{"id":608,"date":"2023-06-06T16:29:22","date_gmt":"2023-06-06T14:29:22","guid":{"rendered":"https:\/\/centrosviluppofarmaci-opbg.it\/attivita-e-assets-eng\/for-research\/"},"modified":"2024-02-12T15:02:27","modified_gmt":"2024-02-12T14:02:27","slug":"for-research","status":"publish","type":"page","link":"https:\/\/centrosviluppofarmaci-opbg.it\/en\/activities-and-assets\/for-research\/","title":{"rendered":"For Researchers"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">Within the OPBG Drug Development Center, the investigator can devote himself completely to the activity of Clinical Research and give priority to the patient-family experience.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The organizational model of the OPBG Drug Development Center provides the researcher with a precise flow that explains how to apply for a Clinical Trial and divides the work between the various professional figures, with specific expertise.<br>This process ensures that the studies performed are highly productive and cost-effective.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Among the assets of the OPBG Drug Development Center available to the investigators, there are the innovative digital systems, such as the CRF (Case Report Form), for non-profit studies and the customized CTMS (Clinical Trial Management System), which provides research teams a complete tool for managing a clinical study during all its phases, creating a digital document archive of the activities that simplifies data and financial management.<\/p>\n\n\n\n<div style=\"height:1rem\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/centrosviluppofarmaci-opbg.it\/en\/start-up-coordination-unit\/\">Link to Start-Up Coordination Unit<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:1em\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/centrosviluppofarmaci-opbg.it\/en\/regulatory-science-unit\/\">Link to Regulatory Science Unit<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:1em\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-fill\"><a class=\"wp-block-button__link wp-element-button\" href=\"https:\/\/centrosviluppofarmaci-opbg.it\/en\/clinical-trial-quality-team\/\">Link to CTQT<\/a><\/div>\n<\/div>\n\n\n\n<div style=\"height:2em\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"wp-block-group is-style-full-bg form-study-container\"><div class=\"wp-block-group__inner-container\">\n<div class=\"wp-block-contact-form-7-contact-form-selector form-study\">\n<div class=\"wpcf7 no-js\" id=\"wpcf7-f1599-o1\" lang=\"en-US\" dir=\"ltr\" data-wpcf7-id=\"1599\">\n<div class=\"screen-reader-response\"><p role=\"status\" aria-live=\"polite\" aria-atomic=\"true\"><\/p> <ul><\/ul><\/div>\n<form action=\"\/en\/wp-json\/wp\/v2\/pages\/608#wpcf7-f1599-o1\" method=\"post\" class=\"wpcf7-form init\" aria-label=\"Contact form\" enctype=\"multipart\/form-data\" novalidate=\"novalidate\" data-status=\"init\">\n<fieldset class=\"hidden-fields-container\"><input type=\"hidden\" name=\"_wpcf7\" value=\"1599\" \/><input type=\"hidden\" name=\"_wpcf7_version\" value=\"6.1.6\" \/><input type=\"hidden\" name=\"_wpcf7_locale\" value=\"en_US\" \/><input type=\"hidden\" name=\"_wpcf7_unit_tag\" value=\"wpcf7-f1599-o1\" \/><input type=\"hidden\" name=\"_wpcf7_container_post\" value=\"0\" \/><input type=\"hidden\" name=\"_wpcf7_posted_data_hash\" value=\"\" \/><input type=\"hidden\" name=\"_wpcf7cf_hidden_group_fields\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_hidden_groups\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_visible_groups\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_repeaters\" value=\"[]\" \/><input type=\"hidden\" name=\"_wpcf7cf_steps\" value=\"{}\" \/><input type=\"hidden\" name=\"_wpcf7cf_options\" value=\"{&quot;form_id&quot;:1599,&quot;conditions&quot;:[],&quot;settings&quot;:{&quot;animation&quot;:&quot;yes&quot;,&quot;animation_intime&quot;:200,&quot;animation_outtime&quot;:200,&quot;conditions_ui&quot;:&quot;normal&quot;,&quot;notice_dismissed&quot;:false,&quot;repeater_remove_button&quot;:&quot;bottom&quot;,&quot;notice_dismissed_rollback-cf7-5.8.6&quot;:true}}\" \/>\n<\/fieldset>\n<h3>No Profit Clinical Study Proposal<\/h3>\n<p class=\"form-description\">\n(please provide all relevant information available)\n<\/p>\n<div class=\"row\">\n  <div class=\"col-md-6\">\n    <div class=\"form-floating\">\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-opbg-area\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" id=\"csf-opbg-area\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-opbg-area\" \/><\/span>\n     <label for=\"csf-opbg-area\">OPBG Research Area<\/label>\n    <\/div>\n  <\/div>\n  <div class=\"col-md-6\">\n    <div class=\"form-floating\">\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-opbg-unit\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" id=\"csf-opbg-unit\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-opbg-unit\" \/><\/span>\n     <label for=\"csf-opbg-unit\">OPBG Research Unit<\/label>\n    <\/div>\n  <\/div>\n  <div class=\"col-md-6\">\n    <div class=\"form-floating\">\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-sponsor\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" id=\"csf-sponsor\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-sponsor\" \/><\/span>\n     <label for=\"csf-sponsor\">Sponsor (OPBG or External)<\/label>\n    <\/div>\n  <\/div>\n  <div class=\"col-md-6\">\n    <div class=\"form-floating\">\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-investigator\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" id=\"csf-investigator\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-investigator\" \/><\/span>\n     <label for=\"csf-investigator\">Principal Investigator<\/label>\n    <\/div>\n  <\/div>\n  <div class=\"col-md-6\">\n    <div class=\"form-floating\">\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-contact\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" id=\"csf-contact\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-contact\" \/><\/span>\n     <label for=\"csf-contact\">Contact person (Please specify if different from PI)<\/label>\n    <\/div>\n  <\/div>\n  <div class=\"col-md-6\">\n    <div class=\"form-floating\">\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-contact-email\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" id=\"csf-contact-email\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-contact-email\" \/><\/span>\n     <label for=\"csf-contact-email\">Contact person e-mail<\/label>\n    <\/div>\n  <\/div>\n  <div class=\"col-md-6\">\n    <div class=\"form-floating\">\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-contact-phone\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" id=\"csf-contact-phone\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-contact-phone\" \/><\/span>\n     <label for=\"csf-contact-phone\">Contact person phone<\/label>\n    <\/div>\n  <\/div>\n  <div class=\"col-md-6\">\n    <div class=\"form-floating\">\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-project-title\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" id=\"csf-project-title\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-project-title\" \/><\/span>\n     <label for=\"csf-project-title\">Project Title<\/label>\n    <\/div>\n  <\/div>\n  <div class=\"col-md-6\">\n    <div class=\"form-floating\">\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-therapeutic-area\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" id=\"csf-therapeutic-area\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-therapeutic-area\" \/><\/span>\n     <label for=\"csf-therapeutic-area\">Therapeutic Area<\/label>\n    <\/div>\n  <\/div>\n  <div class=\"col-md-6\">\n    <div class=\"form-floating\">\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-disease\"><input size=\"40\" maxlength=\"400\" class=\"wpcf7-form-control wpcf7-text wpcf7-validates-as-required form-control\" id=\"csf-disease\" aria-required=\"true\" aria-invalid=\"false\" value=\"\" type=\"text\" name=\"your-disease\" \/><\/span>\n     <label for=\"csf-disease\">Disease to be addressed<\/label>\n    <\/div>\n  <\/div>\n  <div class=\"col-md-6 radio-block\">\n   <label>Type and Phase of the study<\/label>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-type-phase\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"your-type-phase\" value=\"Disease Registry\" \/><span class=\"wpcf7-list-item-label\">Disease Registry<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"your-type-phase\" value=\"Observational Study\" \/><span class=\"wpcf7-list-item-label\">Observational Study<\/span><\/label><\/span><\/span><\/span>\n     <div data-id=\"observe-study\" data-orig_data_id=\"observe-study\"  class=\"ps-2\" data-class=\"wpcf7cf_group\"><span class=\"wpcf7-form-control-wrap\" data-name=\"your-type-phase-1\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"your-type-phase-1\" value=\"Retrospective\" \/><span class=\"wpcf7-list-item-label\">Retrospective<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"your-type-phase-1\" value=\"Prospective\" \/><span class=\"wpcf7-list-item-label\">Prospective<\/span><\/label><\/span><\/span><\/span><\/div>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-type-phase\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first last\"><label><input type=\"radio\" name=\"your-type-phase\" value=\"Interventional study\" \/><span class=\"wpcf7-list-item-label\">Interventional study<\/span><\/label><\/span><\/span><\/span>\n     <div data-id=\"interventional-study\" data-orig_data_id=\"interventional-study\"  class=\"ps-2\" data-class=\"wpcf7cf_group\"><span class=\"wpcf7-form-control-wrap\" data-name=\"your-type-phase-1\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"your-type-phase-1\" value=\"Low interventional Study*\" \/><span class=\"wpcf7-list-item-label\">Low interventional Study*<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"your-type-phase-1\" value=\"New Indication\" \/><span class=\"wpcf7-list-item-label\">New Indication<\/span><\/label><\/span><\/span><\/span><\/div>\n     <div data-id=\"new-indication\" data-orig_data_id=\"new-indication\"  class=\"ps-4\" data-class=\"wpcf7cf_group\"><span class=\"wpcf7-form-control-wrap\" data-name=\"your-type-phase-2\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"your-type-phase-2\" value=\"First in human\/children Phase 1\" \/><span class=\"wpcf7-list-item-label\">First in human\/children Phase 1<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"your-type-phase-2\" value=\"PK\/dose finding\" \/><span class=\"wpcf7-list-item-label\">PK\/dose finding<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"your-type-phase-2\" value=\"Safety\" \/><span class=\"wpcf7-list-item-label\">Safety<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"your-type-phase-2\" value=\"Efficacy\" \/><span class=\"wpcf7-list-item-label\">Efficacy<\/span><\/label><\/span><\/span><\/span><\/div>\n     <div data-id=\"interventional-study\" data-orig_data_id=\"interventional-study\"  class=\"ps-2\" data-class=\"wpcf7cf_group\"><span class=\"wpcf7-form-control-wrap\" data-name=\"your-type-phase-1\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"your-type-phase-1\" value=\"Approved Indication (Phase 4)\" \/><span class=\"wpcf7-list-item-label\">Approved Indication (Phase 4)<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"your-type-phase-1\" value=\"Diagnostic Study\" \/><span class=\"wpcf7-list-item-label\">Diagnostic Study<\/span><\/label><\/span><\/span><\/span><\/div>\n  <\/div>\n  <div class=\"col-md-6\">\n    <div class=\"mb-2 radio-block\">\n       <label>Type and Phase of the study<\/label>\n       <span class=\"wpcf7-form-control-wrap\" data-name=\"your-type-phase-second\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"your-type-phase-second\" value=\"Single arm study\" \/><span class=\"wpcf7-list-item-label\">Single arm study<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"your-type-phase-second\" value=\"Active controlled not-randomised study\" \/><span class=\"wpcf7-list-item-label\">Active controlled not-randomised study<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"your-type-phase-second\" value=\"Active controlled randomised study\" \/><span class=\"wpcf7-list-item-label\">Active controlled randomised study<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"your-type-phase-second\" value=\"Placebo controlled randomised study\" \/><span class=\"wpcf7-list-item-label\">Placebo controlled randomised study<\/span><\/label><\/span><\/span><\/span>\n    <\/div>\n    <div class=\"mb-2 radio-block\">\n   <label>Intervention<\/label>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-intervention\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first last\"><label><input type=\"radio\" name=\"your-intervention\" value=\"Investigational Medical Product\" \/><span class=\"wpcf7-list-item-label\">Investigational Medical Product<\/span><\/label><\/span><\/span><\/span>\n     <div data-id=\"intervention-investigate\" data-orig_data_id=\"intervention-investigate\"  class=\"ps-2\" data-class=\"wpcf7cf_group\">\n       <span class=\"wpcf7-form-control-wrap\" data-name=\"your-intervention-1\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"your-intervention-1\" value=\"Chemicals medicine\" \/><span class=\"wpcf7-list-item-label\">Chemicals medicine<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"your-intervention-1\" value=\"Biologic medicine\" \/><span class=\"wpcf7-list-item-label\">Biologic medicine<\/span><\/label><\/span><span class=\"wpcf7-list-item\"><label><input type=\"radio\" name=\"your-intervention-1\" value=\"Vaccine\" \/><span class=\"wpcf7-list-item-label\">Vaccine<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"your-intervention-1\" value=\"Advanced therapy medicinal products (ATMPs) (gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines)\" \/><span class=\"wpcf7-list-item-label\">Advanced therapy medicinal products (ATMPs) (gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines)<\/span><\/label><\/span><\/span><\/span>\n     <\/div>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-intervention\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"your-intervention\" value=\"Medical Device\" \/><span class=\"wpcf7-list-item-label\">Medical Device<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"your-intervention\" value=\"Any other please indicate\" \/><span class=\"wpcf7-list-item-label\">Any other please indicate<\/span><\/label><\/span><\/span><\/span>\n     <\/div>\n  <\/div>\n  <div class=\"col-md-12\">\n    <div class=\"mb-2 bt-1\">\n     <label>Does your proposal have financial support?<\/label>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-financial-support\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"your-financial-support\" value=\"YES\" \/><span class=\"wpcf7-list-item-label\">YES<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"your-financial-support\" value=\"NO\" \/><span class=\"wpcf7-list-item-label\">NO<\/span><\/label><\/span><\/span><\/span>\n    <\/div>\n  <\/div>\n<div data-id=\"financial-support-specs\" data-orig_data_id=\"financial-support-specs\"  class=\"ps-2\" data-class=\"wpcf7cf_group\">\n<div class=\"col-md-12\">\n    <div class=\"mb-2 bt-1\">\n     <label>Which type?<\/label>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-financial-support-type\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"your-financial-support-type\" value=\"Internal\" \/><span class=\"wpcf7-list-item-label\">Internal<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"your-financial-support-type\" value=\"External\" \/><span class=\"wpcf7-list-item-label\">External<\/span><\/label><\/span><\/span><\/span>\n    <\/div>\n  <\/div>\n<div class=\"col-md-12\">\n    <div class=\"mb-2 bt-1\">\n     <label>Which amount?<\/label>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-financial-support-amount\"><textarea cols=\"40\" rows=\"10\" maxlength=\"1000\" class=\"wpcf7-form-control wpcf7-textarea form-control\" aria-invalid=\"false\" name=\"your-financial-support-amount\"><\/textarea><\/span>\n    <\/div>\n  <\/div>\n<\/div>\n  <div class=\"col-md-12\">\n    <div class=\"mb-2 bt-1\">\n     <label>Would you like to have a methodological\/regulatory support from Clinical Trial Quality Team?<\/label>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-support\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first\"><label><input type=\"radio\" name=\"your-support\" value=\"YES\" \/><span class=\"wpcf7-list-item-label\">YES<\/span><\/label><\/span><span class=\"wpcf7-list-item last\"><label><input type=\"radio\" name=\"your-support\" value=\"NO\" \/><span class=\"wpcf7-list-item-label\">NO<\/span><\/label><\/span><\/span><\/span>\n    <\/div>\n  <\/div>\n  <div class=\"col-md-12\">\n    <div class=\"mb-2 bt-1 radio-block\">\n     <label>Are the study synopsis and\/or protocol and\/or preliminary schedule of assessment of study available?<\/label>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-file-available\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first last\"><label><input type=\"radio\" name=\"your-file-available\" value=\"YES\" \/><span class=\"wpcf7-list-item-label\">YES<\/span><\/label><\/span><\/span><\/span>\n     <small>If yes, please provide it\/them<\/small>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-file-available\"><span class=\"wpcf7-form-control wpcf7-radio\"><span class=\"wpcf7-list-item first last\"><label><input type=\"radio\" name=\"your-file-available\" value=\"NO\" \/><span class=\"wpcf7-list-item-label\">NO<\/span><\/label><\/span><\/span><\/span>\n     <small>If no, please complete the following fields:<\/small>\n    <\/div>\n  <\/div>\n  <div data-id=\"no-file-available\" data-orig_data_id=\"no-file-available\"  class=\"bt-1\" data-class=\"wpcf7cf_group\">\n   <div class=\"col-md-12\">\n    <div class=\"mb-2\">\n     <label>BACKGROUND \u2013 RATIONALE <span class=\"fw-light\">(max 1.000 characters including space)<\/span><\/label>\n      <small><i>Please describe an updated review of already available evidence in the relevant literature with reference to disease, available treatment and therapeutic regimen information on which the study is focused.\nFurthermore, indication of the main hypothesis to be tested should be provided. Please list 3-5 relevant publications (i.e. Systematic review, review, guidelines).<\/i><\/small>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-rationale\"><textarea cols=\"40\" rows=\"10\" maxlength=\"1000\" class=\"wpcf7-form-control wpcf7-textarea form-control\" aria-invalid=\"false\" name=\"your-rationale\"><\/textarea><\/span>\n    <\/div>\n   <\/div>\n   <div class=\"col-md-12\">\n    <div class=\"mb-2\">\n     <label>OBJECTIVES OF THE STUDY <span class=\"fw-light\">(max 1.000 characters)<\/span><\/label>\n      <small><i>The purpose of the study, the primary objective, the secondary objectives, what the research add to the scientific knowledge, and impact\/therapeutic benefit foreseen.<\/i><\/small>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-study-target\"><textarea cols=\"40\" rows=\"10\" maxlength=\"1000\" class=\"wpcf7-form-control wpcf7-textarea form-control\" aria-invalid=\"false\" name=\"your-study-target\"><\/textarea><\/span>\n    <\/div>\n   <\/div>\n   <div class=\"col-md-12\">\n    <div class=\"mb-2\">\n     <label>STUDY DESIGN <span class=\"fw-light\">(max 1.000 characters)<\/span><\/label>\n      <small><i>Please describe the study design based on the questions, which are the object of the study proposal, phase of clinical trial, study organization; if controlled or not controlled; if superiority, equivalence or noninferiority is expected.<\/i><\/small>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-study-design\"><textarea cols=\"40\" rows=\"10\" maxlength=\"1000\" class=\"wpcf7-form-control wpcf7-textarea form-control\" aria-invalid=\"false\" name=\"your-study-design\"><\/textarea><\/span>\n    <\/div>\n   <\/div>\n   <div class=\"col-md-12\">\n    <div class=\"mb-2\">\n     <label>STUDY POPULATION <span class=\"fw-light\">(max 1.000 characters)<\/span><\/label>\n      <small><i>Please describe the population to be included into this study specifying prevalence in the general population (cases over 10.000) and, if possible, inclusion and exclusion criteria. Please indicate how many patients with these criteria are followed in one year within your department.<\/i><\/small>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-study-population\"><textarea cols=\"40\" rows=\"10\" maxlength=\"1000\" class=\"wpcf7-form-control wpcf7-textarea form-control\" aria-invalid=\"false\" name=\"your-study-population\"><\/textarea><\/span>\n    <\/div>\n   <\/div>\n   <div class=\"col-md-12\">\n    <div class=\"mb-2\">\n     <label>INTERVENTION <span class=\"fw-light\">(max 1.000 characters)<\/span><\/label>\n      <small>\u2022 Dose and dosage form<br\/>\n\u2022 Route of administration<br\/>\n\u2022 Duration of treatment<br\/>\n\u2022 Available on the market and if yes for which indication<\/small>\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-intervention\"><textarea cols=\"40\" rows=\"10\" maxlength=\"1000\" class=\"wpcf7-form-control wpcf7-textarea form-control\" aria-invalid=\"false\" name=\"your-intervention\"><\/textarea><\/span>\n    <\/div>\n   <\/div>\n  <\/div>\n  <div class=\"col-md-12\">\n    <a class=\"btn btn-link\" href=\"https:\/\/centrosviluppofarmaci-opbg.it\/wp-content\/uploads\/2024\/10\/esempio-schedule-of-assessments.docx\" title=\"FAC-SIMILE\" download>\n       <svg class=\"icon\"><use xlink:href=\"https:\/\/centrosviluppofarmaci-opbg.it\/wp-content\/themes\/csf\/assets\/dist\/svg\/sprite-icon.svg#icon-download\"><\/use><\/svg> \n       <span>Scarica il FAC-SIMILE Preliminary Schedule of assessment of Study<\/span>\n    <\/a>\n  <\/div>\n<div data-id=\"group-study-synopsis\" data-orig_data_id=\"group-study-synopsis\"  class=\"\" data-class=\"wpcf7cf_group\">\n<div class=\"col-md-12\">\n    <span class=\"btn btn-link btn-inputfile\"> Upload study synopsis\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-study-synopsis\"><input size=\"40\" class=\"wpcf7-form-control wpcf7-file form-control\" id=\"csf-study-synopsis\" accept=\".doc,.pdf,.jpg\" aria-invalid=\"false\" type=\"file\" name=\"your-study-synopsis\" \/><\/span>\n     <\/span>\n  <\/div>\n<div class=\"col-md-12\">\n    <span class=\"btn btn-link btn-inputfile\"> Upload study protocol\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-study-protocol\"><input size=\"40\" class=\"wpcf7-form-control wpcf7-file form-control\" id=\"csf-study-protocol\" accept=\".doc,.pdf,.jpg\" aria-invalid=\"false\" type=\"file\" name=\"your-study-protocol\" \/><\/span>\n     <\/span>\n  <\/div>\n<div class=\"col-md-12\">\n    <span class=\"btn btn-link btn-inputfile\"> Carica il Preliminary Schedule of assessment of study\n     <span class=\"wpcf7-form-control-wrap\" data-name=\"your-preliminary-schedule\"><input size=\"40\" class=\"wpcf7-form-control wpcf7-file form-control\" id=\"csf-cv\" accept=\".doc,.pdf,.jpg\" aria-invalid=\"false\" type=\"file\" name=\"your-preliminary-schedule\" \/><\/span>\n     <\/span>\n  <\/div>\n<\/div>\n<\/div>\n<div class=\"form-check\">\n<span class=\"wpcf7-form-control-wrap\" data-name=\"your-privacy\"><span class=\"wpcf7-form-control wpcf7-acceptance\"><span class=\"wpcf7-list-item\"><label><input type=\"checkbox\" name=\"your-privacy\" value=\"1\" class=\"form-check-input\" aria-invalid=\"false\" \/><span class=\"wpcf7-list-item-label\"><label class=\"form-check-label\">Accetto i termini della <a href=\"https:\/\/centrosviluppofarmaci-opbg.it\/privacy-e-cookie-policy\/\" target=\"_blank\">Privacy policy<\/a><\/label><\/span><\/label><\/span><\/span><\/span>\n<\/div>\n<div class=\"form-actions\">\n<button class=\"btn btn-success ms-auto\"><input class=\"wpcf7-form-control wpcf7-submit has-spinner\" type=\"submit\" value=\"Invia la tua idea\" \/><\/button>\n<\/div>\n\n<div class=\"form-notes\">\n<p>\n*As per New EU Regulation 536\/2014: \u2018Low-intervention clinical trial\u2019 means a clinical trial which fulfils all of the following conditions:<br\/>\n(a) the investigational medicinal products, excluding placebos, are authorised;<br\/>\n(b) according to the protocol of the clinical trial;<br\/>\n(i) the investigational medicinal products are used in accordance with the terms of the marketing\nauthorisation;<br\/>\n(ii) the use of the investigational medicinal products is evidence-based and supported by published\nscientific evidence on the safety and efficacy of those investigational medicinal products in any of the\nMember States concerned;<br\/>\n(c) the additional diagnostic or monitoring procedures do not pose more than minimal additional risk or\nburden to the safety of the subjects compared to normal clinical practice in any Member State concerned;<\/p><\/div><div class=\"wpcf7-response-output\" aria-hidden=\"true\"><\/div>\n<\/form>\n<\/div>\n<\/div>\n<\/div><\/div>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n<div class=\"contact-block\">\n\t<svg class=\"icon\"><use xlink:href=\"https:\/\/centrosviluppofarmaci-opbg.it\/wp-content\/themes\/csf\/assets\/dist\/svg\/sprite-icon.svg#icon-evenlope\"><\/use><\/svg>\n    \n\n<h2 class=\"wp-block-heading\">Contacts<\/h2>\n\n\n\n<p class=\"wp-block-paragraph\"><\/p>\n\n\n\n<div class=\"wp-block-group\"><div class=\"wp-block-group__inner-container\">\n<p class=\"wp-block-paragraph\">giulia.neccia@opbg.net<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">06 6859 3075<\/p>\n<\/div><\/div>\n\n\n<\/div>\n\n\n\n<div style=\"height:100px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Within the OPBG Drug Development Center, the investigator can devote himself completely to the activity of Clinical Research and give priority to the patient-family experience. The organizational model of the OPBG Drug Development Center provides the researcher with a precise flow that explains how to apply for a Clinical Trial and divides the work between [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":598,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-608","page","type-page","status-publish","hentry"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.7 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>For Researchers - Centro Sviluppo Farmaci<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/centrosviluppofarmaci-opbg.it\/en\/activities-and-assets\/for-research\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"For Researchers - Centro Sviluppo Farmaci\" \/>\n<meta property=\"og:description\" content=\"Within the OPBG Drug Development Center, the investigator can devote himself completely to the activity of Clinical Research and give priority to the patient-family experience. 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