{"id":25496,"date":"2024-05-14T10:32:24","date_gmt":"2024-05-14T14:32:24","guid":{"rendered":"https:\/\/staging.systech.ssdev.ca\/products\/traceability-new-unitrace-2\/"},"modified":"2025-11-21T08:41:52","modified_gmt":"2025-11-21T13:41:52","slug":"clinical-trials-for-imps","status":"publish","type":"page","link":"https:\/\/staging.systech.ssdev.ca\/pt\/solutions\/regulatory-compliance\/clinical-trials-for-imps\/","title":{"rendered":"Ensaios cl\u00ednicos para MEs"},"content":{"rendered":"
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Casa<\/a><\/span><\/span><\/p>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Garantir a precis\u00e3o dos r\u00f3tulos dos medicamentos experimentais de ensaios cl\u00ednicos<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Atender aos rigorosos requisitos de rotulagem associados a ensaios cl\u00ednicos<\/strong> para medicamentos experimentais<\/span><\/span> (IMPs<\/strong>)<\/span><\/span>\u00a0com precis\u00e3o e agilidade.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Solu\u00e7\u00e3o flex\u00edvel, tudo em um<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Impress\u00e3o e verifica\u00e7\u00e3o de etiquetas para medicamentos experimentais (MEs)<\/strong> usados em estudos cl\u00ednicos \u00e9 um desafio. Mas com a seguran\u00e7a dos participantes, a conformidade regulat\u00f3ria, as necessidades de rastreamento e a integridade dos dados do estudo cl\u00ednico em jogo, n\u00e3o h\u00e1 espa\u00e7o para erros de rotulagem.<\/p>

As normas de rotulagem da UE para medicamentos experimentais (MEs) usados em estudos cl\u00ednicos s\u00e3o rigorosas. A conformidade com elas pode ser complexa e dispendiosa devido aos diversos fatores que podem afetar o conte\u00fado do r\u00f3tulo. Entre eles: o projeto, a fase e o local do estudo cl\u00ednico; altera\u00e7\u00f5es na dosagem, datas de validade e outros componentes do r\u00f3tulo que surgem entre ou durante os estudos cl\u00ednicos; e requisitos de idioma espec\u00edficos do pa\u00eds.\u00a0<\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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O <\/span>Marca\u00e7\u00e3o e verifica\u00e7\u00e3o manual T11<\/span><\/b><\/a>,<\/span> parte da linha Systech\/PCE de solu\u00e7\u00f5es de rastreamento e monitoramento, ajuda a superar os desafios com uma solu\u00e7\u00e3o econ\u00f4mica e completa para impress\u00e3o e verifica\u00e7\u00e3o de r\u00f3tulos para MEs usados em estudos cl\u00ednicos. Flex\u00edvel, adapt\u00e1vel e confi\u00e1vel, ele garante que todas as informa\u00e7\u00f5es necess\u00e1rias do r\u00f3tulo estejam presentes, leg\u00edveis e precisas, ajudando a manter a seguran\u00e7a do sujeito e a integridade dos dados e a atender aos requisitos de conformidade.<\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tTUDO EM UM\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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\n\t\t\t\t\t\t\n\t\t\t\t\t\t\tFLEX\u00cdVEL\t\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/h3>\n\t\t\t\t\n\t\t\t\t\n\t\t\t<\/div>\n\t\t\t\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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Quando o tamanho \u00e9 importante <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Embora os tamanhos dos lotes de etiquetas de ME possam aumentar de uma fase cl\u00ednica para outra, eles ainda s\u00e3o normalmente pequenos. As altera\u00e7\u00f5es frequentes no conte\u00fado das etiquetas geralmente exigem a impress\u00e3o e a verifica\u00e7\u00e3o just-in-time necess\u00e1rias. <\/span>\u00a0<\/span><\/p>

Considera\u00e7\u00f5es de custo, uso limitado e espa\u00e7o insuficiente tornam impratic\u00e1vel o investimento em um sistema de etiquetagem em larga escala no local. A terceiriza\u00e7\u00e3o da produ\u00e7\u00e3o e da verifica\u00e7\u00e3o de etiquetas ou a vincula\u00e7\u00e3o de um sistema local existente para pequenas tiragens pode ser cara e ineficiente.<\/span>\u00a0<\/span><\/p>

A T11 oferece uma alternativa econ\u00f4mica. Ela integra impress\u00e3o \u00e1gil e recursos de verifica\u00e7\u00e3o precisos em uma solu\u00e7\u00e3o \u00fanica e multiuso.\u00a0<\/span>\u00a0<\/span><\/p>

Com um design ergon\u00f4mico e que economiza espa\u00e7o, o T11 pode ser usado em ambientes pequenos e confinados. Ele cabe em uma mesa ou em um carrinho, de modo que pode ser facilmente transportado para diferentes locais, conforme necess\u00e1rio. Ele tamb\u00e9m oferece recursos que permitem que seja usado para serializa\u00e7\u00e3o de r\u00f3tulos para rastrear e acompanhar os MEs durante todo o ciclo de vida do estudo cl\u00ednico, bem como para rotulagem de MEs.<\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Favor\u00e1vel \u00e0 CTR da UE <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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A flexibilidade do T11 permite que ele imprima e verifique rapidamente o conte\u00fado da etiqueta. Isso inclui os requisitos de etiquetas IMP especificados na <\/span>Regulamento de Ensaios Cl\u00ednicos da Uni\u00e3o Europeia 536\/2014 (EU CTR)<\/span><\/a>que entrou em vigor no final de janeiro de 2022 e substitui o <\/span>Diretiva de Ensaios Cl\u00ednicos da Uni\u00e3o Europeia (EU CTD) 2001\/20\/EC<\/span><\/a>.<\/span>\u00a0<\/span><\/p>

Os ensaios cl\u00ednicos apresentados sob o CTR da UE devem estar em conformidade com os novos requisitos. Os ensaios cl\u00ednicos existentes autorizados sob o EU CTD podem manter sua rotulagem original.O T11 pode acomodar qualquer estrutura regulat\u00f3ria aplic\u00e1vel, bem como quaisquer altera\u00e7\u00f5es de r\u00f3tulo que surjam.\u00a0<\/span>\u00a0<\/span><\/p>

Ele suporta formatos vari\u00e1veis para lidar com o conte\u00fado exato que deve aparecer nos r\u00f3tulos de IMP. Basta fornecer o conte\u00fado aprovado da etiqueta em conformidade com o EU CTR, que \u00e9 atribu\u00eddo dinamicamente aos modelos de PDF. \u00c0 medida que as etiquetas s\u00e3o impressas, a c\u00e2mera integrada da T11 verifica sua precis\u00e3o em rela\u00e7\u00e3o ao PDF aprovado.<\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Adaptabilidade espec\u00edfica do pa\u00eds <\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Embora a CTR da UE padronize a maior parte do conte\u00fado dos r\u00f3tulos dos MEs usados em estudos cl\u00ednicos, os r\u00f3tulos devem ser escritos no idioma local do centro do estudo, bem como em qualquer idioma adicional exigido pelas regulamenta\u00e7\u00f5es locais. Os r\u00f3tulos dos MEs usados em estudos cl\u00ednicos que ainda estejam operando sob a DTC da UE tamb\u00e9m podem estar sujeitos a outros requisitos locais ou espec\u00edficos do pa\u00eds.<\/span>\u00a0<\/span><\/p>

O T11 pode se adaptar rapidamente aos requisitos de rotulagem de pa\u00edses individuais, bem como de locais de ensaios cl\u00ednicos. Tudo o que \u00e9 necess\u00e1rio \u00e9 uma prova em PDF do r\u00f3tulo aprovado pelo cliente.\u00a0<\/span>\u00a0<\/span><\/p>

A T11 tamb\u00e9m pode ser executada no modo de descolamento para impress\u00e3o just-in-time com verifica\u00e7\u00e3o de etiquetas para r\u00e1pida reetiquetagem ou necessidades adicionais de etiquetagem que possam ocorrer devido a requisitos espec\u00edficos do pa\u00eds ou do local. O modo de rebobinamento est\u00e1 dispon\u00edvel para produzir etiquetas aprovadas para aplica\u00e7\u00e3o posterior de bobina a bobina.<\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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Precis\u00e3o garantida<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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A T11 vem com duas op\u00e7\u00f5es de c\u00e2mera integradas - uma c\u00e2mera inteligente ou uma c\u00e2mera de alta resolu\u00e7\u00e3o - para proporcionar a verifica\u00e7\u00e3o ideal das informa\u00e7\u00f5es da etiqueta, dependendo do tamanho da etiqueta e da resolu\u00e7\u00e3o de impress\u00e3o. Ambas podem ser usadas para tr\u00eas tipos de verifica\u00e7\u00e3o: verifica\u00e7\u00e3o de presen\u00e7a, verifica\u00e7\u00e3o de qualidade e verifica\u00e7\u00e3o de refer\u00eancia.<\/span>\u00a0<\/span><\/p>

\u00c0 medida que as etiquetas s\u00e3o impressas, a c\u00e2mera compara cada etiqueta com um PDF da etiqueta aprovada pelo cliente para confirmar que todas as informa\u00e7\u00f5es necess\u00e1rias est\u00e3o presentes, leg\u00edveis e corretas. Se for detectado um erro, o operador \u00e9 notificado e deve confirmar que a etiqueta defeituosa foi removida antes de o sistema continuar a produ\u00e7\u00e3o.<\/span>\u00a0<\/span><\/p>

Al\u00e9m disso, o software opcional PCE Line Manager (PLM) pode exibir a origem dos defeitos para que eles possam ser mitigados. Os recursos de inspe\u00e7\u00e3o visual precisa do T11 tamb\u00e9m ajudam a garantir a precis\u00e3o quando usados com software para serializa\u00e7\u00e3o de etiquetas.\u00a0<\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tVeja o T11 em a\u00e7\u00e3o <\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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O cen\u00e1rio regulat\u00f3rio da pesquisa cl\u00ednica \u00e9 complexo. Simplifique-o com a Systech.<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Descubra como o Marca\u00e7\u00e3o e verifica\u00e7\u00e3o manual T11<\/a> combina efici\u00eancia e acessibilidade, transformando a maneira como os r\u00f3tulos s\u00e3o impressos e verificados para uso em MEs em estudos cl\u00ednicos.\u00a0<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Saiba mais<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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POST no blog<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Parte 1: O estado complexo dos r\u00f3tulos de ensaios cl\u00ednicos<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Produ\u00e7\u00e3o <\/span>Os r\u00f3tulos de ensaios cl\u00ednicos est\u00e3o repletos de desafios. O primeiro passo para super\u00e1-los \u00e9 entend\u00ea-los.\u00a0<\/span><\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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LEIA MAIS<\/a><\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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POSTAGEM NO BLOG<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Parte 2: A T11 enfrenta os desafios da produ\u00e7\u00e3o de r\u00f3tulos para ensaios cl\u00ednicos<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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O T11 Mark & Verify oferece uma solu\u00e7\u00e3o econ\u00f4mica para a impress\u00e3o e verifica\u00e7\u00e3o de etiquetas para os MEs usados em estudos cl\u00ednicos<\/span>\u00a0<\/span><\/span>\u00a0<\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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Saiba mais<\/a><\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t
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VIS\u00c3O GERAL DA SOLU\u00c7\u00c3O<\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Supere os desafios da impress\u00e3o de etiquetas para estudos cl\u00ednicos<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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De mudan\u00e7as frequentes de r\u00f3tulos a necessidades de impress\u00e3o just-in-time, a produ\u00e7\u00e3o e a verifica\u00e7\u00e3o de r\u00f3tulos para uso em estudos cl\u00ednicos podem ser complicadas.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t

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BAIXAR PDF<\/a><\/h6>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

Garanta a precis\u00e3o dos r\u00f3tulos de medicamentos experimentais para ensaios cl\u00ednicos Atenda aos rigorosos requisitos de rotulagem associados aos ensaios cl\u00ednicos de medicamentos experimentais (MEs) com precis\u00e3o e agilidade. Solu\u00e7\u00e3o flex\u00edvel e completa Imprimir e verificar r\u00f3tulos de produtos medicinais experimentais (MEs) usados em estudos cl\u00ednicos \u00e9 um desafio. Mas com a seguran\u00e7a dos participantes, a conformidade regulat\u00f3ria, as necessidades de rastreamento e [...]<\/p>","protected":false},"author":34,"featured_media":0,"parent":15017,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-25496","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nClinical Trial Labels | T11 Mark and Verify<\/title>\n<meta name=\"description\" content=\"The T11 Takes on the Challenges of Label Production for Clinical Trial Labels. 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