| Name: | Description: | Size: | Format: | |
|---|---|---|---|---|
| 1.6 MB | Adobe PDF |
Authors
Abstract(s)
O presente relatório resulta do estágio curricular realizado no âmbito do Mestrado em
Biotecnologia na Universidade da Beira Interior. O estágio decorreu na BlueClinical -Investigação
e Desenvolvimento em Saúde, Lda durante aproximadamente sete meses e teve como foco a
realização de ensaios clínicos de fase I. A BlueClinical é umas das principais empresas em Portugal
que realiza ensaios clínicos de diversas fases, sendo especializada em ensaios de fase I, onde
incidiu o meu estágio. A BlueClinical garante qualidade e clareza na realização de todos os ensaios
clínicos, assim como dos estágios que acolhe. Esta elevada qualidade advém da sua preocupação
e necessidade de cumprir todos os requisitos legais em vigor, e o foco no treino de todos os
colaboradores antes de iniciar as suas funções.
Para a realização do estágio, e consequentemente, para a elaboração deste relatório foi definido
como objetivo geral a compreensão e participação na realização de ensaios clínicos de fase I na
unidade clínica da BlueClinical. Para cumprir este objetivo, fui responsável pela produção dos
documentos necessários para a parte laboratorial, realização de turnos clínicos atribuídos durante
o ensaio, preenchimento dos documentos segundo protocolo e envio das amostras para análise.
Estruturalmente, este relatório de estágio encontra-se dividido em seis partes, sendo a primeira
destinada à apresentação da empresa e apresentação dos serviços prestados. Na segunda parte é
realizado um breve enquadramento teórico, onde são exploradas as investigações dos novos
medicamentos, que tipo de estudos existem, os diferentes tipos de ensaios clínicos, a legislação
portuguesa e europeia, e um pequeno contexto numérico sobre ensaios clínicos realizados em
Portugal. Na terceira parte encontram-se apresentados os objetivos específicos para a realização
do estágio. A quarta parte corresponde à explicação de como na BlueClinical os ensaios clínicos
de fase I ocorrem numa forma mais detalhada sem nunca colocar em causa a integridade e
confidencialidade. A quinta parte é uma explicação de tudo o que era minha responsabilidade,
como técnica de laboratório, realizar antes, durante e após a finalização de um ensaio clínico. Por
fim, temos uma conclusão de como correu o estágio e se todos os objetivos foram cumpridos.
This report is the result of the curricular internship carried out within the scope of the Master's in Biotechnology at the University of Beira Interior. The internship took place at BlueClinical - Investigação e Desenvolvimento em Saúde, LDA for approximately seven months and focused on carrying of phase I clinical trials. BlueClinical is one of the main companies in Portugal that carries out clinical trials of different phases, being specialized in phase I trials, which is where my internship took place. BlueClinical guarantees quality and clarity when carrying out all clinical trials, as well as internships. This high quality comes from its concern and need to comply with all legal requirements in force, and the focus on training all employees before starting their duties. To carry out the internship, and consequently, to prepare this report, the general objective was defined as understanding and participating in the conduct of phase I clinical trials at the BlueClinical clinical unit. To achieve this objective, I was responsible for producing the necessary documents for the laboratory part, carrying out clinical shifts assigned during the trial, completing the documents according to the protocol and sending the samples for analysis. Structurally, this internship report is divided into six parts, the first being intended to present the company and the services provided. In the second part, a brief theoretical framework is provided, where research into new medicines is explored, what types of studies exist, the different types of clinical trials, Portuguese and European legislation, and a small numerical context on clinical trials carried out in Portugal. The third part presents the specific objectives for carrying out the internship. The fourth part corresponds to the explanation of how at BlueClinical phase I clinical trials occur in a more detailed way without ever compromising integrity and confidentiality. The fifth part is an explanation of everything that it was my responsibility, as a laboratory technician, to carry out before, during and after the completion of a clinical trial. Finally, we have a conclusion on how the internship went and whether all objectives were met.
This report is the result of the curricular internship carried out within the scope of the Master's in Biotechnology at the University of Beira Interior. The internship took place at BlueClinical - Investigação e Desenvolvimento em Saúde, LDA for approximately seven months and focused on carrying of phase I clinical trials. BlueClinical is one of the main companies in Portugal that carries out clinical trials of different phases, being specialized in phase I trials, which is where my internship took place. BlueClinical guarantees quality and clarity when carrying out all clinical trials, as well as internships. This high quality comes from its concern and need to comply with all legal requirements in force, and the focus on training all employees before starting their duties. To carry out the internship, and consequently, to prepare this report, the general objective was defined as understanding and participating in the conduct of phase I clinical trials at the BlueClinical clinical unit. To achieve this objective, I was responsible for producing the necessary documents for the laboratory part, carrying out clinical shifts assigned during the trial, completing the documents according to the protocol and sending the samples for analysis. Structurally, this internship report is divided into six parts, the first being intended to present the company and the services provided. In the second part, a brief theoretical framework is provided, where research into new medicines is explored, what types of studies exist, the different types of clinical trials, Portuguese and European legislation, and a small numerical context on clinical trials carried out in Portugal. The third part presents the specific objectives for carrying out the internship. The fourth part corresponds to the explanation of how at BlueClinical phase I clinical trials occur in a more detailed way without ever compromising integrity and confidentiality. The fifth part is an explanation of everything that it was my responsibility, as a laboratory technician, to carry out before, during and after the completion of a clinical trial. Finally, we have a conclusion on how the internship went and whether all objectives were met.
Description
Keywords
Blueclinical Ensaios Clínicos Fase I Laboratório