{"id":5047,"date":"2025-12-05T16:26:14","date_gmt":"2025-12-05T15:26:14","guid":{"rendered":"https:\/\/irccs.com\/divisioni-cliniche\/clinical-research-unit-cru\/"},"modified":"2026-03-26T17:44:01","modified_gmt":"2026-03-26T16:44:01","slug":"clinical-research-unit-cru","status":"publish","type":"medical-area","link":"https:\/\/irccs.com\/en\/divisioni-cliniche\/clinical-research-unit-cru\/","title":{"rendered":"Clinical Research Unit (CRU)"},"content":{"rendered":"\n<h2 class=\"wp-block-heading\"><span  id=\"description\" class=\"h2_anchor\"><\/span>Description<\/h2>\n\n\n\n<p>The Clinical Research Unit (CRU) is the unit within the <a href=\"https:\/\/irccs.com\/en\/divisioni-cliniche\/advanced-clinical-research-and-innovation\/\">Directorate of Clinical Research and Innovation<\/a> that <strong>coordinates all departments and services involved in clinical trials<\/strong>, both profit and nonprofit, in <strong>an integrated manner<\/strong>.<\/p>\n\n\n\n<p>With organizational, management and regulatory expertise, the CRU ensures consistency, quality and continuity at every stage of trials, facilitating collaboration among researchers, sponsors and patients.<br \/><strong>More than 200 clinical trials<\/strong> registered on international platforms <strong>are currently active<\/strong> at the Institute. The types of studies is broad and diverse and includes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Innterventional studies<\/strong>, which evaluate the efficacy and safety of new drugs and therapeutic strategies; studies at different stages of investigational drug development are conducted at the Institute;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Nursing studies<\/strong>, focusing on patient care, quality of life, and management of cancer patients;<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Surgical studies<\/strong>, dedicated to the innovation of surgical techniques and the improvement of postoperative outcomes.<\/li>\n<\/ul>\n\n\n\n<p>Areas of major innovation include trials on Car-T cell therapies, tumor-infiltrating lymphocyte (TIL) therapies, cancer vaccines, radioconjugates, next-generation drugs, and bispecific antibodies and drug-antibody conjugates. These approaches are key to transforming cancer diagnosis and treatment, opening avenues for increasingly personalized and targeted care.<\/p>\n\n\n\n<p>To support these strategies, the Institute is equipped with an <strong>advanced diagnostic service <\/strong>capable of analyzing<strong> over 500 gene variants associated with more than 28 cancer types<\/strong>. This molecular insight allows precise identification of the biological characteristics of each tumor, guiding therapeutic decisions and facilitating patient access to targeted clinical trials and cutting-edge therapies.<\/p>\n\n\n\n<p>Through these efforts, the Institute consolidates its role as a <strong>center of excellence in oncology research<\/strong>, offering patients access to innovative therapies from the earliest stages of testing and contributing significantly to the global advancement of medicine.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span  id=\"mission\" class=\"h2_anchor\"><\/span>Mission<\/h2>\n\n\n\n<p>Ensure <strong>robust, safe and <\/strong>internationally <strong>compliant clinical trial management <\/strong>through a QMS-based organizational model. The approach is based on six principles: commitment, culture, cooperation, patient-centeredness, continuous monitoring and continuous improvement.<\/p>\n\n\n\n<p>The CRU serves as a point of reference for:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Sponsors, CROs and industry partners<\/strong>, for the submission, activation and management of studies.<\/li>\n\n\n\n<li><strong>Researchers and hospital staff<\/strong> to conduct trials.<\/li>\n\n\n\n<li><strong>Patients and caregivers<\/strong>, seeking information on active studies and innovative therapies.<\/li>\n\n\n\n<li><strong>Internal offices<\/strong> for administrative, health and contractual processes.<\/li>\n\n\n\n<li><strong>Ethics committees and regulatory authorities<\/strong>, to ensure full regulatory compliance.<\/li>\n<\/ul>\n\n\n\n<p>With a multidisciplinary team, the CRU supports all phases of clinical trials and strengthens the Institute&#8217;s position as a center of excellence in oncology research.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><span  id=\"equipe\" class=\"h2_anchor\"><\/span>\u00c9quipe<\/h2>\n\n\n\n<p>The <strong>CRU<\/strong> consists of professionals with specialized expertise in clinical research, quality, regulatory affairs, pharmacovigilance, administration, and operational management of studies. The staff includes:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Contacts across macro-areas<\/strong> (QMS, Regulatory, Phase I, Study Management, Pharmacovigilance, Compassionate Use and FPO-promoted Trials)<\/li>\n\n\n\n<li><strong>Data managers<\/strong>, <strong>clinical research coordinators<\/strong> and administrative staff<\/li>\n\n\n\n<li>A<strong> dedicated team for training<\/strong> and internal communication<\/li>\n\n\n\n<li><strong>Experimental physicians and nurses<\/strong><\/li>\n\n\n\n<li><strong>Doctors, nurses, and health care personnel<\/strong> involved in the different studies<\/li>\n<\/ul>\n\n\n\n<p>All staff work according to <strong>up-to-date SOPs<\/strong>, with <strong>ongoing training<\/strong>, in compliance with <strong>Good Clinical Practice (GCP)<\/strong> principles, adopting an approach focused on <strong>efficiency<\/strong>, <strong>transparency<\/strong>, and <strong>continuous improvement<\/strong>, fully aligned with the Institute\u2019s mission.<\/p>\n","protected":false},"featured_media":0,"template":"","meta":{"_acf_changed":false},"class_list":["post-5047","medical-area","type-medical-area","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.2 - 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