{"id":137,"date":"2025-08-07T16:53:32","date_gmt":"2025-08-07T14:53:32","guid":{"rendered":"https:\/\/testwp.marcocammarata.it\/?page_id=137"},"modified":"2026-09-28T16:24:12","modified_gmt":"2026-09-28T14:24:12","slug":"quality-services","status":"publish","type":"page","link":"https:\/\/www.we4cr.com\/it\/solutions\/quality-services\/","title":{"rendered":"Servizi di Qualit\u00e0"},"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)\"><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\">By Strategic Area<\/p>\n\n<h1 class=\"wp-block-heading has-text-align-center has-large-font-size\">Quality Services<\/h1>\n\n<p class=\"has-text-align-center has-base-font-size wp-block-paragraph\">For biotech and pharmaceutical companies, medical device manufacturers, non-profit organizations, and academic institutions that need to ensure the compliance and quality of their clinical studies, from study design through close-out and archiving.<\/p><\/div><div style=\"height:44px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div><div class=\"wp-block-group has-global-padding is-layout-constrained wp-block-group-is-layout-constrained\"><p class=\"has-text-align-center wp-block-paragraph\">Quality is not a final check, but a framework we build with you from the study design stage onward, to reduce the risk of non-compliance and protect the integrity of the data you will submit to regulatory authorities. Our Quality Management System for the conduct of clinical studies is ISO 9001:2015 certified (RINA, No. 45381\/24\/S).<\/p>\n\n<div class=\"wp-block-buttons is-content-justification-center is-layout-flex wp-container-core-buttons-is-layout-b7c91e0b wp-block-buttons-is-layout-flex\"><div class=\"wp-block-button is-style-button-brand is-style-button-brand--1\"><a class=\"wp-block-button__link has-text-align-center has-base-font-size has-custom-font-size wp-element-button\" href=\"#form\">Let&#8217;s talk<\/a><\/div><\/div><\/div><style id=\"we4cr-quality-css\">.w4y{--w4-navy:#0B2A4A;--w4-teal:#0A7F8A;--w4-tint:#EAF5F7;--w4-line:#D3E2E7;--w4-text:#3A4E62;--w4-mint:#9BDCE2;font-family:'Poppins',sans-serif;font-size:16px;line-height:1.65;color:var(--w4-text);max-width:100%;overflow-x:clip;-webkit-font-smoothing:antialiased}\r\n.w4y *,.w4y *::before,.w4y *::after{box-sizing:border-box}\r\n.w4y h2,.w4y h3,.w4y 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.w4y-cards{grid-template-columns:repeat(6,minmax(0,1fr));gap:24px;max-width:none;margin:0}\r\n.w4y .w4y-card{grid-column:span 2;padding:36px 32px;border-radius:28px}\r\n.w4y .w4y-card:nth-child(4),.w4y .w4y-card:nth-child(5){grid-column:span 3}\r\n.w4y .w4y-icon{width:60px;height:60px;border-radius:18px}\r\n.w4y .w4y-faq{grid-template-columns:minmax(0,4fr) minmax(0,7fr);gap:80px;max-width:none;margin:0;align-items:start}\r\n.w4y .w4y-qa__item{padding:0 32px}\r\n.w4y button.w4y-qa__trigger{padding:22px 0}\r\n.w4y .w4y-qa__inner p{padding-right:40px}\r\n}\r\n@media (prefers-reduced-motion:reduce){\r\n.w4y *,.w4y *::before,.w4y *::after{transition:none!important}\r\n}<\/style><div class=\"w4y\" id=\"w4y-1\"><section class=\"w4y-sec w4y-sec--light\" aria-label=\"Quality services\"><div class=\"w4y-wrap\"><div class=\"w4y-cards\"><article class=\"w4y-card\"><div class=\"w4y-icon\"><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.6\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\" focusable=\"false\"><rect x=\"6\" y=\"4\" width=\"12\" height=\"17\" rx=\"2\"\/><path d=\"M9 4h6v3H9z\"\/><path d=\"M9 13.5l2 2 4-4\"\/><\/svg><\/div><h2 class=\"w4y-card__title\">Quality plan and SOPs<\/h2><p class=\"w4y-card__text\">We draft the study quality plan and develop or adapt the sponsor\u2019s standard operating procedures (SOPs), aligned with ICH GCP and, for medical devices, with ISO 14155.<\/p><\/article><article class=\"w4y-card\"><div class=\"w4y-icon\"><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.6\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\" focusable=\"false\"><circle cx=\"11\" cy=\"11\" r=\"6\"\/><path d=\"M20 20l-4.2-4.2\"\/><path d=\"M8.5 11l1.8 1.8 3.2-3.4\"\/><\/svg><\/div><h2 class=\"w4y-card__title\">Audits and inspections<\/h2><p class=\"w4y-card__text\">We conduct audits of the study\u2019s sites, processes and vendors and prepare you for inspections by the authorities, with support during the inspection as well.<\/p><\/article><article class=\"w4y-card\"><div class=\"w4y-icon\"><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.6\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\" focusable=\"false\"><path d=\"M12 3.5l9.5 16.5h-19z\"\/><path d=\"M12 10v4.5M12 17.2v.1\"\/><\/svg><\/div><h2 class=\"w4y-card__title\">Non-conformities and CAPA<\/h2><p class=\"w4y-card__text\">We identify deviations from the protocol and SOPs and manage the corrective and preventive actions (CAPA) needed to close them, with full traceability.<\/p><\/article><article class=\"w4y-card\"><div class=\"w4y-icon\"><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.6\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\" focusable=\"false\"><path d=\"M4 16a8 8 0 1 1 16 0\"\/><path d=\"M12 16l4-5\"\/><circle cx=\"12\" cy=\"16\" r=\"1.2\"\/><path d=\"M4 20h16\"\/><\/svg><\/div><h2 class=\"w4y-card__title\">Risk management (RBQM)<\/h2><p class=\"w4y-card__text\">We identify the factors critical to quality for each study and build the risk management plan that guides monitoring and controls.<\/p><\/article><article class=\"w4y-card\"><div class=\"w4y-icon\"><svg viewBox=\"0 0 24 24\" fill=\"none\" stroke=\"currentColor\" stroke-width=\"1.6\" stroke-linecap=\"round\" stroke-linejoin=\"round\" aria-hidden=\"true\" focusable=\"false\"><path d=\"M3 6h11v10H3z\"\/><path d=\"M14 9h4l3 3v4h-7z\"\/><circle cx=\"7\" cy=\"18\" r=\"1.8\"\/><circle cx=\"17\" cy=\"18\" r=\"1.8\"\/><\/svg><\/div><h2 class=\"w4y-card__title\">Vendor qualification<\/h2><p class=\"w4y-card__text\">We qualify and oversee the study\u2019s vendors (laboratories, couriers, technology providers) so that they work in accordance with GCP.<\/p><\/article><\/div><\/div><\/section><\/div><div class=\"w4y\" id=\"w4y-2\"><section class=\"w4y-sec w4y-sec--tint\" aria-labelledby=\"w4y-2-faq\"><div class=\"w4y-wrap\"><div class=\"w4y-faq\"><h2 class=\"w4y-h2\" id=\"w4y-2-faq\">People also ask\u2026<\/h2><div class=\"w4y-qa\" data-open-first=\"1\"><div class=\"w4y-qa__item\" data-open=\"1\"><h3 class=\"w4y-qa__h\"><button type=\"button\" class=\"w4y-qa__trigger\" id=\"w4y-2-q-b0\" aria-expanded=\"true\" aria-controls=\"w4y-2-q-p0\"><span class=\"w4y-qa__label\">Can you prepare us for an inspection by the authorities?<\/span><span class=\"w4y-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4y-qa__panel\" id=\"w4y-2-q-p0\" role=\"region\" aria-labelledby=\"w4y-2-q-b0\"><div class=\"w4y-qa__inner\"><p>Yes: we assess the readiness of documents, Trial Master File and processes and support your team during the inspection as well.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/div><script 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