{"id":127,"date":"2025-08-07T16:52:57","date_gmt":"2025-08-07T14:52:57","guid":{"rendered":"https:\/\/testwp.marcocammarata.it\/?page_id=127"},"modified":"2026-09-29T12:22:00","modified_gmt":"2026-09-29T10:22:00","slug":"set-up","status":"publish","type":"page","link":"https:\/\/www.we4cr.com\/it\/solutions\/set-up\/","title":{"rendered":"Cosa comprendono le attivit\u00e0 di Set-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 Preparation<\/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 launching a clinical study 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 set-up, we align scientific objectives, regulatory requirements, and operational workflows before the study begins, so it is straightforward to conduct and compliant from the outset.<\/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 starting your study, are you concerned about&#8230;<\/mark><\/h2>\n\n<ul class=\"wp-block-list\"><li>Choosing the wrong sites and risking that they fail to enroll a single patient in your study.<\/li>\n\n<li>A poorly defined protocol leading to incomplete data and ongoing deviations.<\/li>\n\n<li>Different regulatory requirements across countries and not having the local expertise needed to manage them all.<\/li><\/ul>\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div><\/div><h2 class=\"wp-block-heading has-text-align-center\"><mark style=\"background-color:rgba(0, 0, 0, 0);color:#43b2a4\" class=\"has-inline-color\">What Set-up Activities Include<\/mark><\/h2><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-7e27cc-60\"><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>Strategy<\/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>Operations<\/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>Data<\/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>Quality<\/div><\/div><\/div><\/li><li class=\"gutena-tab-title inactive\" data-tab=\"5\"><div class=\"gutena-tab-title-content icon-left\"><div class=\"gutena-tab-title-text\"><div><strong>Visibility<\/strong><\/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-b21ef2-d4 active\" data-tab=\"1\"><h3 class=\"wp-block-heading has-small-font-size\"><strong>Protocol Review<\/strong> <\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We review every section of the protocol &#8211; the document defining the study objectives, methods and organisation &#8211; against Good Clinical Practice (GCP) guidelines, identifying inconsistencies and discrepancies before study start-up.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\">Preparation of Protocol Synopsis<\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We summarise the protocol in a clear, concise document outlining the primary objective and key study details, so stakeholders can quickly understand the study purpose and methodology.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Patient Information Sheet and Informed Consent Form<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We draft or adapt the Patient Information Sheet and Informed Consent Form in accordance with local regulations and the GDPR, ensuring that patients receive clear information and Ethics Committees are provided with compliant documentation.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Sample size calculation<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We determine the required number of participating patients based on effect size, statistical power and the desired significance level, so the study can generate reliable conclusions.<\/p>\n\n<p class=\"wp-block-paragraph\"><strong><strong>Statistical Analysis Plan (SAP)<\/strong><\/strong><\/p>\n\n<p class=\"wp-block-paragraph\">Before study start-up, we work with you to define the statistical tests and analyses for primary and secondary endpoints, ensuring that study conclusions are based on methods specified in advance.<\/p><\/div>\n\n<div class=\"wp-block-gutena-tab gutena-tab-block gutena-tab-block-241ae7-90 inactive\" data-tab=\"2\"><h3 class=\"wp-block-heading has-small-font-size\"><strong>Budgeting<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We estimate the resources required and calculate the per-patient fee, including recruitment, retention and compensation costs. This provides the basis for negotiating the Clinical Trial Agreement (CTA) with study sites during start-up.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\">Sites Feasibility and Sites Selection<\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We prepare and send feasibility questionnaires to potential sites and, based on their responses, select those that meet the study requirements and the characteristics you are looking for.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Local partners<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">In countries where a local presence is required, we select and qualify local partners by assessing their capabilities and experience against your study requirements, while remaining your single point of contact.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Laboratory and core lab selection<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We select laboratories for the analysis of biosamples, imaging and other study-related materials, conducting feasibility assessments of their capacity, equipment and expertise.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Insurance set-up<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We manage the process of arranging the appropriate insurance policy for your study, including liaison with brokers, quotation requests, preparation and distribution of documentation, and ongoing updates throughout the study.<\/p><\/div>\n\n<div class=\"wp-block-gutena-tab gutena-tab-block gutena-tab-block-9205df-aa inactive\" data-tab=\"3\"><h3 class=\"wp-block-heading has-small-font-size\"><strong>Data Management Plan Design<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">Together with you and the Principal Investigator, we develop a plan defining procedures and guidelines for data collection, storage, validation and analysis, helping safeguard the integrity and quality of the clinical study.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Case Report Form (CRF) Design<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We design a study-specific Case Report Form (CRF) that is comprehensive and easy to use.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>eCRF design<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We convert the CRF into an electronic Case Report Form (eCRF) within the EDC platform, incorporating automated edit checks that flag missing or inconsistent data at the point of entry.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Randomisation List generation<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">For randomised studies, we generate customised randomisation lists and define stratification factors and block sizes to support random and unbiased allocation to study arms.<\/p><\/div>\n\n<div class=\"wp-block-gutena-tab gutena-tab-block gutena-tab-block-797caf-55 inactive\" data-tab=\"4\"><h3 class=\"wp-block-heading has-small-font-size\"><strong>Data Safety Monitoring Board (DSMB) or Clinical Events Committee (CEC)<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We draft the committee charter\u2014the document defining its procedures\u2014and organise meetings on behalf of the sponsor, supporting appropriate oversight of participant safety and study integrity.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong><strong>Monitoring Plan<\/strong><\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We define the monitoring strategy best suited to your needs and prepare the plan specifying visit frequency and procedures, supporting effective oversight and compliance with the protocol and regulatory requirements.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong><strong>Quality Plan<\/strong><\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We define quality control and quality assurance strategies and procedures for the entire study, helping maintain the integrity and credibility of the results.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong><strong>Risk management (RBQM)<\/strong><\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We identify the factors that are critical to study quality and develop a risk management plan to guide monitoring and oversight activities, in line with the GCP risk-based approach.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Kick-Off Meeting and Investigators\u2019 Meetings<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We organise kick-off and investigator meetings, key opportunities for communication and alignment among stakeholders, including agenda preparation, presentations and invitations.<\/p><\/div>\n\n<div class=\"wp-block-gutena-tab gutena-tab-block gutena-tab-block-a52ff3-94 inactive\" data-tab=\"5\"><h3 class=\"wp-block-heading has-small-font-size\"><strong>Study website and social media channels<\/strong><\/h3>\n\n<p class=\"has-small-font-size wp-block-paragraph\">We create a dedicated study website and promote it through social media, using recruitment materials submitted to the Ethics Committee, to engage potential participants and stakeholders and support both patient recruitment and retention.<\/p>\n\n<h3 class=\"wp-block-heading has-small-font-size\"><strong>Registration of the study on <a href=\"http:\/\/clinicaltrials.gov\/\">clinicaltrials.gov<\/a><\/strong><\/h3>\n\n<p class=\"wp-block-paragraph\">On behalf of the sponsor, we manage study registration on ClinicalTrials.gov, submitting study information and required updates to make the study publicly accessible to the scientific community.<\/p>\n\n<p class=\"wp-block-paragraph\"><\/p><\/div><\/div><\/div><\/div><style 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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 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.w4i-icon{display:grid;place-items:center;width:48px;height:48px;border-radius:14px;background:var(--w4-teal);color:#fff}\r\n.w4i .w4i-icon svg{width:56%;height:56%}\r\n.w4i .w4i-num{font-size:clamp(2.25rem,1.8rem + 2vw,3.5rem);line-height:1;font-weight:700;color:#fff}\r\n.w4i .w4i-lbl{margin-top:6px;font-size:.95rem;line-height:1.4;color:rgba(255,255,255,.86)}\r\n.w4i .w4i-groups{display:grid;gap:24px}\r\n.w4i .w4i-ghead{display:flex;align-items:center;gap:12px;margin-bottom:14px}\r\n.w4i .w4i-ghead .w4i-icon{width:40px;height:40px;border-radius:12px}\r\n.w4i .w4i-gtitle{font-size:1.05rem;line-height:1.3;font-weight:600;color:#fff}\r\n.w4i .w4i-gcount{font-size:.85rem;line-height:1.3;color:var(--w4-mint)}\r\n.w4i .w4i-chips{display:flex;flex-wrap:wrap;gap:8px}\r\n.w4i .w4i-chip{display:inline-flex;align-items:center;gap:8px;max-width:100%;margin:0;padding:8px 14px;border-radius:999px;background:rgba(255,255,255,.08);border:1px solid 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(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><style id=\"we4cr-faq-css\">.w4f{--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.w4f *,.w4f *::before,.w4f *::after{box-sizing:border-box}\r\n.w4f h2,.w4f h3,.w4f 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*::after{transition:none!important}\r\n}<\/style><div class=\"w4f\" id=\"w4f-1\"><section class=\"w4f-sec w4f-sec--tint\" aria-labelledby=\"w4f-1-faq\"><div class=\"w4f-wrap\"><div class=\"w4f-faq\"><h2 class=\"w4f-h2\" id=\"w4f-1-faq\">People also ask\u2026<\/h2><div class=\"w4f-qa\" data-open-first=\"1\"><div class=\"w4f-qa__item\" data-open=\"1\"><h3 class=\"w4f-qa__h\"><button type=\"button\" class=\"w4f-qa__trigger\" id=\"w4f-1-q-b0\" aria-expanded=\"true\" aria-controls=\"w4f-1-q-p0\"><span class=\"w4f-qa__label\">Does We4CR have the structure to run a study like mine?<\/span><span class=\"w4f-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4f-qa__panel\" id=\"w4f-1-q-p0\" role=\"region\" aria-labelledby=\"w4f-1-q-b0\"><div class=\"w4f-qa__inner\"><p>We have conducted over 55 clinical studies, involving more than 300 hospitals and 600 investigators. The quality management system of We4 Clinical Research for the conduct of clinical studies is ISO 9001:2015 certified, and our processes are aligned with ICH GCP and, for medical devices, with ISO 14155. Every study is followed by a dedicated team: the same people from start to finish.<\/p><\/div><\/div><\/div><div class=\"w4f-qa__item\" data-open=\"1\"><h3 class=\"w4f-qa__h\"><button type=\"button\" class=\"w4f-qa__trigger\" id=\"w4f-1-q-b1\" aria-expanded=\"true\" aria-controls=\"w4f-1-q-p1\"><span class=\"w4f-qa__label\">How are sites selected?<\/span><span class=\"w4f-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4f-qa__panel\" id=\"w4f-1-q-p1\" role=\"region\" aria-labelledby=\"w4f-1-q-b1\"><div class=\"w4f-qa__inner\"><p>We send feasibility questionnaires to potential sites and, based on the responses received, we select those that meet the requirements of the study and the characteristics you are looking for.<\/p><\/div><\/div><\/div><div class=\"w4f-qa__item\" data-open=\"1\"><h3 class=\"w4f-qa__h\"><button type=\"button\" class=\"w4f-qa__trigger\" id=\"w4f-1-q-b2\" aria-expanded=\"true\" aria-controls=\"w4f-1-q-p2\"><span class=\"w4f-qa__label\">Is it better to have a single partner or separate specialists for the study and the regulatory side?<\/span><span class=\"w4f-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4f-qa__panel\" id=\"w4f-1-q-p2\" role=\"region\" aria-labelledby=\"w4f-1-q-b2\"><div class=\"w4f-qa__inner\"><p>With a single team combining clinical and regulatory activities there are fewer handovers: if the protocol changes, the people running the study and those handling the regulatory side already work together to rebuild the context of the project.<\/p><\/div><\/div><\/div><div class=\"w4f-qa__item\" data-open=\"1\"><h3 class=\"w4f-qa__h\"><button type=\"button\" class=\"w4f-qa__trigger\" id=\"w4f-1-q-b3\" aria-expanded=\"true\" aria-controls=\"w4f-1-q-p3\"><span class=\"w4f-qa__label\">How long does Set-up take?<\/span><span class=\"w4f-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4f-qa__panel\" id=\"w4f-1-q-p3\" role=\"region\" aria-labelledby=\"w4f-1-q-b3\"><div class=\"w4f-qa__inner\"><p>It depends on the type of study, the indication, and the number of sites and countries involved. After an initial discovery call, we can outline timelines and steps for your case.<\/p><\/div><\/div><\/div><div class=\"w4f-qa__item\" data-open=\"1\"><h3 class=\"w4f-qa__h\"><button type=\"button\" class=\"w4f-qa__trigger\" id=\"w4f-1-q-b4\" aria-expanded=\"true\" aria-controls=\"w4f-1-q-p4\"><span class=\"w4f-qa__label\">Can I entrust We4CR with Set-up services only?<\/span><span class=\"w4f-qa__ico\" aria-hidden=\"true\"><\/span><\/button><\/h3><div class=\"w4f-qa__panel\" id=\"w4f-1-q-p4\" role=\"region\" aria-labelledby=\"w4f-1-q-b4\"><div class=\"w4f-qa__inner\"><p>Absolutely. Our services are flexible and modular: you can start with Set-up and add other phases to your study when you need them, or entrust us with the study from protocol to close-out. <a class=\"w4f-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\":\"Does We4CR have the structure to run a study like mine?\",\"acceptedAnswer\":{\"@type\":\"Answer\",\"text\":\"We have conducted over 55 clinical studies, involving more than 300 hospitals and 600 investigators. The quality management system of We4 Clinical Research for the conduct of clinical studies is ISO 9001:2015 certified, and our processes are aligned with ICH GCP and, for medical devices, with ISO 14155. 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Discover all our CRO solutions. https:\/\/www.we4cr.com\/solutions\/\"}}]}<\/script><script>(function(){var root=document.getElementById('w4f-1');if(!root){return;}\r\nroot.classList.add('w4f-js');\r\nArray.prototype.forEach.call(root.querySelectorAll('.w4f-qa'),function(list){\r\nvar items=list.querySelectorAll('.w4f-qa__item');\r\nvar openFirst=list.getAttribute('data-open-first')==='1';\r\nfunction setState(item,open){item.setAttribute('data-open',open?'1':'0');item.querySelector('.w4f-qa__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('.w4f-qa__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><div style=\"height:61px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>","protected":false},"excerpt":{"rendered":"<p>By Project Phase Clinical Study Preparation For biotech and pharmaceutical companies, medical device manufacturers, non-profit organizations, and academic institutions launching a clinical study involving drugs or medical devices. During study set-up, we align scientific objectives, regulatory requirements, and operational workflows before the study begins, so it is straightforward to conduct and compliant from the outset. [&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-127","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>What Set-up Activities Include | We4 Clinical Research<\/title>\n<meta name=\"description\" content=\"By Project Phase Clinical Study Preparation 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\/set-up\/\" \/>\n<meta property=\"og:locale\" content=\"it_IT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta 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