{"id":10028,"date":"2025-05-18T17:04:31","date_gmt":"2025-05-18T15:04:31","guid":{"rendered":"https:\/\/scf.incorso.info\/cro\/"},"modified":"2026-10-12T15:50:39","modified_gmt":"2026-10-12T13:50:39","slug":"cro","status":"publish","type":"page","link":"https:\/\/www.essecieffe.it\/en\/cro\/","title":{"rendered":"CRO"},"content":{"rendered":"<section class=\"l-section wpb_row height_custom full_height valign_center color_secondary with_img parallax_ver parallaxdir_reversed\"><div class=\"l-section-img\" role=\"img\" aria-label=\"Image\" data-img-width=\"1920\" data-img-height=\"1269\" style=\"background-image: url(https:\/\/www.essecieffe.it\/wp-content\/uploads\/2025\/06\/bgr3.jpg);\"><\/div><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_grid cols_1 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_top type_default stacking_default\"><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"w-separator size_custom\" style=\"height:25vh\"><\/div><h1 class=\"w-text us_custom_eb849559\"><span class=\"w-text-h\"><span class=\"w-text-value\">Contract Research Organization<\/span><\/span><\/h1><div class=\"w-separator size_custom\" style=\"height:20vh\"><\/div><div class=\"w-iconbox us_custom_99682d72 iconpos_top style_default color_custom align_center no_text no_title\"><a href=\"#accesso\" class=\"w-iconbox-link\" aria-label=\"fas|chevron-down\"><div class=\"w-iconbox-icon\" style=\"font-size:4rem;\"><i class=\"fas fa-chevron-down\"><\/i><\/div><\/a><div class=\"w-iconbox-meta\"><\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row us_custom_432d3f53 height_large\" id=\"accesso\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_grid cols_1-2 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_top type_default stacking_default\"><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column us_custom_eb72c117\"><div class=\"wpb_wrapper\"><p>The CRO team brings strong expertise in designing, conducting, and managing both interventional and observational clinical studies across medicines, medical devices, and dietary supplements.<\/p>\n<\/div><\/div><\/div><\/div><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>SCF is a <strong>CRO<\/strong> committed to supporting sponsors throughout the entire clinical research journey, always ensuring full <em>compliance<\/em> with <em>Good Clinical Practices<\/em> (GCP), ISO 14155, and Ministerial Decree DM 15.11.2011, underpinned by a strong quality system.<\/p>\n<p>From Phase I trials to <em>Real World Evidence<\/em> (RWE) studies, SCF stands as a trusted partner for all stakeholders involved in the design and execution of clinical studies.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row us_custom_432d3f53 height_large\"><div class=\"l-section-overlay\" style=\"background:var(--color-content-bg-alt)\"><\/div><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_grid cols_1-2 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_middle type_default stacking_default\"><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><h2 class=\"w-text us_custom_470d01c9 has_text_color\"><span class=\"w-text-h\"><span class=\"w-text-value\">Clinical Operations<\/span><\/span><\/h2><\/div><\/div><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>At SCF, medical writing is a collaborative effort, working closely with investigators and sponsors to meet the needs of Ethics Committees and regulatory authorities. We support the development of synopses, protocols, Investigator\u2019s Brochures (IB), and all study-specific documents, while handling regulatory submissions and managing the Clinical Trials Information System (CTIS) efficiently and reliably.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row us_custom_432d3f53 height_large\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_grid cols_1-2 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_middle type_default stacking_default\"><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><h2 class=\"w-text us_custom_c061c1bb has_text_color\"><span class=\"w-text-h\"><span class=\"w-text-value\">Monitoring<\/span><\/span><\/h2><\/div><\/div><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Our monitoring activities ensure that every piece of data is accurate, complete, and fully compliant with the protocol and regulations. From the Site Initiation Visit (SIV) to the Close-Out Visit (COV), we oversee the study at every stage, ensuring the proper start of the study, monitoring progress, and a quality-driven conclusion. This proactive approach prevents issues, promote best practices, and delivers results that are both reliable and transparent.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row us_custom_432d3f53 height_large\"><div class=\"l-section-overlay\" style=\"background:var(--color-content-bg-alt)\"><\/div><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_grid cols_1-2 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_middle type_default stacking_default\"><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><h2 class=\"w-text us_custom_ced77b45 has_text_color\"><span class=\"w-text-h\"><span class=\"w-text-value\">Statistics<\/span><\/span><\/h2><\/div><\/div><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Statistical activities start from the study design phase, including sample size determination and the development of the Statistical Analysis Plan (SAP), continue throughout the study, and culminate in data analysis and the preparation of the final statistical report. This comprehensive approach ensures robust, reliable, and high-quality results.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row us_custom_432d3f53 height_large\"><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_grid cols_1-2 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_middle type_default stacking_default\"><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><h2 class=\"w-text us_custom_59940ba7 has_text_color\"><span class=\"w-text-h\"><span class=\"w-text-value\">Clinical Data Management<\/span><\/span><\/h2><\/div><\/div><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>Data collection and management is a crucial aspect of clinical trial documentation, which SCF ensures through Clinical Data Management activities. These include the design of pCRF\/eCRF (FDA 21 CFR Part 11 compliance), the preparation of the Data Validation Plan, query management, and SAE reconciliation.<\/p>\n<p>SCF provides data collection services for clinical trials (Electronic Data Capture\/EDC) with a strong focus on reducing study design timelines\u2014from database development and validation to user training optimization and the implementation of EDC platform phases<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/section><section class=\"l-section wpb_row us_custom_432d3f53 height_large\"><div class=\"l-section-overlay\" style=\"background:var(--color-content-bg-alt)\"><\/div><div class=\"l-section-h i-cf\"><div class=\"g-cols vc_row via_grid cols_1-2 laptops-cols_inherit tablets-cols_inherit mobiles-cols_1 valign_middle type_default stacking_default\"><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><h2 class=\"w-text us_custom_470d01c9 has_text_color\"><span class=\"w-text-h\"><span class=\"w-text-value\">Quality and Audit<\/span><\/span><\/h2><\/div><\/div><div class=\"wpb_column vc_column_container\"><div class=\"vc_column-inner\"><div class=\"wpb_text_column\"><div class=\"wpb_wrapper\"><p>SCF always operates under robust Standard Operating Procedures (SOPs) to ensure that all activities are fully compliant with GCP and regulatory requirements. SCF performs GCP audits following EU Annex 11, ICH E6, and ISO 14155 standards, as well as clinical research audits supporting Phase I\u2013III studies, guaranteeing quality and compliance at every stage.<\/p>\n<\/div><\/div><\/div><\/div><\/div><\/div><\/section>\n","protected":false},"excerpt":{"rendered":"Contract Research OrganizationThe CRO team brings strong expertise in designing, conducting, and managing both interventional and observational clinical studies across medicines, medical devices, and dietary supplements. SCF is a CRO committed to supporting sponsors throughout the entire clinical research journey, always ensuring full compliance with Good Clinical Practices (GCP), ISO 14155, and Ministerial Decree DM...","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-10028","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>CRO - Studio Consulenza Farmacologica<\/title>\n<meta name=\"description\" content=\"Clinical research services for the pharmaceutical and biotech sectors. 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