{"id":7719,"date":"2020-06-01T13:57:17","date_gmt":"2020-06-01T13:57:17","guid":{"rendered":"https:\/\/www.kolabtree.com\/blog\/?p=7719"},"modified":"2020-06-01T13:57:17","modified_gmt":"2020-06-01T13:57:17","slug":"what-to-look-for-in-a-medical-device-cro","status":"publish","type":"post","link":"https:\/\/www.kolabtree.com\/blog\/pt\/what-to-look-for-in-a-medical-device-cro\/","title":{"rendered":"O que procurar em um CRO de Dispositivo M\u00e9dico"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_45_1 counter-flat ez-toc-counter ez-toc-grey ez-toc-container-direction\">\n<div class=\"ez-toc-title-container\">\n<p class=\"ez-toc-title\">Tabela de Conte\u00fados<\/p>\n<span class=\"ez-toc-title-toggle\"><a href=\"#\" class=\"ez-toc-pull-right ez-toc-btn ez-toc-btn-xs ez-toc-btn-default ez-toc-toggle\" area-label=\"ez-toc-toggle-icon-1\"><label for=\"item-69f26fe31157c\" aria-label=\"Table of Content\"><span style=\"display: flex;align-items: center;width: 35px;height: 30px;justify-content: center;direction:ltr;\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewbox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewbox=\"0 0 24 24\" version=\"1.2\" baseprofile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/label><input  type=\"checkbox\" id=\"item-69f26fe31157c\"><\/a><\/span><\/div>\n<nav><ul class='ez-toc-list ez-toc-list-level-1' ><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/what-to-look-for-in-a-medical-device-cro\/#The_right_expertise\" title=\"A experi\u00eancia certa\u00a0\">A experi\u00eancia certa\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/what-to-look-for-in-a-medical-device-cro\/#Transparency\" title=\"Transpar\u00eancia\u00a0\">Transpar\u00eancia\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/what-to-look-for-in-a-medical-device-cro\/#Experience_with_regulatory_requirements\" title=\"Experi\u00eancia com exig\u00eancias regulat\u00f3rias\u00a0\">Experi\u00eancia com exig\u00eancias regulat\u00f3rias\u00a0<\/a><\/li><li class='ez-toc-page-1'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.kolabtree.com\/blog\/pt\/what-to-look-for-in-a-medical-device-cro\/#When_you_should_work_with_independent_medical_device_consultants\" title=\"Quando voc\u00ea deve trabalhar com consultores independentes de produtos m\u00e9dicos\u00a0\">Quando voc\u00ea deve trabalhar com consultores independentes de produtos m\u00e9dicos\u00a0<\/a><\/li><\/ul><\/nav><\/div>\n<p><i><span style=\"font-weight: 400;\">Outsourcing clinical <a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/ensuring-reproducibility-in-ai-driven-research-how-freelance-experts-can-help-in-biotech-and-healthcare\/\">pesquisa<\/a> to a medical device CRO can be a good decision for small medical device businesses. Here\u2019s what to look for while hiring a medical device CRO or <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-device?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">consultor de dispositivos m\u00e9dicos<\/a>.\u00a0<\/span><\/i><\/p>\n<p><span style=\"font-weight: 400;\">As pequenas e m\u00e9dias empresas de dispositivos m\u00e9dicos muitas vezes n\u00e3o t\u00eam recursos para contratar equipes em tempo integral que possam lidar com todas as complexidades da pesquisa cl\u00ednica de dispositivos m\u00e9dicos. Exig\u00eancias regulamentares, considera\u00e7\u00f5es \u00e9ticas, rotas para aprova\u00e7\u00e3o regulamentar, documentos t\u00e9cnicos: todos eles formam uma parte crucial do processo de pesquisa cl\u00ednica. \u00c9 importante que as empresas de produtos m\u00e9dicos escolham um CRO que tenha tido um bom hist\u00f3rico de sucesso na realiza\u00e7\u00e3o de ensaios cl\u00ednicos e que esteja atualizado com os regulamentos mais recentes em diferentes geografias. Aqui est\u00e3o 3 coisas a serem procuradas durante a terceiriza\u00e7\u00e3o <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-trials?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">pesquisa cl\u00ednica<\/a> a uma CRO.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"The_right_expertise\"><\/span><strong>A experi\u00eancia certa\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Ao escolher um CRO para sua pesquisa, escolha um que tenha experi\u00eancia espec\u00edfica em dispositivos m\u00e9dicos. A CRO j\u00e1 trabalhou com dispositivos m\u00e9dicos de diferentes classes? Eles s\u00e3o especializados em uma classe espec\u00edfica de dispositivo ou em uma \u00e1rea terap\u00eautica espec\u00edfica?\u00a0 <\/span><\/p>\n<p><span style=\"font-weight: 400;\"><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/shrinidh-joshi\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">Shrinidh Joshi,<\/a> consultor em pesquisa cl\u00ednica e <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/medical-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">escritor m\u00e9dico freelance<\/a>\u00a0sobre Kolabtree, diz, \"Muitos CROs s\u00e3o focados em produtos farmac\u00eauticos e carecem de experi\u00eancia suficiente em testes de dispositivos m\u00e9dicos. As empresas de produtos m\u00e9dicos devem identificar este fato no in\u00edcio do processo de avalia\u00e7\u00e3o CRO. Os aspectos operacionais centrais da execu\u00e7\u00e3o de ensaios cl\u00ednicos de produtos farmac\u00eauticos e dispositivos m\u00e9dicos s\u00e3o os mesmos, mas tamb\u00e9m h\u00e1 diferen\u00e7as significativas. Se uma CRO lidou principalmente com os ensaios cl\u00ednicos de produtos farmac\u00eauticos, ent\u00e3o \u00e9 mais do que prov\u00e1vel que sua experi\u00eancia n\u00e3o esteja no espa\u00e7o de dispositivos m\u00e9dicos\".\u00a0<\/span><\/p>\n<p><span style=\"font-weight: 400;\">Ele aconselha: \"As empresas de dispositivos m\u00e9dicos deveriam estar procurando mais do que experi\u00eancia geral em testes de dispositivos m\u00e9dicos em uma CRO. O fornecedor ideal para ensaios cl\u00ednicos de produtos m\u00e9dicos ter\u00e1 demonstrado sucesso na condu\u00e7\u00e3o de pesquisas cl\u00ednicas na \u00e1rea terap\u00eautica do produto e por sua indica\u00e7\u00e3o espec\u00edfica\". Se a CRO trabalhou para projetos de produtos e dispositivos que s\u00e3o similares ao seu dispositivo ou que prev\u00eaem que seria uma CRO ideal\".\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Transparency\"><\/span><strong>Transpar\u00eancia\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">A comunica\u00e7\u00e3o honesta e a transpar\u00eancia s\u00e3o a chave para uma boa rela\u00e7\u00e3o de trabalho. Shrinidh recomenda: \"Ao trabalhar com um CRO, n\u00e3o posso enfatizar o suficiente sobre a import\u00e2ncia da transpar\u00eancia m\u00fatua, confian\u00e7a, honestidade e comunica\u00e7\u00e3o de ambos os lados do relacionamento patrocinador (empresa de produtos m\u00e9dicos) - fornecedor (CRO), come\u00e7ando j\u00e1 na fase de avalia\u00e7\u00e3o.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\"Os patrocinadores devem estar abertos com uma CRO sobre exatamente o que precisam do acordo, quais s\u00e3o suas defini\u00e7\u00f5es de sucesso e fracasso, o que podem pagar e quanto tempo esperam que o trabalho demore. Eles devem ser honestos sobre suas capacidades internas (ou falta delas). Tamb\u00e9m \u00e9 ben\u00e9fico para os patrocinadores comunicarem sua abordagem estrat\u00e9gica de avan\u00e7ar - n\u00e3o apenas na cl\u00ednica, mas tamb\u00e9m nas vendas e comerciais. \u00c9 poss\u00edvel que, dentro da comunidade de dispositivos m\u00e9dicos, o ambiente dos ensaios cl\u00ednicos seja relativamente novo, de modo que os patrocinadores n\u00e3o se sintam necessariamente confort\u00e1veis em compartilhar estrat\u00e9gias de longo prazo, estrat\u00e9gias comerciais ou estrat\u00e9gias de cuidados gerenciados com CROs ou fornecedores. Entretanto, como informante, posso dizer que \u00e9 muito importante que os vendedores compreendam as estrat\u00e9gias de longo prazo dos patrocinadores.<\/span><\/p>\n<p><span style=\"font-weight: 400;\">\"Por outro lado, os patrocinadores devem resistir para um fornecedor que seja franco em rela\u00e7\u00e3o a suas capacidades espec\u00edficas, \u00e1reas de for\u00e7a e fraqueza, servi\u00e7os espec\u00edficos prestados, custos, etc. O alinhamento adequado entre a empresa de produtos m\u00e9dicos e a CRO \u00e9 importante para o sucesso de um ensaio cl\u00ednico com produtos m\u00e9dicos. As vantagens de construir uma rela\u00e7\u00e3o colaborativa e de respeito m\u00fatuo com a sua CRO podem ser significativas\".\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"Experience_with_regulatory_requirements\"><\/span><strong>Experi\u00eancia com exig\u00eancias regulat\u00f3rias\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Ao escolher uma CRO, \u00e9 importante garantir que eles sejam especialistas nas exig\u00eancias regulat\u00f3rias e regras \u00e9ticas que regem a pesquisa cl\u00ednica. Na Europa, as empresas de dispositivos m\u00e9dicos precisam cumprir os Regulamentos de Dispositivos M\u00e9dicos e obter a marca CE, o que lhes permite colocar um produto no mercado da UE. A avalia\u00e7\u00e3o cl\u00ednica constitui uma parte importante do processo, e a manuten\u00e7\u00e3o e atualiza\u00e7\u00e3o de um <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/clinical-evaluation-report-cer\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">relat\u00f3rio de avalia\u00e7\u00e3o cl\u00ednica<\/a> ou CER \u00e9 obrigat\u00f3rio. Como o MDR ainda \u00e9 novo e ainda h\u00e1 alguma incerteza sobre o que exatamente \u00e9 exigido, \u00e9 importante trabalhar com um especialista que tenha experi\u00eancia em escrever CERs especialmente de acordo com a nova regulamenta\u00e7\u00e3o. Nos EUA, o <a href=\"https:\/\/www.fda.gov\/regulatory-information\/search-fda-guidance-documents\/clinical-trials-guidance-documents\">FDA<\/a> rege aspectos da pesquisa cl\u00ednica. Todos os ensaios cl\u00ednicos s\u00e3o <a href=\"https:\/\/www.kolabtree.com\/blog\/how-to-write-a-clinical-trial-protocol\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">necess\u00e1rio para obter a aprova\u00e7\u00e3o da IRB<\/a>que revisa o protocolo de ensaios cl\u00ednicos e assegura que o estudo atenda a considera\u00e7\u00f5es \u00e9ticas. Garanta que voc\u00ea trabalhe com consultores que conhe\u00e7am bem os caminhos da FDA para aprova\u00e7\u00e3o, documentos t\u00e9cnicos, protocolos de ensaios cl\u00ednicos e diretrizes internacionais para a realiza\u00e7\u00e3o de ensaios. Sempre pe\u00e7a exemplos de ensaios cl\u00ednicos com dispositivos m\u00e9dicos nos quais eles j\u00e1 tenham trabalhado antes e certifique-se de que o que eles podem entregar atenda \u00e0s suas expectativas.\u00a0<\/span><\/p>\n<h2><span class=\"ez-toc-section\" id=\"When_you_should_work_with_independent_medical_device_consultants\"><\/span><strong>Quando voc\u00ea deve trabalhar com consultores independentes de produtos m\u00e9dicos\u00a0<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n<p><span style=\"font-weight: 400;\">Dependendo de suas necessidades, voc\u00ea pode considerar trabalhar com consultores independentes, em vez de contratar um CRO completo. Talvez voc\u00ea esteja procurando ajuda com um aspecto muito espec\u00edfico de sua pesquisa: um trabalho de uma s\u00f3 pessoa. Talvez voc\u00ea precise de ajuda com elementos de sua pesquisa cl\u00ednica, como por exemplo: <\/span><span style=\"font-weight: 400;\"><br \/>\n<\/span><\/p>\n<ul>\n<li><span style=\"font-weight: 400;\">Compreender os requisitos regulamentares e\u00a0<\/span><a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/regulatory-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">prepara\u00e7\u00e3o de documentos regulamentares<\/a><\/li>\n<li><span style=\"font-weight: 400;\">Desenvolvimento de um protocolo de ensaios cl\u00ednicos\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Preparando um <a href=\"https:\/\/www.kolabtree.com\/find-an-expert\/subject\/grant-writing\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">pedido de subven\u00e7\u00e3o<\/a> ou proposta de pesquisa\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Realiza\u00e7\u00e3o de an\u00e1lises estat\u00edsticas e verifica\u00e7\u00e3o de resultados\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Avalia\u00e7\u00e3o cl\u00ednica para RCEs (MDR)\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Submiss\u00f5es da FDA\u00a0<\/span><\/li>\n<li><span style=\"font-weight: 400;\">Escrever comunicados de imprensa e desenvolver comunica\u00e7\u00f5es corporativas sobre seu ensaio cl\u00ednico\u00a0<\/span><\/li>\n<\/ul>\n<p><span style=\"font-weight: 400;\">Trabalhar com consultores de produtos m\u00e9dicos sob demanda torna mais f\u00e1cil para voc\u00ea explicar suas exig\u00eancias de forma individualizada e personalizar seus produtos. Voc\u00ea economiza em custos gerais e gastos gerenciais que podem vir com o trabalho com um CRO. Com base na complexidade de seu dispositivo m\u00e9dico e no tipo de suporte que voc\u00ea precisa, voc\u00ea pode escolher a melhor abordagem que o ajude a obter o m\u00e1ximo benef\u00edcio para que voc\u00ea possa lan\u00e7ar seu dispositivo m\u00e9dico com confian\u00e7a. <\/span><span style=\"font-weight: 400;\">\u00a0<\/span><\/p>\n<p><strong>Necessidade de consultar um <a href=\"https:\/\/www.kolabtree.com\/industry\/medical-device\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">especialista em dispositivos m\u00e9dicos<\/a>? Conecte-se com especialistas diretamente em Kolabtree. \u00c9 gr\u00e1tis para postar um projeto e obter cita\u00e7\u00f5es. <a href=\"https:\/\/www.kolabtree.com\/?utm_source=Blog&amp;utm_medium=Post&amp;utm_campaign=MDCRO\">Comece agora<\/a><\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>Outsourcing clinical research to a medical device CRO can be a good decision for small medical device businesses. Here\u2019s what to look for while hiring a medical device CRO or medical device consultant.\u00a0 Small-to-medium-sized medical device companies often don\u2019t have the resources to be able to hire full-time teams who can handle all the complexities<\/p>\n<div class=\"read-more\"><a href=\"https:\/\/www.kolabtree.com\/blog\/pt\/what-to-look-for-in-a-medical-device-cro\/\" title=\"Leia mais\">Leia mais<\/a><\/div>","protected":false},"author":12,"featured_media":7729,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[443,540],"tags":[],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v20.1 (Yoast SEO v20.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>What to look for in a Medical Device CRO - The Kolabtree Blog<\/title>\n<meta name=\"description\" content=\"What to look for when hiring a medical device CRO, including advice from a clinical researcher. Also includes how to save time and costs.\" \/>\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.kolabtree.com\/blog\/pt\/zh\/what-to-look-for-in-a-medical-device-cro\/\" \/>\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"What to look for in a Medical Device CRO\" \/>\n<meta property=\"og:description\" content=\"What to look for when hiring a medical device CRO, including advice from a clinical researcher. 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