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A MedAssessment, Inc. é uma CRO líder em farmacovigilância dos EUA que fornece soluções de segurança de medicamentos abrangentes e confiáveis para empresas farmacêuticas em todo o mundo. Com uma equipe dinâmica de M.D.s multilíngues, MD-PhD, RNs e escritores médicos certificados, a MedAssessment oferece experiência inigualável no campo da farmacovigilância.
Na MedAssessment, o foco é garantir a segurança do paciente por meio da identificação e gerenciamento de eventos adversos associados a medicamentos. Os serviços da empresa incluem processamento de casos, detecção e gerenciamento de sinais, planejamento e implementação de gerenciamento de riscos, relatórios agregados (PSUR/PBRER), monitoramento e avaliação de literatura, bem como suporte à conformidade regulatória.
Um dos principais pontos fortes da MedAssessment é sua equipe de profissionais altamente qualificados e com ampla experiência em farmacovigilância. Os escritores médicos da empresa são especialistas em redigir relatórios de estudos clínicos (CSRs), protocolos de ensaios clínicos (CTPs), Folhetos do investigador (IBs), bem como outros documentos regulamentares necessários para o desenvolvimento de medicamentos.
A MedAssessment também possui experiência no uso do ORACLE ARGUS® GLOBAL DATA BASE, que é um software amplamente utilizado para gerenciamento de dados de eventos adversos. Este software permite o processamento eficiente de casos, garantindo a conformidade com os regulamentos globais, como ICH E2B(R3).
O compromisso da empresa com a qualidade se reflete em sua certificação ISO 9001:2015, que garante que todos os processos sejam padronizados e monitorados continuamente para melhoria. Além disso, MedAssessment adere a todas as diretrizes relevantes, como ICH E2A/E6/E8/E9/E11/GCP/ICH Q3C/Q3D/Q4B/Q7/Q8/Q9/Q10.
A MedAssessment se estabeleceu como um parceiro confiável para empresas farmacêuticas que buscam terceirizar suas atividades de farmacovigilância. A capacidade da empresa de fornecer soluções personalizadas para atender às necessidades específicas do cliente lhe rendeu uma excelente reputação no setor.
Em conclusão, se você está procurando um parceiro confiável para suas necessidades de farmacovigilância, não procure mais, MedAssessment Inc. Com sua equipe experiente de profissionais que possuem amplo conhecimento sobre regulamentos de segurança de medicamentos, juntamente com tecnologia de ponta como ORACLE ARGUS® GLOBAL DATA BASE; você pode ter certeza de que a segurança de seus pacientes sempre terá prioridade máxima em todas as etapas do processo de desenvolvimento de medicamentos, desde os ensaios pré-clínicos até a vigilância pós-comercialização!
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