u00e0 Competente del Paese per <strong>sottomissione e approvazione degli studi post-commercializzazione<\/strong>.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-gutena-tab gutena-tab-block gutena-tab-block-f5b98e-70 inactive\" data-tab=\"2\">\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Negoziazione contrattuale<\/strong><\/h3>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph translation-block\">We4 Clinical Research assiste lo sponsor nella redazione e <strong>negoziazione del Clinical Trial Agreement (CTA)<\/strong> con i siti e altre istituzioni coinvolte. Garantiamo che il CTA rifletta i requisiti dello studio, protegga gli interessi di tutte le parti coinvolte e sia conforme alle considerazioni regolatorie e legali.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-gutena-tab gutena-tab-block gutena-tab-block-1b5724-0c inactive\" data-tab=\"3\">\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Riunioni degli Investigator<\/strong><\/h3>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph translation-block\">We4 Clinical Research assiste lo sponsor nella programmazione e organizzazione delle <strong>Riunioni degli Investigators<\/strong> nelle fasi iniziali e cruciali dello studio. Contribuiamo alla creazione di presentazioni e inviti ospiti, facilitando una comunicazione e collaborazione efficaci tra investigators e membri del team dello studio.<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Good Clinical Practice e altre certificazioni<\/strong><\/h3>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph translation-block\">We4 Clinical Research verifica le qualifiche degli investigators e supporta lo staff controllando le loro credenziali. Forniamo inoltre indicazioni sull'ottenimento e mantenimento efficiente della <strong>Certificazione GCP<\/strong>. Garantiamo che tutto il personale rilevante coinvolto nello studio soddisfi i requisiti di formazione e certificazione necessari.<\/p>\n\n\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Preparazione ed Esecuzione della Site Initiation Visit (SIV)<\/strong><\/h3>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph translation-block\">Il personale di We4 Clinical Research prepara materiali di training e conduce le <strong>Site Initiation Visit (SIV)<\/strong>. Queste visite rappresentano un'opportunit\u00e0 per formare il personale del sito sulle procedure dello studio, protocolli e requisiti regolatori. Garantiamo che i siti siano adeguatamente preparati per avviare lo studio e aderire alle linee guida necessarie.<\/p>\n<\/div>\n\n\n\n<div class=\"wp-block-gutena-tab gutena-tab-block gutena-tab-block-b065c5-69 inactive\" data-tab=\"4\">\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Gestione dei medicinali sperimentali (IMP) e dei dispositivi medici (MD)<\/strong><\/h3>\n\n\n\n<p class=\"has-small-font-size wp-block-paragraph translation-block\">We4 Clinical Research pu\u00f2 supportare lo sponsor nella <strong>gestione IMP\/MD<\/strong> durante tutto lo studio. Coordiniamo con i distributori per garantire che i siti di ricerca dispongano dei investigational products necessari per il trial. Possiamo monitorare aspetti come date di scadenza, utilizzo e recupero dei investigational products, assicurando la loro corretta gestione e <strong>conformit\u00e0 con i requisiti regolatori<\/strong>.<\/p>\n<\/div>\n<\/div><\/div>\n\n\n\n<div class=\"wp-block-group alignwide is-style-default has-tertiary-background-color has-background has-global-padding is-layout-constrained wp-container-core-group-is-layout-22f48162 wp-block-group-is-layout-constrained\" style=\"border-radius:5px;padding-top:var(--wp--preset--spacing--large);padding-right:var(--wp--preset--spacing--large);padding-bottom:var(--wp--preset--spacing--large);padding-left:var(--wp--preset--spacing--large)\">\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-0b1620ab wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-container-core-column-is-layout-e2a71e28 wp-block-column-is-layout-flow\" style=\"flex-basis:100%\">\n<p class=\"has-text-align-center has-medium-font-size wp-block-paragraph\" style=\"font-style:normal;font-weight:600\">Perch\u00e9 aspettare? Inizia il tuo trial<br> nel modo pi\u00f9 intelligente<\/p>\n\n\n\n<p class=\"has-text-align-center has-small-font-size wp-block-paragraph translation-block\">Una fase <strong>Start-Up <\/strong> ben eseguita \u00e8 la migliore garanzia per il successo di una sperimentazione clinica. Il nostro team \u00e8 pronto a supportarvi in ogni dettaglio, dalla strategia alla piena prontezza operativa.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\" style=\"margin-top:var(--wp--preset--spacing--medium)\">\n<div class=\"wp-block-button has-custom-width wp-block-button__width-100 lemonsqueezy-button is-style-button-brand is-style-button-brand--1\"><a class=\"wp-block-button__link has-text-align-center wp-element-button\" href=\"https:\/\/www.we4cr.com\/it\/quotation\/\">Iniziare ora<\/a><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>","protected":false},"excerpt":{"rendered":"<p>By Project Phase START UP The Start-up phase is where plans move into action. From securing approvals to getting sites ready to enroll, we coordinate every step so your trial launches on solid ground. Our tam handles submissions, site onboarding, contract negotiations and product logistics with precision and compliance at the forefront. Every document prepared, [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":75,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"page-no-title","meta":{"footnotes":""},"class_list":["post-129","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Start Up | We4 Clinical Research<\/title>\n<meta name=\"description\" content=\"By Project Phase START UP The Start-up phase is where plans move into action. 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