{"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":"2026-09-28T16:47:34","modified_gmt":"2026-09-28T14:47:34","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)\"><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 Project Phase<\/p>\n\n<h1 class=\"wp-block-heading has-text-align-center has-large-font-size\">Clinical Study Start-Up<\/h1>\n\n<p class=\"has-text-align-center has-small-font-size wp-block-paragraph\">For biotech and pharmaceutical companies, medical device manufacturers, non-profit organizations, and academic institutions that need to obtain approvals and activate study sites for clinical studies involving drugs or medical devices.<\/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\">During study start-up, initial plans turn into action. From regulatory approvals to site preparation, we coordinate every step so patient enrollment can begin on time, accurately, and in full compliance with applicable requirements.<\/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><div style=\"height:83px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div><div class=\"wp-block-cover alignfull is-light\" style=\"margin-top:0;margin-bottom:0;padding-top:0;padding-right:0;padding-bottom:0;padding-left:0;min-height:50px;aspect-ratio:unset;\"><video class=\"wp-block-cover__video-background intrinsic-ignore\" autoplay muted loop playsinline src=\"https:\/\/www.we4cr.com\/wp-content\/uploads\/2025\/08\/3214527-uhd_3840_2160_25fps.mp4\" data-object-fit=\"cover\"><\/video><span aria-hidden=\"true\" class=\"wp-block-cover__background has-primary-background-color has-background-dim-90 has-background-dim\"><\/span><div class=\"wp-block-cover__inner-container is-layout-flow wp-block-cover-is-layout-flow\"><div class=\"wp-block-group alignfull has-base-color has-text-color has-global-padding is-layout-constrained wp-container-core-group-is-layout-00c6e1e0 wp-block-group-is-layout-constrained\" style=\"margin-top:0;margin-bottom:0;padding-top:var(--wp--preset--spacing--xx-large);padding-right:var(--wp--preset--spacing--medium);padding-bottom:var(--wp--preset--spacing--xx-large);padding-left:var(--wp--preset--spacing--medium)\"><div class=\"wp-block-columns alignwide is-layout-flex wp-container-core-columns-is-layout-d064aeaa wp-block-columns-is-layout-flex\"><div class=\"wp-block-column is-layout-flow wp-container-core-column-is-layout-e2a71e28 wp-block-column-is-layout-flow\"><h3 class=\"wp-block-heading has-text-align-center o-count-faster has-x-large-font-size\">55+<\/h3>\n\n<p class=\"has-text-align-center has-base-color has-text-color has-base-font-size wp-block-paragraph\" style=\"font-style:normal;font-weight:600\">Clinical studies<\/p><\/div>\n\n<div class=\"wp-block-column is-layout-flow wp-container-core-column-is-layout-e2a71e28 wp-block-column-is-layout-flow\"><h3 class=\"wp-block-heading has-text-align-center o-count-faster has-x-large-font-size\"><o-anim-count>600<\/o-anim-count>+<\/h3>\n\n<p class=\"has-text-align-center has-base-color has-text-color has-base-font-size wp-block-paragraph\" style=\"font-style:normal;font-weight:600\">Investigators<\/p><\/div>\n\n<div class=\"wp-block-column is-layout-flow wp-container-core-column-is-layout-e2a71e28 wp-block-column-is-layout-flow\"><h3 class=\"wp-block-heading has-text-align-center o-count-faster has-x-large-font-size\"><o-anim-count>300+<\/o-anim-count><\/h3>\n\n<p class=\"has-text-align-center has-base-color has-text-color has-base-font-size wp-block-paragraph\" style=\"font-style:normal;font-weight:600\">Hospitals<\/p><\/div>\n\n<div class=\"wp-block-column is-layout-flow wp-container-core-column-is-layout-e2a71e28 wp-block-column-is-layout-flow\"><h3 class=\"wp-block-heading has-text-align-center o-count-faster has-x-large-font-size\">16k+<\/h3>\n\n<p class=\"has-text-align-center has-base-color has-text-color has-base-font-size wp-block-paragraph\" style=\"font-style:normal;font-weight:600\">Patients<\/p><\/div><\/div><\/div><\/div><\/div><div class=\"wp-block-group has-global-padding is-layout-constrained wp-block-group-is-layout-constrained\"><div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n<h2 class=\"wp-block-heading has-text-align-center\"><mark style=\"background-color:rgba(0, 0, 0, 0);color:#43b2a4\" class=\"has-inline-color\">Before enrolling your first patient, are you concerned about&#8230;<\/mark><\/h2>\n\n<ul class=\"wp-block-list\"><li>Delays in study activation that push back the date of first patient enrollment.<\/li>\n\n<li>Submissions to ethics committees and regulatory authorities, with different documentation requirements across countries and the risk of errors slowing down the study.<\/li>\n\n<li>Sites not being ready on the study start date, for example because contracts are still pending, staff have not yet been trained, or the investigational product has not arrived.<\/li><\/ul><\/div><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)\"><div class=\"wp-block-gutena-tabs alignwide gutena-tabs-block gutena-tabs-block-6b4e64-ee\"><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>Documents<\/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>Contracts<\/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>Training<\/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>Logistics<\/div><\/div><\/div><\/li><\/ul><div class=\"gutena-tabs-content is-layout-flow wp-block-gutena-tabs-is-layout-flow\"><div class=\"wp-block-gutena-tab gutena-tab-block gutena-tab-block-6e98ed-ad active\" data-tab=\"1\"><h3 class=\"wp-block-heading has-small-font-size\"><strong>TMF preparation and maintenance<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We4 Clinical Research sets up and maintains the <strong>Trial Master File (TMF)<\/strong> throughout the entire study duration. The TMF serves as a comprehensive<strong> repository of essential study documents <\/strong>and records. We ensure that the TMF is established and maintained according to regulatory requirements, facilitating efficient <strong>document management<\/strong> and inspection readiness.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\">ISF preparation and forwarding<\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We4 Clinical Research supports the setup and forwarding of the <strong>Investigator Study File (ISF) <\/strong>to clinical sites. The ISF contains essential documents and records specific to each investigator and site involved in the study. We ensure that the ISF is properly prepared, organised, and forwarded to sites, promoting compliance and <strong>documentation integrity<\/strong>.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\">Preparation and submission of Documentation for Ethics Committee (EC) and Competent Authority (CA)<\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We4 Clinical Research offers support to the sponsor in determining the <strong>appropriate sample size<\/strong> for the study. Through the application of statistical methodologies and considering relevant factors such as effect size, power, and desired level of significance, we assist in determining the <strong>optimal number of participants <\/strong>needed to achieve meaningful and statistically significant results. Our expertise in sample size calculation ensures that studies are adequately powered to draw accurate conclusions.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\">Notification to Competent Authority (for post-market Studies with medical devices)<\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We4 Clinical Research can notify the Country\u2019s Competent Authority for<strong> submission and approval of the post-market studies.<\/strong><\/p><\/div>\n\n<div class=\"wp-block-gutena-tab gutena-tab-block gutena-tab-block-3cc0ad-44 inactive\" data-tab=\"2\"><h3 class=\"wp-block-heading has-small-font-size\"><strong>Contract Negotiation<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We4 Clinical Research assists the sponsor in drafting and <strong>negotiating the Clinical Trial Agreement (CTA) <\/strong>with sites and other involved institutions. We ensure that the CTA reflects the study requirements, protects the interests of all parties involved, and complies with regulatory and legal considerations.<\/p><\/div>\n\n<div class=\"wp-block-gutena-tab gutena-tab-block gutena-tab-block-3f2a07-40 inactive\" data-tab=\"3\"><h3 class=\"wp-block-heading has-small-font-size\"><strong>Investigators\u2019 Meetings<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We4 Clinical Research assists the sponsor in scheduling and organising <strong>Investigators&#8217; Meetings <\/strong>in the early and crucial stages of the study. We contribute to creating presentations and inviting guests, facilitating effective communication and collaboration among investigators and study team members.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Good Clinical Practice and other certifications<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We4 Clinical Research verifies the qualifications of investigators and supports staff by checking their credentials. We also provide guidance on obtaining and maintaining <strong>GCP Certification <\/strong>efficiently. We ensure that all relevant personnel involved in the study meet the necessary training and certification requirements.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Site Initiation Visit (SIV) preparation and execution<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We4 Clinical Research&#8217;s staff prepares training materials and conducts <strong>Site Initiation Visits (SIV)<\/strong>. These visits serve as an opportunity to train site personnel on study procedures, protocols, and regulatory requirements. We ensure that sites are adequately prepared to initiate the study and adhere to the necessary guidelines.<\/p><\/div>\n\n<div class=\"wp-block-gutena-tab gutena-tab-block gutena-tab-block-fe9d17-62 inactive\" data-tab=\"4\"><h3 class=\"wp-block-heading has-small-font-size\"><strong>Investigational Medicinal Product (IMP) and Medical Devices (MD) Management<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We4 Clinical Research can support the sponsor to <strong>manage IMP\/MD <\/strong>throughout the study. We coordinate with distributors to ensure that research sites have the necessary investigational products for the trial. We can monitor aspects such as expiration dates, usage, and retrieval of investigational products, ensuring their proper management and <strong>compliance with regulatory requirements<\/strong>.<\/p><\/div><\/div><\/div>\n\n<style id=\"we4cr-startup-css\">.w4s{--w4-navy:#0B2A4A;--w4-teal:#0A7F8A;--w4-tint:#EAF5F7;--w4-line:#C9DCE2;--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.w4s *,.w4s *::before,.w4s *::after{box-sizing:border-box}\r\n.w4s h2,.w4s h3,.w4s h4,.w4s p{font-family:inherit;text-transform:none;letter-spacing:normal;margin:0;padding:0;background:none;border:0}\r\n.w4s svg{display:block;max-width:100%}\r\n.w4s .w4s-sec{padding:56px 0;background:#fff}\r\n.w4s .w4s-wrap{width:100%;max-width:1200px;margin:0 auto;padding:0 20px}\r\n.w4s .w4s-h2{margin-bottom:28px;font-size:clamp(1.75rem,1.25rem + 2.2vw,2.875rem);line-height:1.15;font-weight:700;color:var(--w4-navy)}\r\n.w4s .w4s-boxes{display:grid;grid-template-columns:minmax(0,1fr);gap:16px}\r\n.w4s .w4s-col{display:contents}\r\n.w4s .w4s-card--docs{order:1}\r\n.w4s .w4s-card--contracts{order:2}\r\n.w4s .w4s-card--training{order:3}\r\n.w4s .w4s-card--logistics{order:4}\r\n.w4s .w4s-card{min-width:0;padding:24px;border-radius:20px;background:var(--w4-tint);color:var(--w4-text)}\r\n.w4s .w4s-card--dark{background:var(--w4-navy);color:rgba(255,255,255,.86)}\r\n.w4s .w4s-head{display:flex;align-items:center;gap:14px;margin-bottom:20px}\r\n.w4s .w4s-icon{display:grid;flex:0 0 48px;place-items:center;width:48px;height:48px;border-radius:14px;background:var(--w4-teal);color:#fff}\r\n.w4s .w4s-icon svg{width:56%;height:56%}\r\n.w4s .w4s-title{font-size:clamp(1.35rem,1.2rem + .6vw,1.65rem);line-height:1.2;font-weight:700;color:var(--w4-navy)}\r\n.w4s .w4s-card--dark .w4s-title{color:#fff}\r\n.w4s .w4s-item+.w4s-item{margin-top:18px;padding-top:18px;border-top:1px solid var(--w4-line)}\r\n.w4s .w4s-card--dark .w4s-item+.w4s-item{border-top-color:rgba(255,255,255,.18)}\r\n.w4s .w4s-item__title{margin-bottom:6px;font-size:1.05rem;line-height:1.4;font-weight:600;color:var(--w4-navy)}\r\n.w4s .w4s-card--dark .w4s-item__title{color:#fff}\r\n.w4s .w4s-item__text{font-size:clamp(.95rem,.92rem + .2vw,1.0625rem);line-height:1.7;color:inherit}\r\n.w4s .w4s-cta-wrap{display:flex;justify-content:center;margin-top:32px}\r\n.w4s a.w4s-cta{display:inline-flex;align-items:center;justify-content:center;width:100%;min-height:52px;padding:14px 28px;border-radius:999px;background:var(--w4-teal);color:#fff;font-family:'Poppins',sans-serif;font-weight:600;font-size:1rem;line-height:1.2;text-decoration:none;box-shadow:none;transition:background-color .2s ease}\r\n.w4s a.w4s-cta:hover{background:var(--w4-navy);color:#fff}\r\n.w4s a.w4s-cta:focus-visible{outline:3px solid var(--w4-navy);outline-offset:3px;color:#fff}\r\n@media (min-width:700px){\r\n.w4s .w4s-sec{padding:80px 0}\r\n.w4s .w4s-wrap{padding:0 32px}\r\n.w4s .w4s-h2{margin-bottom:40px}\r\n.w4s .w4s-boxes{gap:20px;max-width:780px;margin:0 auto}\r\n.w4s .w4s-card{padding:32px;border-radius:24px}\r\n.w4s .w4s-head{gap:16px;margin-bottom:24px}\r\n.w4s .w4s-icon{flex-basis:56px;width:56px;height:56px;border-radius:16px}\r\n.w4s .w4s-item+.w4s-item{margin-top:22px;padding-top:22px}\r\n.w4s .w4s-cta-wrap{margin-top:44px}\r\n.w4s a.w4s-cta{width:auto;min-width:280px}\r\n}\r\n@media (min-width:1100px){\r\n.w4s .w4s-sec{padding:112px 0}\r\n.w4s .w4s-wrap{padding:0 48px}\r\n.w4s .w4s-h2{margin-bottom:56px}\r\n.w4s .w4s-boxes{grid-template-columns:repeat(2,minmax(0,1fr));gap:28px;align-items:start;max-width:none;margin:0}\r\n.w4s .w4s-col{display:flex;flex-direction:column;gap:28px}\r\n.w4s .w4s-card{padding:40px;border-radius:28px}\r\n.w4s .w4s-icon{flex-basis:60px;width:60px;height:60px;border-radius:18px}\r\n.w4s .w4s-item__title{font-size:1.1rem}\r\n.w4s .w4s-cta-wrap{margin-top:56px}\r\n.w4s a.w4s-cta{min-height:56px;padding:16px 44px}\r\n}<\/style><div class=\"w4s\" id=\"w4s-1\"><section class=\"w4s-sec\" aria-labelledby=\"w4s-1-title\"><div class=\"w4s-wrap\"><h2 class=\"w4s-h2\" id=\"w4s-1-title\">What Start-up activities include<\/h2><div class=\"w4s-boxes\"><div class=\"w4s-col\"><article class=\"w4s-card w4s-card--docs\" aria-labelledby=\"w4s-1-docs\"><div class=\"w4s-head\"><div class=\"w4s-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=\"M14 3H7a2 2 0 0 0-2 2v14a2 2 0 0 0 2 2h10a2 2 0 0 0 2-2V8z\"\/><path d=\"M14 3v5h5\"\/><path d=\"M9 13h6M9 17h4\"\/><\/svg><\/div><h3 class=\"w4s-title\" id=\"w4s-1-docs\">Documents<\/h3><\/div><div class=\"w4s-item\"><h4 class=\"w4s-item__title\">TMF preparation and maintenance<\/h4><p class=\"w4s-item__text\">We set up and update the Trial Master File (TMF), the archive of the study\u2019s essential documents and records, throughout the study and in line with regulatory requirements, for orderly document management and inspection readiness.<\/p><\/div><div class=\"w4s-item\"><h4 class=\"w4s-item__title\">ISF preparation and distribution<\/h4><p class=\"w4s-item__text\">We take care of setting up and sending to the sites the Investigator Site File (ISF), the file holding the documents specific to each investigator and site, prepared and organized to support compliance and document integrity.<\/p><\/div><div class=\"w4s-item\"><h4 class=\"w4s-item__title\">Documentation for the Ethics Committee and Competent Authority<\/h4><p class=\"w4s-item__text\">We prepare and submit the documentation for the Ethics Committee (EC) and the Competent Authority (CA), to obtain the approvals needed to start the study.<\/p><\/div><div class=\"w4s-item\"><h4 class=\"w4s-item__title\">European portals and requests for clarification<\/h4><p class=\"w4s-item__text\">For drug trials we manage the application in the European CTIS portal and, for clinical investigations of medical devices, the registration in EUDAMED when required. We answer information requests from ethics committees and authorities until approval.<\/p><\/div><div class=\"w4s-item\"><h4 class=\"w4s-item__title\">Notification to the Competent Authority (post-market studies with medical devices)<\/h4><p class=\"w4s-item__text\">For studies on devices that already carry the CE mark, we prepare and send the notification to the country\u2019s Competent Authority, in the cases where the MDR requires it.<\/p><\/div><\/article><article class=\"w4s-card w4s-card--logistics w4s-card--dark\" aria-labelledby=\"w4s-1-logistics\"><div class=\"w4s-head\"><div class=\"w4s-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 3l8 4.2v9.6L12 21l-8-4.2V7.2z\"\/><path d=\"M4 7.2l8 4.3 8-4.3M12 11.5V21\"\/><\/svg><\/div><h3 class=\"w4s-title\" id=\"w4s-1-logistics\">Logistics<\/h3><\/div><div class=\"w4s-item\"><h4 class=\"w4s-item__title\">Management of investigational medicinal products (IMPs) and medical devices<\/h4><p class=\"w4s-item__text\">We manage investigational products throughout the study. We coordinate distributors so that sites have the products they need and, finally, we monitor expiry dates, use and retrieval, for correct management that complies with regulatory requirements.<\/p><\/div><\/article><\/div><div class=\"w4s-col\"><article class=\"w4s-card w4s-card--contracts w4s-card--dark\" aria-labelledby=\"w4s-1-contracts\"><div class=\"w4s-head\"><div class=\"w4s-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=\"M14 3H7a2 2 0 0 0-2 2v14a2 2 0 0 0 2 2h3\"\/><path d=\"M14 3l5 5v2\"\/><path d=\"M14 3v5h5\"\/><path d=\"M12.5 20.5l.8-3 6.2-6.2a1.4 1.4 0 0 1 2 2l-6.2 6.2-2.8 1z\"\/><\/svg><\/div><h3 class=\"w4s-title\" id=\"w4s-1-contracts\">Contracts<\/h3><\/div><div class=\"w4s-item\"><h4 class=\"w4s-item__title\">Contract negotiation<\/h4><p class=\"w4s-item__text\">We handle the drafting and negotiation of the Clinical Trial Agreement (CTA), the contract between sponsor and site, with the sites and the other institutions involved, so that it reflects the requirements of the study, protects the interests of all parties and complies with regulatory and legal aspects.<\/p><\/div><\/article><article class=\"w4s-card w4s-card--training\" aria-labelledby=\"w4s-1-training\"><div class=\"w4s-head\"><div class=\"w4s-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=\"M2 9l10-5 10 5-10 5z\"\/><path d=\"M6 11.2V16c0 1.4 2.7 3 6 3s6-1.6 6-3v-4.8\"\/><path d=\"M22 9v6\"\/><\/svg><\/div><h3 class=\"w4s-title\" id=\"w4s-1-training\">Training<\/h3><\/div><div class=\"w4s-item\"><h4 class=\"w4s-item__title\">Investigator meetings<\/h4><p class=\"w4s-item__text\">We schedule and organize meetings with investigators in the early and critical phases of the study, with presentations and invitations, for effective communication and collaboration with the study team.<\/p><\/div><div class=\"w4s-item\"><h4 class=\"w4s-item__title\">GCP training and staff qualifications<\/h4><p class=\"w4s-item__text\">We check the qualifications and CVs of investigators and staff and verify that Good Clinical Practice (GCP) training is complete and up to date, so that all personnel involved are compliant before the start.<\/p><\/div><div class=\"w4s-item\"><h4 class=\"w4s-item__title\">Site Initiation Visit (SIV) preparation and delivery<\/h4><p class=\"w4s-item__text\">We prepare the training materials and conduct the Site Initiation Visits (SIVs), the start-up visits where site staff are trained on study procedures, the protocol and regulatory requirements.<\/p><\/div><div class=\"w4s-item\"><h4 class=\"w4s-item__title\">Site qualification<\/h4><p class=\"w4s-item__text\">Before activation, we verify that the staff, facilities and equipment of each site are suitable for the study, with selection visits carried out remotely or, when needed, on site.<\/p><\/div><\/article><\/div><\/div><div class=\"w4s-cta-wrap\"><a class=\"w4s-cta\" href=\"#form\">Tell us about your project<\/a><\/div><\/div><\/section><\/div>\n\n<style id=\"we4cr-metodo-css\">.w4cr-method{--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.w4cr-method *,.w4cr-method *::before,.w4cr-method *::after{box-sizing:border-box}\r\n.w4cr-method h2,.w4cr-method h3,.w4cr-method h4,.w4cr-method p{font-family:inherit;text-transform:none;letter-spacing:normal;margin:0;padding:0;background:none;border:0}\r\n.w4cr-method svg{display:block;max-width:100%}\r\n.w4cr-method .w4cr-sec{position:relative;overflow:hidden;padding:56px 0}\r\n.w4cr-method 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.5vw,1.35rem);line-height:1.4;font-weight:500;color:var(--w4-mint)}\r\n.w4cr-method .w4cr-cards{display:grid;grid-template-columns:minmax(0,1fr);gap:16px}\r\n.w4cr-method .w4cr-card{display:grid;grid-template-columns:minmax(0,1fr);gap:16px;padding:24px;border-radius:20px;background:rgba(255,255,255,.06);border:1px solid rgba(255,255,255,.18)}\r\n.w4cr-method .w4cr-icon{display:grid;place-items:center;width:52px;height:52px;border-radius:16px;background:var(--w4-teal);color:#fff}\r\n.w4cr-method .w4cr-icon svg{width:56%;height:56%}\r\n.w4cr-method .w4cr-card__title{font-size:1.25rem;line-height:1.3;font-weight:600;color:#fff}\r\n.w4cr-method .w4cr-card__text{margin-top:6px;font-size:.98rem;line-height:1.65;color:rgba(255,255,255,.86)}\r\n.w4cr-method .w4cr-split{display:grid;grid-template-columns:minmax(0,1fr);grid-template-areas:\"head\" \"media\" \"acc\";gap:28px;align-items:start}\r\n.w4cr-method .w4cr-split__head{grid-area:head}\r\n.w4cr-method 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(min-width:700px){\r\n.w4cr-method .w4cr-sec{padding:80px 0}\r\n.w4cr-method .w4cr-wrap{padding:0 32px}\r\n.w4cr-method .w4cr-deco--ring{width:420px;height:420px;top:-150px;right:-160px}\r\n.w4cr-method .w4cr-deco--dots{display:block}\r\n.w4cr-method .w4cr-head{margin-bottom:44px}\r\n.w4cr-method .w4cr-cards{gap:20px;max-width:780px;margin:0 auto 0 0}\r\n.w4cr-method .w4cr-card{grid-template-columns:72px minmax(0,1fr);gap:24px;padding:28px;border-radius:24px;align-items:start}\r\n.w4cr-method .w4cr-icon{width:72px;height:72px;border-radius:20px}\r\n.w4cr-method .w4cr-card__title{font-size:1.35rem}\r\n.w4cr-method .w4cr-split{max-width:780px;margin:0 auto;gap:36px}\r\n.w4cr-method .w4cr-media{--off:14px;aspect-ratio:16\/9}\r\n.w4cr-method .w4cr-media::before,.w4cr-method .w4cr-media__box{border-radius:24px}\r\n.w4cr-method button.w4cr-acc__trigger{padding:20px 0}\r\n.w4cr-method .w4cr-cta-wrap{margin-top:48px}\r\n.w4cr-method a.w4cr-cta{width:auto;min-width:280px}\r\n}\r\n@media (min-width:1100px){\r\n.w4cr-method .w4cr-sec{padding:112px 0}\r\n.w4cr-method .w4cr-wrap{padding:0 48px}\r\n.w4cr-method .w4cr-deco--ring{width:560px;height:560px;top:-190px;right:-170px}\r\n.w4cr-method .w4cr-deco--dots{width:260px;height:64px;right:48px;bottom:28px}\r\n.w4cr-method .w4cr-head{margin-bottom:64px}\r\n.w4cr-method .w4cr-cards{grid-template-columns:repeat(3,minmax(0,1fr));gap:28px;max-width:none}\r\n.w4cr-method .w4cr-card{grid-template-columns:minmax(0,1fr);gap:28px;padding:40px 36px;border-radius:28px}\r\n.w4cr-method .w4cr-icon{width:68px;height:68px}\r\n.w4cr-method .w4cr-card__title{font-size:1.45rem}\r\n.w4cr-method .w4cr-card__text{font-size:1.02rem}\r\n.w4cr-method .w4cr-split{max-width:none;margin:0;grid-template-columns:minmax(0,5fr) minmax(0,6fr);grid-template-areas:\"media head\" \"media acc\";column-gap:80px;row-gap:32px;align-content:center}\r\n.w4cr-method .w4cr-split--rev{grid-template-columns:minmax(0,6fr) minmax(0,5fr);grid-template-areas:\"head media\" \"acc media\"}\r\n.w4cr-method .w4cr-split__head{align-self:end}\r\n.w4cr-method .w4cr-split__acc{align-self:start}\r\n.w4cr-method .w4cr-media{--off:20px;aspect-ratio:4\/5;align-self:center}\r\n.w4cr-method .w4cr-media::before,.w4cr-method .w4cr-media__box{border-radius:28px}\r\n.w4cr-method button.w4cr-acc__trigger{padding:22px 0}\r\n.w4cr-method .w4cr-acc__inner p{padding-right:48px}\r\n.w4cr-method .w4cr-cta-wrap{margin-top:56px}\r\n.w4cr-method a.w4cr-cta{min-height:56px;padding:16px 44px}\r\n}\r\n@media (prefers-reduced-motion:reduce){\r\n.w4cr-method *,.w4cr-method *::before,.w4cr-method *::after{transition:none!important}\r\n}<\/style><div class=\"w4cr-method\" id=\"w4cr-1\"><section class=\"w4cr-sec w4cr-sec--dark\" aria-labelledby=\"w4cr-1-method\"><svg class=\"w4cr-deco w4cr-deco--ring\" viewBox=\"0 0 560 560\" fill=\"none\" aria-hidden=\"true\" focusable=\"false\"><g stroke=\"#9BDCE2\"><circle cx=\"280\" cy=\"280\" r=\"270\" stroke-opacity=\".14\"\/><circle cx=\"280\" cy=\"280\" r=\"210\" stroke-opacity=\".12\"\/><circle cx=\"280\" cy=\"280\" r=\"150\" stroke-opacity=\".1\"\/><circle cx=\"280\" cy=\"280\" r=\"90\" stroke-opacity=\".08\"\/><\/g><\/svg><div class=\"w4cr-deco w4cr-deco--dots\" aria-hidden=\"true\"><\/div><div class=\"w4cr-wrap\"><div class=\"w4cr-head\"><h2 class=\"w4cr-h2\" id=\"w4cr-1-method\">The We4CR Method<\/h2><h3 class=\"w4cr-lead\">What guides us<\/h3><\/div><div class=\"w4cr-cards\"><div class=\"w4cr-card\"><div class=\"w4cr-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 3l7 3v5c0 4.6-3 8.4-7 10-4-1.6-7-5.4-7-10V6l7-3z\"\/><path d=\"M9 12l2 2 4-4\"\/><\/svg><\/div><div><h4 class=\"w4cr-card__title\">Risk-based<\/h4><p class=\"w4cr-card__text\">Controls and resources always proportionate to the risk of each study.<\/p><\/div><\/div><div class=\"w4cr-card\"><div class=\"w4cr-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 20.5s-7.5-4.6-7.5-10.4A4.1 4.1 0 0 1 12 7.6a4.1 4.1 0 0 1 7.5 2.5c0 5.8-7.5 10.4-7.5 10.4z\"\/><path d=\"M12 10.5v4M10 12.5h4\"\/><\/svg><\/div><div><h4 class=\"w4cr-card__title\">Patient Centric<\/h4><p class=\"w4cr-card__text\">Studies designed around patients\u2019 needs.<\/p><\/div><\/div><div class=\"w4cr-card\"><div class=\"w4cr-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=\"12\" cy=\"9\" r=\"5.5\"\/><path d=\"M9.6 9l1.7 1.7 3.3-3.3\"\/><path d=\"M8.6 13.6L7 21l5-2.8 5 2.8-1.6-7.4\"\/><\/svg><\/div><div><h4 class=\"w4cr-card__title\">Quality over quantity<\/h4><p class=\"w4cr-card__text\">The rigor of our work comes before the numbers.<\/p><\/div><\/div><\/div><\/div><\/section><section class=\"w4cr-sec w4cr-sec--light\" aria-labelledby=\"w4cr-1-study\"><div class=\"w4cr-wrap\"><div class=\"w4cr-split\"><div class=\"w4cr-split__head\"><h2 class=\"w4cr-h2\" id=\"w4cr-1-study\">What you get in every study with We4CR<\/h2><\/div><div class=\"w4cr-media\"><div class=\"w4cr-media__box\"><svg viewBox=\"0 0 400 500\" preserveAspectRatio=\"xMidYMid slice\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" aria-hidden=\"true\" focusable=\"false\"><defs><linearGradient id=\"w4cr-1-s1-g\" x1=\"0\" y1=\"0\" x2=\"1\" y2=\"1\"><stop offset=\"0\" stop-color=\"#0B2A4A\"\/><stop offset=\"1\" stop-color=\"#0A7F8A\"\/><\/linearGradient><\/defs><rect width=\"400\" height=\"500\" fill=\"url(#w4cr-1-s1-g)\"\/><g stroke=\"#fff\" stroke-opacity=\".3\" stroke-width=\"1.5\" fill=\"none\"><path d=\"M200 250L90 120M200 250L310 110M200 250L340 270M200 250L280 410M200 250L100 390M200 250L60 260\"\/><path d=\"M90 120L310 110L340 270L280 410L100 390L60 260Z\" stroke-opacity=\".16\"\/><\/g><circle cx=\"200\" cy=\"250\" r=\"64\" fill=\"none\" stroke=\"#fff\" stroke-opacity=\".22\" stroke-width=\"1.5\"\/><circle cx=\"200\" cy=\"250\" r=\"38\" fill=\"#fff\" fill-opacity=\".14\"\/><circle cx=\"200\" cy=\"250\" r=\"16\" fill=\"#fff\"\/><g fill=\"#fff\"><circle cx=\"90\" cy=\"120\" r=\"10\" fill-opacity=\".9\"\/><circle cx=\"310\" cy=\"110\" r=\"14\" fill-opacity=\".75\"\/><circle cx=\"340\" cy=\"270\" r=\"9\" fill-opacity=\".9\"\/><circle cx=\"280\" cy=\"410\" r=\"13\" fill-opacity=\".75\"\/><circle cx=\"100\" cy=\"390\" r=\"10\" fill-opacity=\".9\"\/><circle cx=\"60\" cy=\"260\" r=\"8\" fill-opacity=\".7\"\/><\/g><\/svg><\/div><\/div><div class=\"w4cr-split__acc\"><div class=\"w4cr-acc\" data-open-first=\"1\"><div class=\"w4cr-acc__item\" data-open=\"1\"><h4 class=\"w4cr-acc__h\"><button type=\"button\" class=\"w4cr-acc__trigger\" id=\"w4cr-1-a1-b0\" aria-expanded=\"true\" aria-controls=\"w4cr-1-a1-p0\"><span class=\"w4cr-acc__label\">Integrated technology<\/span><span class=\"w4cr-acc__ico\" aria-hidden=\"true\"><\/span><\/button><\/h4><div class=\"w4cr-acc__panel\" id=\"w4cr-1-a1-p0\" role=\"region\" aria-labelledby=\"w4cr-1-a1-b0\"><div class=\"w4cr-acc__inner\"><p>Tools developed by the We4 group support decentralized trials and operational flexibility, driving speed and quality without compromising compliance.<\/p><\/div><\/div><\/div><div class=\"w4cr-acc__item\" data-open=\"1\"><h4 class=\"w4cr-acc__h\"><button type=\"button\" class=\"w4cr-acc__trigger\" id=\"w4cr-1-a1-b1\" aria-expanded=\"true\" aria-controls=\"w4cr-1-a1-p1\"><span class=\"w4cr-acc__label\">More predictable timelines<\/span><span class=\"w4cr-acc__ico\" aria-hidden=\"true\"><\/span><\/button><\/h4><div class=\"w4cr-acc__panel\" id=\"w4cr-1-a1-p1\" role=\"region\" aria-labelledby=\"w4cr-1-a1-b1\"><div class=\"w4cr-acc__inner\"><p>Site selection strategies and patient engagement tools help reduce recruitment delays and dropouts, containing cost overruns and making time-to-market more predictable.<\/p><\/div><\/div><\/div><div class=\"w4cr-acc__item\" data-open=\"1\"><h4 class=\"w4cr-acc__h\"><button type=\"button\" class=\"w4cr-acc__trigger\" id=\"w4cr-1-a1-b2\" aria-expanded=\"true\" aria-controls=\"w4cr-1-a1-p2\"><span class=\"w4cr-acc__label\">Patient engagement<\/span><span class=\"w4cr-acc__ico\" aria-hidden=\"true\"><\/span><\/button><\/h4><div class=\"w4cr-acc__panel\" id=\"w4cr-1-a1-p2\" role=\"region\" aria-labelledby=\"w4cr-1-a1-b2\"><div class=\"w4cr-acc__inner\"><p>Our digital solutions turn patients into active participants in the study, supporting retention and protecting the sponsor\u2019s investment.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"w4cr-sec w4cr-sec--tint\" aria-labelledby=\"w4cr-1-services\"><div class=\"w4cr-wrap\"><div class=\"w4cr-split w4cr-split--rev\"><div class=\"w4cr-split__head\"><h2 class=\"w4cr-h2\" id=\"w4cr-1-services\">Services tailored to your study<\/h2><\/div><div class=\"w4cr-media\"><div class=\"w4cr-media__box\"><svg viewBox=\"0 0 400 500\" preserveAspectRatio=\"xMidYMid slice\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" aria-hidden=\"true\" focusable=\"false\"><defs><linearGradient id=\"w4cr-1-s2-g\" x1=\"0\" y1=\"0\" x2=\"1\" y2=\"1\"><stop offset=\"0\" stop-color=\"#0B2A4A\"\/><stop offset=\"1\" stop-color=\"#0A7F8A\"\/><\/linearGradient><\/defs><rect width=\"400\" height=\"500\" fill=\"url(#w4cr-1-s2-g)\"\/><g><rect x=\"48\" y=\"70\" width=\"170\" height=\"96\" rx=\"18\" fill=\"#fff\" fill-opacity=\".92\"\/><rect x=\"232\" y=\"70\" width=\"120\" height=\"96\" rx=\"18\" fill=\"#fff\" fill-opacity=\".18\"\/><rect x=\"48\" y=\"182\" width=\"96\" height=\"120\" rx=\"18\" fill=\"#fff\" fill-opacity=\".18\"\/><rect x=\"158\" y=\"182\" width=\"194\" height=\"120\" rx=\"18\" fill=\"#fff\" fill-opacity=\".55\"\/><rect x=\"48\" y=\"318\" width=\"150\" height=\"112\" rx=\"18\" fill=\"#fff\" fill-opacity=\".3\"\/><rect x=\"212\" y=\"318\" width=\"140\" height=\"112\" rx=\"18\" fill=\"#fff\" fill-opacity=\".92\"\/><\/g><g fill=\"#0A7F8A\"><circle cx=\"82\" cy=\"104\" r=\"8\"\/><circle cx=\"246\" cy=\"350\" r=\"8\"\/><\/g><\/svg><\/div><\/div><div class=\"w4cr-split__acc\"><div class=\"w4cr-acc\" data-open-first=\"1\"><div class=\"w4cr-acc__item\" data-open=\"1\"><h4 class=\"w4cr-acc__h\"><button type=\"button\" class=\"w4cr-acc__trigger\" id=\"w4cr-1-a2-b0\" aria-expanded=\"true\" aria-controls=\"w4cr-1-a2-p0\"><span class=\"w4cr-acc__label\">Modularity<\/span><span class=\"w4cr-acc__ico\" aria-hidden=\"true\"><\/span><\/button><\/h4><div class=\"w4cr-acc__panel\" id=\"w4cr-1-a2-p0\" role=\"region\" aria-labelledby=\"w4cr-1-a2-b0\"><div class=\"w4cr-acc__inner\"><p>Our flexible, modular way of working adapts to each sponsor\u2019s operating model, so resources are used efficiently.<\/p><\/div><\/div><\/div><div class=\"w4cr-acc__item\" data-open=\"1\"><h4 class=\"w4cr-acc__h\"><button type=\"button\" class=\"w4cr-acc__trigger\" id=\"w4cr-1-a2-b1\" aria-expanded=\"true\" aria-controls=\"w4cr-1-a2-p1\"><span class=\"w4cr-acc__label\">Scalability<\/span><span class=\"w4cr-acc__ico\" aria-hidden=\"true\"><\/span><\/button><\/h4><div class=\"w4cr-acc__panel\" id=\"w4cr-1-a2-p1\" role=\"region\" aria-labelledby=\"w4cr-1-a2-b1\"><div class=\"w4cr-acc__inner\"><p>We build flexible, on-demand teams calibrated to the needs of each project, matching resources and expertise to the complexity of the study and its therapeutic area.<\/p><\/div><\/div><\/div><div class=\"w4cr-acc__item\" data-open=\"1\"><h4 class=\"w4cr-acc__h\"><button type=\"button\" class=\"w4cr-acc__trigger\" id=\"w4cr-1-a2-b2\" aria-expanded=\"true\" aria-controls=\"w4cr-1-a2-p2\"><span class=\"w4cr-acc__label\">Dedicated team<\/span><span class=\"w4cr-acc__ico\" aria-hidden=\"true\"><\/span><\/button><\/h4><div class=\"w4cr-acc__panel\" id=\"w4cr-1-a2-p2\" role=\"region\" aria-labelledby=\"w4cr-1-a2-b2\"><div class=\"w4cr-acc__inner\"><p>The same people follow your study from start to finish, with no internal handovers and a single point of contact who knows the whole history of the project.<\/p><\/div><\/div><\/div><div class=\"w4cr-acc__item\" data-open=\"1\"><h4 class=\"w4cr-acc__h\"><button type=\"button\" class=\"w4cr-acc__trigger\" id=\"w4cr-1-a2-b3\" aria-expanded=\"true\" aria-controls=\"w4cr-1-a2-p3\"><span class=\"w4cr-acc__label\">Partners around the world<\/span><span class=\"w4cr-acc__ico\" aria-hidden=\"true\"><\/span><\/button><\/h4><div class=\"w4cr-acc__panel\" id=\"w4cr-1-a2-p3\" role=\"region\" aria-labelledby=\"w4cr-1-a2-b3\"><div class=\"w4cr-acc__inner\"><p>We work with qualified local consultants when the project requires it.<\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/div><script>(function(){var root=document.getElementById('w4cr-1');if(!root){return;}\r\nroot.classList.add('w4cr-js');\r\nArray.prototype.forEach.call(root.querySelectorAll('.w4cr-acc'),function(acc){\r\nvar items=acc.querySelectorAll('.w4cr-acc__item');\r\nvar openFirst=acc.getAttribute('data-open-first')==='1';\r\nfunction setState(item,open){item.setAttribute('data-open',open?'1':'0');item.querySelector('.w4cr-acc__trigger').setAttribute('aria-expanded',open?'true':'false');}\r\nArray.prototype.forEach.call(items,function(item,i){\r\nsetState(item,openFirst&&i===0);\r\nitem.querySelector('.w4cr-acc__trigger').addEventListener('click',function(){\r\nvar willOpen=item.getAttribute('data-open')!=='1';\r\nArray.prototype.forEach.call(items,function(o){setState(o,false);});\r\nsetState(item,willOpen);\r\n});\r\n});\r\n});\r\n})();<\/script>\n\n<style id=\"we4cr-studi-css\">.w4i{--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.w4i *,.w4i *::before,.w4i *::after{box-sizing:border-box}\r\n.w4i h2,.w4i h3,.w4i p,.w4i ul,.w4i li{font-family:inherit;text-transform:none;letter-spacing:normal;margin:0;padding:0;background:none;border:0}\r\n.w4i ul,.w4i li{list-style:none}\r\n.w4i li::marker{content:\"\"}\r\n.w4i svg{display:block;max-width:100%}\r\n.w4i .w4i-sec{position:relative;padding:56px 0}\r\n.w4i .w4i-sec--light{background:#fff}\r\n.w4i .w4i-wrap{width:100%;max-width:1200px;margin:0 auto;padding:0 20px}\r\n.w4i .w4i-h2{font-size:clamp(1.75rem,1.25rem + 2.2vw,2.875rem);line-height:1.15;font-weight:700;color:var(--w4-navy)}\r\n.w4i 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rgba(255,255,255,.22);font-size:.92rem;line-height:1.3;color:#fff}\r\n.w4i .w4i-chip::before{content:\"\";flex:0 0 6px;width:6px;height:6px;border-radius:50%;background:var(--w4-mint)}\r\n.w4i .w4i-cta-wrap{display:flex;justify-content:center;margin-top:32px}\r\n.w4i a.w4i-cta{display:inline-flex;align-items:center;justify-content:center;width:100%;min-height:52px;padding:14px 28px;border-radius:999px;background:var(--w4-teal);color:#fff;font-family:'Poppins',sans-serif;font-weight:600;font-size:1rem;line-height:1.2;text-decoration:none;box-shadow:none;transition:background-color .2s ease}\r\n.w4i a.w4i-cta:hover{background:var(--w4-navy);color:#fff}\r\n.w4i a.w4i-cta:focus-visible{outline:3px solid var(--w4-navy);outline-offset:3px;color:#fff}\r\n@media (min-width:700px){\r\n.w4i .w4i-sec{padding:80px 0}\r\n.w4i .w4i-wrap{padding:0 32px}\r\n.w4i .w4i-panels{gap:24px}\r\n.w4i .w4i-cta-wrap{margin-top:44px}\r\n.w4i a.w4i-cta{width:auto;min-width:280px}\r\n}\r\n@media (min-width:1100px){\r\n.w4i .w4i-sec{padding:112px 0}\r\n.w4i .w4i-wrap{padding:0 48px}\r\n.w4i .w4i-panels{gap:28px}\r\n.w4i .w4i-cta-wrap{margin-top:56px}\r\n.w4i a.w4i-cta{min-height:56px;padding:16px 44px}\r\n}\r\n@container (min-width:560px){\r\n.w4i .w4i-panel{padding:36px;border-radius:24px}\r\n.w4i .w4i-panel .w4i-h2{margin-bottom:26px}\r\n.w4i .w4i-deco{top:-90px;right:-90px;width:280px;height:280px}\r\n.w4i .w4i-tiles{grid-template-columns:repeat(2,minmax(0,1fr));gap:16px}\r\n.w4i .w4i-tile{grid-template-columns:minmax(0,1fr);gap:18px;align-items:start;padding:24px;border-radius:18px}\r\n.w4i .w4i-icon{width:56px;height:56px;border-radius:16px}\r\n.w4i .w4i-groups{gap:28px}\r\n.w4i .w4i-chips{gap:10px}\r\n.w4i .w4i-chip{padding:9px 16px;font-size:.95rem}\r\n}\r\n@container (min-width:900px){\r\n.w4i .w4i-panel{padding:48px;border-radius:28px}\r\n.w4i .w4i-panel .w4i-h2{margin-bottom:32px}\r\n.w4i .w4i-deco{top:-110px;right:-110px;width:360px;height:360px}\r\n.w4i .w4i-tile{grid-template-columns:64px minmax(0,1fr);gap:24px;align-items:center;padding:24px 28px}\r\n.w4i .w4i-icon{width:64px;height:64px;border-radius:18px}\r\n.w4i .w4i-groups{grid-template-columns:repeat(2,minmax(0,1fr));gap:40px;align-items:start}\r\n.w4i .w4i-ghead .w4i-icon{width:44px;height:44px}\r\n.w4i .w4i-chip{padding:10px 18px;font-size:1rem}\r\n}\r\n@media (prefers-reduced-motion:reduce){\r\n.w4i *,.w4i *::before,.w4i *::after{transition:none!important}\r\n}<\/style><div class=\"w4i\" id=\"w4i-1\"><section class=\"w4i-sec w4i-sec--light\" aria-label=\"Studies conducted and international presence\"><div class=\"w4i-wrap\"><div class=\"w4i-panels\"><div class=\"w4i-panel\"><h2 class=\"w4i-h2\">Studies conducted<\/h2><div class=\"w4i-tiles\"><div class=\"w4i-tile\"><div class=\"w4i-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=\"3\" y=\"5\" width=\"18\" height=\"12\" rx=\"2.5\"\/><path d=\"M6 11h3l1.5-3 3 6 1.5-3H18\"\/><path d=\"M9 20h6M12 17v3\"\/><\/svg><\/div><div><div class=\"w4i-num\">30+<\/div><p class=\"w4i-lbl\">studies on medical devices<\/p><\/div><\/div><div class=\"w4i-tile\"><div class=\"w4i-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=\"2.5\" y=\"8\" width=\"19\" height=\"8\" rx=\"4\" transform=\"rotate(-45 12 12)\"\/><path d=\"M9 9l6 6\"\/><\/svg><\/div><div><div class=\"w4i-num\">25+<\/div><p class=\"w4i-lbl\">studies on drugs<\/p><\/div><\/div><\/div><\/div><div class=\"w4i-panel\"><svg class=\"w4i-deco\" viewBox=\"0 0 200 200\" fill=\"none\" stroke=\"#9BDCE2\" stroke-opacity=\".16\" aria-hidden=\"true\" focusable=\"false\"><circle cx=\"100\" cy=\"100\" r=\"96\"\/><ellipse cx=\"100\" cy=\"100\" rx=\"52\" ry=\"96\"\/><ellipse cx=\"100\" cy=\"100\" rx=\"90\" ry=\"34\"\/><path d=\"M100 4v192M4 100h192\"\/><\/svg><h2 class=\"w4i-h2\">International presence<\/h2><div class=\"w4i-groups\"><div><div class=\"w4i-ghead\"><div class=\"w4i-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=\"12\" cy=\"12\" r=\"9\"\/><g fill=\"currentColor\" stroke=\"none\"><circle cx=\"12\" cy=\"7\" r=\"1\"\/><circle cx=\"15.5\" cy=\"8.5\" r=\"1\"\/><circle cx=\"17\" cy=\"12\" r=\"1\"\/><circle cx=\"15.5\" cy=\"15.5\" r=\"1\"\/><circle cx=\"12\" cy=\"17\" r=\"1\"\/><circle cx=\"8.5\" cy=\"15.5\" r=\"1\"\/><circle cx=\"7\" cy=\"12\" r=\"1\"\/><circle cx=\"8.5\" cy=\"8.5\" r=\"1\"\/><\/g><\/svg><\/div><div><h3 class=\"w4i-gtitle\">European Union<\/h3><p class=\"w4i-gcount\">7 countries<\/p><\/div><\/div><div class=\"w4i-chips\" role=\"list\"><span class=\"w4i-chip\" role=\"listitem\">Belgium<\/span><span class=\"w4i-chip\" role=\"listitem\">France<\/span><span class=\"w4i-chip\" role=\"listitem\">Ireland<\/span><span class=\"w4i-chip\" role=\"listitem\">Italy<\/span><span class=\"w4i-chip\" role=\"listitem\">Netherlands<\/span><span class=\"w4i-chip\" role=\"listitem\">Poland<\/span><span class=\"w4i-chip\" role=\"listitem\">Spain<\/span><\/div><\/div><div><div class=\"w4i-ghead\"><div class=\"w4i-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=\"12\" cy=\"12\" r=\"9\"\/><path d=\"M3 12h18\"\/><path d=\"M12 3c2.6 2.6 3.9 5.6 3.9 9s-1.3 6.4-3.9 9c-2.6-2.6-3.9-5.6-3.9-9S9.4 5.6 12 3z\"\/><\/svg><\/div><div><h3 class=\"w4i-gtitle\">Non-EU countries<\/h3><p class=\"w4i-gcount\">8 countries<\/p><\/div><\/div><div class=\"w4i-chips\" role=\"list\"><span class=\"w4i-chip\" role=\"listitem\">Bangladesh<\/span><span class=\"w4i-chip\" role=\"listitem\">Brazil<\/span><span class=\"w4i-chip\" role=\"listitem\">Brunei<\/span><span class=\"w4i-chip\" role=\"listitem\">Malaysia<\/span><span class=\"w4i-chip\" role=\"listitem\">United Kingdom<\/span><span class=\"w4i-chip\" role=\"listitem\">Singapore<\/span><span class=\"w4i-chip\" role=\"listitem\">Switzerland<\/span><span class=\"w4i-chip\" role=\"listitem\">Thailand<\/span><\/div><\/div><\/div><\/div><\/div><div class=\"w4i-cta-wrap\"><a class=\"w4i-cta\" href=\"#form\">Let\u2019s talk<\/a><\/div><\/div><\/section><\/div>\n\n<style id=\"we4cr-faq-startup-css\">.w4t{--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.w4t *,.w4t *::before,.w4t *::after{box-sizing:border-box}\r\n.w4t h2,.w4t h3,.w4t 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*::after{transition:none!important}\r\n}<\/style><div class=\"w4t\" id=\"w4t-1\"><section class=\"w4t-sec w4t-sec--tint\" aria-labelledby=\"w4t-1-faq\"><div class=\"w4t-wrap\"><div class=\"w4t-faq\"><h2 class=\"w4t-h2\" id=\"w4t-1-faq\">People also ask\u2026<\/h2><div class=\"w4t-qa\" data-open-first=\"1\"><div class=\"w4t-qa__item\" data-open=\"1\"><h3 class=\"w4t-qa__h\"><button type=\"button\" class=\"w4t-qa__trigger\" id=\"w4t-1-q-b0\" aria-expanded=\"true\" aria-controls=\"w4t-1-q-p0\"><span class=\"w4t-qa__label\">Who handles the requests to the Ethics Committee and the Competent Authority?<\/span><span class=\"w4t-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4t-qa__panel\" id=\"w4t-1-q-p0\" role=\"region\" aria-labelledby=\"w4t-1-q-b0\"><div class=\"w4t-qa__inner\"><p>We support you in preparing and submitting the documentation to the Ethics Committee (EC) and the Competent Authority (CA). For post-market studies with medical devices, we also notify the country\u2019s CA.<\/p><\/div><\/div><\/div><div class=\"w4t-qa__item\" data-open=\"1\"><h3 class=\"w4t-qa__h\"><button type=\"button\" class=\"w4t-qa__trigger\" id=\"w4t-1-q-b1\" aria-expanded=\"true\" aria-controls=\"w4t-1-q-p1\"><span class=\"w4t-qa__label\">How long does the Start-up phase of a study take?<\/span><span class=\"w4t-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4t-qa__panel\" id=\"w4t-1-q-p1\" role=\"region\" aria-labelledby=\"w4t-1-q-b1\"><div class=\"w4t-qa__inner\"><p>It depends on the countries involved, the number of sites, and the timelines of ethics committees and authorities. After an initial discovery call, we can outline timelines and steps for your case.<\/p><\/div><\/div><\/div><div class=\"w4t-qa__item\" data-open=\"1\"><h3 class=\"w4t-qa__h\"><button type=\"button\" class=\"w4t-qa__trigger\" id=\"w4t-1-q-b2\" aria-expanded=\"true\" aria-controls=\"w4t-1-q-p2\"><span class=\"w4t-qa__label\">Who negotiates the contract with the sites?<\/span><span class=\"w4t-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4t-qa__panel\" id=\"w4t-1-q-p2\" role=\"region\" aria-labelledby=\"w4t-1-q-b2\"><div class=\"w4t-qa__inner\"><p>We handle the drafting and negotiation of the Clinical Trial Agreement (CTA) with the sites and the other institutions involved, so that it reflects the requirements of the study and complies with regulatory and legal rules.<\/p><\/div><\/div><\/div><div class=\"w4t-qa__item\" data-open=\"1\"><h3 class=\"w4t-qa__h\"><button type=\"button\" class=\"w4t-qa__trigger\" id=\"w4t-1-q-b3\" aria-expanded=\"true\" aria-controls=\"w4t-1-q-p3\"><span class=\"w4t-qa__label\">How do you prepare sites before the start?<\/span><span class=\"w4t-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4t-qa__panel\" id=\"w4t-1-q-p3\" role=\"region\" aria-labelledby=\"w4t-1-q-b3\"><div class=\"w4t-qa__inner\"><p>We check the qualifications and credentials of investigators and staff, prepare the training materials and conduct the Site Initiation Visit (SIV), in which site staff are trained on study procedures, the protocol and regulatory requirements.<\/p><\/div><\/div><\/div><div class=\"w4t-qa__item\" data-open=\"1\"><h3 class=\"w4t-qa__h\"><button type=\"button\" class=\"w4t-qa__trigger\" id=\"w4t-1-q-b4\" aria-expanded=\"true\" aria-controls=\"w4t-1-q-p4\"><span class=\"w4t-qa__label\">Can I entrust you with the Start-up of the study only?<\/span><span class=\"w4t-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4t-qa__panel\" id=\"w4t-1-q-p4\" role=\"region\" aria-labelledby=\"w4t-1-q-b4\"><div class=\"w4t-qa__inner\"><p>Absolutely. Our services are flexible and modular: you can add other phases to your study if you need them, or entrust us with the study from protocol to close-out right from the start. <a class=\"w4t-link\" href=\"https:\/\/www.we4cr.com\/solutions\/\">Discover all our CRO solutions.<\/a><\/p><\/div><\/div><\/div><\/div><\/div><\/div><\/section><\/div><script type=\"application\/ld+json\">{\"@context\":\"https:\/\/schema.org\",\"@type\":\"FAQPage\",\"mainEntity\":[{\"@type\":\"Question\",\"name\":\"Who handles the requests to the Ethics Committee and the Competent Authority?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"We support you in preparing and submitting the documentation to the Ethics Committee (EC) and the Competent Authority (CA). 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From regulatory approvals to site preparation, we coordinate every step so [&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 v28.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Start Up | We4 Clinical Research<\/title>\n<meta name=\"description\" content=\"By Project Phase Clinical Study Start-Up For biotech and pharmaceutical companies, medical device manufacturers, non-profit organizations, and academic\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.we4cr.com\/it\/solutions\/start-up\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta 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