{"id":14756,"date":"2022-03-01T07:40:22","date_gmt":"2022-03-01T06:40:22","guid":{"rendered":"https:\/\/www.idisantiago.es\/estudos-clinicos\/"},"modified":"2025-04-09T09:07:07","modified_gmt":"2025-04-09T07:07:07","slug":"estudos-clinicos","status":"publish","type":"page","link":"https:\/\/www.idisantiago.es\/gl\/estudos-clinicos\/","title":{"rendered":"Estudos cl\u00ednicos"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; custom_margin=&#8221;24px||0px||false|false&#8221; custom_padding=&#8221;0px||||false|false&#8221; da_disable_devices=&#8221;off|off|off&#8221; locked=&#8221;on&#8221; collapsed=&#8221;on&#8221; global_colors_info=&#8221;{}&#8221; da_is_popup=&#8221;off&#8221; da_exit_intent=&#8221;off&#8221; da_has_close=&#8221;on&#8221; da_alt_close=&#8221;off&#8221; da_dark_close=&#8221;off&#8221; da_not_modal=&#8221;on&#8221; da_is_singular=&#8221;off&#8221; da_with_loader=&#8221;off&#8221; da_has_shadow=&#8221;on&#8221;][et_pb_row _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; width=&#8221;100%&#8221; custom_padding=&#8221;0px||||false|false&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_post_title meta=&#8221;off&#8221; featured_image=&#8221;off&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][\/et_pb_post_title][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; da_disable_devices=&#8221;off|off|off&#8221; global_colors_info=&#8221;{}&#8221; da_is_popup=&#8221;off&#8221; da_exit_intent=&#8221;off&#8221; da_has_close=&#8221;on&#8221; da_alt_close=&#8221;off&#8221; da_dark_close=&#8221;off&#8221; da_not_modal=&#8221;on&#8221; da_is_singular=&#8221;off&#8221; da_with_loader=&#8221;off&#8221; da_has_shadow=&#8221;on&#8221;][et_pb_row column_structure=&#8221;2_3,1_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; text_font=&#8221;|300|||||||&#8221; global_colors_info=&#8221;{}&#8221;]A investigaci\u00f3n cl\u00ednica aplicada a trav\u00e9s de Estudos Cl\u00ednicos \u00e9 unha das principais \u00e1reas de actividade investigadora do hospital e do Instituto de Investigaci\u00f3n Sanitaria de Santiago de Compostela (IDIS). O noso obxectivo \u00e9 sistematizar e axilizar a execuci\u00f3n de Estudos Cl\u00ednicos, para o que establecemos un procedemento propio para a s\u00faa xesti\u00f3n. O IDIS ofrece soporte \u00e1 posta en marcha e tramitaci\u00f3n de toda a documentaci\u00f3n necesaria para levar a cabo, todos e cada un dos Estudos Cl\u00ednicos non comerciais e comerciais promovidos pola Industria Farmac\u00e9utica nas \u00c1reas Sanitarias de Santiago de Compostela e Barbanza, e de Lugo, A Mari\u00f1a e Monforte de Lemos.<\/p>\n<p>Actuamos como nexo de uni\u00f3n entre Promotores de Estudos Cl\u00ednicos e Investigadores, elaborando contratos, xestionando as diferentes autorizaci\u00f3ns, ditames \u00e9ticos, aspectos de tipo regulamentario e aqueles documentos indispensables para a realizaci\u00f3n deste tipo de Estudos.<\/p>\n<h3>Servizos de apoio ao investigador<\/h3>\n<ul>\n<li>Asesoramento sobre os aspectos regulamentarios, requisitos e documentaci\u00f3n dun estudo de investigaci\u00f3n cl\u00ednica.<\/li>\n<li>Posta en marcha do estudo: solicitudes a CEIC, AEMPS e CCAA. Apoio na preparaci\u00f3n da documentaci\u00f3n.<\/li>\n<li>Outros tr\u00e1mites con CEIC, AEMPS e CCAA: resposta aclaraci\u00f3ns e rectificaci\u00f3ns, presentaci\u00f3n de emendas, ampliaci\u00f3n de centros, notificaci\u00f3n de inicio e fin, env\u00edo de informes anuais\/finais, pago de taxas, etc.<\/li>\n<li>Solicitude orzamentos e contrataci\u00f3n de seguro e CRO.<\/li>\n<li>Coordinaci\u00f3n e xesti\u00f3n de contratos cos centros participantes.<\/li>\n<li>Rexistro de estudos cl\u00ednicos.<\/li>\n<li>Asesoramento \u00f3 persoal do noso Centro Hospitalario sobre a posta en marcha e a xesti\u00f3n de Estudos Cl\u00ednicos promovidos pola Industria Farmac\u00e9utica.<\/li>\n<li>Elaboraci\u00f3n de certificados das Cargas investigadoras dos nosos IP\u2019s.<\/li>\n<li>Seguimento de cada un dos estudos cl\u00ednicos iniciados ata a s\u00faa finalizaci\u00f3n.<\/li>\n<li>Tramitaci\u00f3n de Addendas\/Anexos, de todos os nosos Estudos Cl\u00ednicos.<\/li>\n<li>Custodia e arquivo da documentaci\u00f3n xerada polos investigadores do noso Centro.<\/li>\n<li>Elaboraci\u00f3n de Informe de carga econ\u00f3mica de cada Ensaio Cl\u00ednico, para tramitaci\u00f3n da firma coa Xerencia do Centro.<\/li>\n<li>Direcci\u00f3n do proceso de facturaci\u00f3n tanto para o Centro, como para os nosos IP\u00b4s.<\/li>\n<li>Soporte na Xesti\u00f3n de Firmas co Centro e IP\u00b4s.<\/li>\n<\/ul>\n<h3>Servizos a empresas<\/h3>\n<p>FIDIS ofrece o apoio necesario \u00e1s industrias farmac\u00e9uticas, biotecnol\u00f3xicas, de produtos sanitarios e CRO\u00b4s que pretendan iniciar un Estudo cl\u00ednico nalg\u00fan dos centros da nosa \u00e1rea de xesti\u00f3n.<\/p>\n<p>Somos unha Oficina de alertas que soluciona calquera tipo de cuesti\u00f3n relacionada con contratos, persoal investigador, probas diagn\u00f3sticas, lexislaci\u00f3n aplicable, servizos farmac\u00e9uticos, servizos implicados, cesi\u00f3n de material, pago a enfermos por desprazamentos ou manutenci\u00f3n, calibraci\u00f3n de aparellos e un longo etc\u00e9tera que xurde ao longo de toda a posta en marcha dun Estudo cl\u00ednico:<\/p>\n<ul>\n<li>Identificaci\u00f3n de investigadores e mediador entre promotor e investigador para a posta en marcha do estudo.<\/li>\n<li>Apoio na obtenci\u00f3n da documentaci\u00f3n local (compromiso do IP, idoneidade de instalaci\u00f3ns, etc.).<\/li>\n<li>Direcci\u00f3n do proceso de facturaci\u00f3n a Promotores.<\/li>\n<li>Soporte na xesti\u00f3n de firmas para o Promotor e Xesti\u00f3n de contratos.<\/li>\n<li>Custodia e arquivo da documentaci\u00f3n xerada polos promotores que as\u00ed o pacten nos nosos contratos.<\/li>\n<\/ul>\n<p>[\/et_pb_text][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221;][et_pb_text admin_label=&#8221;Contacto&#8221; _builder_version=&#8221;4.16&#8243; _module_preset=&#8221;default&#8221; text_text_color=&#8221;#FFFFFF&#8221; header_text_color=&#8221;#FFFFFF&#8221; header_2_text_align=&#8221;left&#8221; header_2_text_color=&#8221;#FFFFFF&#8221; background_color=&#8221;#10294c&#8221; custom_margin=&#8221;0px||||false|false&#8221; custom_padding=&#8221;6px||0px|6px|false|false&#8221; locked=&#8221;on&#8221; global_colors_info=&#8221;{}&#8221;]<\/p>\n<h2>Contacto<\/h2>\n<p>[\/et_pb_text][et_pb_text _builder_version=&#8221;4.21.0&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; locked=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p>Loli Willisch Elorduy<br \/>+34 981 955 475 (ext. 255 475)<br \/><a href=\"mailto:loli.willisch.elorduy@sergas.es\">loli.willisch.elorduy@sergas.es<\/a><\/p>\n<p>Teresa Cabaleiro Ocampo<br \/>+34 981 951628 (ext. 251 628)<br \/><a href=\"mailto:ma.teresa.cabaleiro.ocampo@sergas.es\">ma.teresa.cabaleiro.ocampo@sergas.es<\/a><\/p>\n<p>Eva Rial Pensado<br \/>+34 981 955 265 (ext. 255265)<br \/><a href=\"mailto:eva.rial.pensado@sergas.es\">eva.rial.pensado@sergas.es<\/a><\/p>\n<p>Ux\u00eda Blanco Pensado<br \/>+34 981 955263 (ext. 255 263)<br \/><a href=\"mailto:Uxia.Blanco.Pensado@sergas.es\">Uxia.Blanco.Pensado@sergas.es<\/a><\/p>\n<p>Mar\u00eda \u00c1lvarez Satta<br \/>+34 981 955263 (ext. 255 263)<br \/><a href=\"mailto:Maria.Alvarez.Satta@sergas.es\">Maria.Alvarez.Satta@sergas.es\u00a0<\/a><\/p>\n<p>Teresa Bra\u00f1as (Oficina de Lugo)<br \/>+34 982 296 499 (ext. 536 499)<br \/><a href=\"mailto:gestionlugo.fidis@sergas.es\">gestionlugo.fidis@sergas.es<\/a><\/p>\n<p>Eva Alonso (Oficina de Lugo)<br \/>+34 982 296 698 (ext. 536 698)<br \/><a href=\"mailto:investigacionlugo.fidis@sergas.es\">investigacionlugo.fidis@sergas.es<\/a><\/p>\n<div>\u00a0<\/div>\n<p>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; 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[&hellip;]<\/p>\n","protected":false},"author":11,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","inline_featured_image":false,"footnotes":""},"class_list":["post-14756","page","type-page","status-publish","hentry"],"publishpress_future_workflow_manual_trigger":{"enabledWorkflows":[]},"_links":{"self":[{"href":"https:\/\/www.idisantiago.es\/gl\/wp-json\/wp\/v2\/pages\/14756","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.idisantiago.es\/gl\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.idisantiago.es\/gl\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.idisantiago.es\/gl\/wp-json\/wp\/v2\/users\/11"}],"replies":[{"embeddable":true,"href":"https:\/\/www.idisantiago.es\/gl\/wp-json\/wp\/v2\/comments?post=14756"}],"version-history":[{"count":13,"href":"https:\/\/www.idisantiago.es\/gl\/wp-json\/wp\/v2\/pages\/14756\/revisions"}],"predecessor-version":[{"id":39661,"href":"https:\/\/www.idisantiago.es\/gl\/wp-json\/wp\/v2\/pages\/14756\/revisions\/39661"}],"wp:attachment":[{"href":"https:\/\/www.idisantiago.es\/gl\/wp-json\/wp\/v2\/media?parent=14756"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}