Start-up e monitorização de estudos clínicos

• Autor(a) principal: Silvério, Catarina de Oliveira Belmonte
• Data de Publicação: 2022
• Tipo de documento: Dissertação
• Idioma: por
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10362/147983
• topic: clinical research; clinical trial unit; start-up; masters; management; monitoring; Domínio/Área Científica::Ciências Médicas

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.