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Start-up e monitorização de estudos clínicos
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Orientador(es)
Resumo(s)
Clinical Investigation consists in a type of integrative research of several areas
within the life sciences field. It allows to adopt new medical procedures and to put new
pharmaceuticals and medical devices on the market. During the last few years, Precision
Medicine has been evolving rapidly, making an impact on the observational and clinical trials
dynamics. However, there are some identified economical constraints that should not be
dismissed. In order to increase the success rate of clinical studies, and the effectiveness of
resource usage, it is vital to establish collaborations with specialized structures.
Clinical Trial Units are multidisciplinary units that dedicate themselves to the design,
conduction and publication of clinical studies results. Taking into account the growing
complexity associated to performing clinical studies, the scientific, methodologic and
logistical support provided, these units are a key factor to the success of clinical studies.
The entry into force of the new European medical device regulation (2017/745) represents
an example of the support given by these units. The dynamics of medical device
commercialization has been significantly altered both at a European and national levels.
Clinical Trial Units present themselves as structures with the necessary resources to aid
manufacturers and/or sponsors transitioning to the new regulatory framework.
On the scope of the Masters Degree on Clinical Research Management, an
internship was performed on the start-up and monitoring fields at NOVA Clinical Research
Unit. This opportunity allowed to acquire and consolidate soft and hard skills and,
simultaneously, to experience the reality of the job market on the field of clinical research
management.
Descrição
Palavras-chave
clinical research clinical trial unit start-up masters management monitoring