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Estágio em Start-up, monitorização e gestão de estudos clínicos na Novartis Farma
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A Investigação Clínica é conduzida em seres humanos saudáveis ou doentes com o
objetivo de gerar novos conhecimentos que melhorem a prática clínica. Os Ensaios Clínicos
avaliam a eficácia e segurança das intervenções em estudo, determinando o seu riscobenefício
antes da introdução no mercado.
A partir de 31 de janeiro de 2022, os Ensaios Clínicos em Portugal passaram a ser
regidos pelo Regulamento Europeu 536/2014. Esta legislação harmoniza os procedimentos
para a condução de Ensaios Clínicos em toda a União Europeia, promovendo maior
transparência da informação e fortalecendo a competitividade no setor.
Além disso, a pandemia de COVID-19 resultou em novas abordagens para a
condução de Ensaios Clínicos, impulsionando o uso de estratégias descentralizadas. Essas
abordagens reduzem a necessidade de deslocamento dos participantes aos centros de
ensaio, utilizando visitas domiciliárias, consentimento informado eletrónico, monitorização
remota, dispositivos móveis para a recolha de dados e entrega de medicação no domicílio.
O presente relatório, desenvolvido no âmbito do Mestrado em Gestão da
Investigação Clínica, está dividido em duas secções. A primeira abrange uma revisão da
literatura das estratégias descentralizadas dos Ensaios Clínicos, com foco nas
recomendações da Agência Europeia do Medicamento para os Promotores. A segunda
secção descreve as atividades realizadas durante o estágio de Start-up, Monitorização e
Gestão de Estudos Clínicos na Novartis. Esta experiência proporcionou um primeiro
contacto com o mercado de trabalho e permitiu desenvolver competências profissionais e
pessoais relevantes para a gestão da Investigação Clínica.
Clinical Research is conducted on healthy or sick volunteers with the aim of generating new knowledge to improve clinical practice. Clinical Trials evaluate the efficacy and safety of study interventions, determining their risk-benefit ratio before market introduction. As of January 31, 2022, Clinical Trials in Portugal are governed by the European Regulation 536/2014. This legislation harmonizes procedures for conducting Clinical Trials across the European Union, promoting greater transparency, and strengthening competitiveness in the sector. Furthermore, the COVID-19 pandemic has led to new approaches in conducting Clinical Trials, driving the adoption of decentralized strategies. These approaches reduce the need for participants to visit trial sites, utilizing home visits, electronic informed consent, remote monitoring, mobile devices for data collection, and home delivery of medication. This report, developed as part of the Master’s Degree in Clinical Research Management, is divided into two sections. The first covers a literature review on decentralized clinical trial strategies, focusing on the recommendations of the European Medicines Agency for Sponsors. The second section describes the activities undertaken during the internship in Start-up, Monitoring, and Clinical Study Management at Novartis. This experience provided an initial contact with the job market and helped develop key professional and personal skills relevant to Clinical Research management.
Clinical Research is conducted on healthy or sick volunteers with the aim of generating new knowledge to improve clinical practice. Clinical Trials evaluate the efficacy and safety of study interventions, determining their risk-benefit ratio before market introduction. As of January 31, 2022, Clinical Trials in Portugal are governed by the European Regulation 536/2014. This legislation harmonizes procedures for conducting Clinical Trials across the European Union, promoting greater transparency, and strengthening competitiveness in the sector. Furthermore, the COVID-19 pandemic has led to new approaches in conducting Clinical Trials, driving the adoption of decentralized strategies. These approaches reduce the need for participants to visit trial sites, utilizing home visits, electronic informed consent, remote monitoring, mobile devices for data collection, and home delivery of medication. This report, developed as part of the Master’s Degree in Clinical Research Management, is divided into two sections. The first covers a literature review on decentralized clinical trial strategies, focusing on the recommendations of the European Medicines Agency for Sponsors. The second section describes the activities undertaken during the internship in Start-up, Monitoring, and Clinical Study Management at Novartis. This experience provided an initial contact with the job market and helped develop key professional and personal skills relevant to Clinical Research management.
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Clinical Research Clinical Trials Start-up Monitoring Management Legislation Sponsor Decentralization