Biostatistics procedures in a CRO

• Autor(a) principal: Freire, Francisca Monteiro
• Data de Publicação: 2021
• Tipo de documento: Dissertação
• Idioma: eng
• Título da fonte: Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)
• Texto Completo: http://hdl.handle.net/10773/33819
• topic: CRO; Clinical research; Biostatistics; Medical statistics; Clinical studies; SAS programming

This report details the tasks and activities completed during the curricular internship carried out at CTI, Clinical Trial and Consulting Services Portugal, to obtain a master's degree in Medical Statistics at the University of Aveiro. During this time, different tasks and activities were performed in the area of biostatistics, putting into practice many of the concepts acquired especially during the masters. The main objective of this internship was to explore the concepts, requirements, and practices inherent in biostatistics from a CRO point of view. For this purpose, firstly, there was a more theoretical component that included two main tasks: the general regulatory training conducted, consisting in internal procedures and the regulatory background for clinical research; and a set of presentations prepared on topics related to biostatistics in the context of clinical research and presented to the biostatistics team. Subsequently, there was a more practical component that consisted in the participation in various clinical studies, observational and experimental, mostly involving statistical programming in SAS® and statistical writing. For this last task, some statistical methodologies were applied, such as: parametric and non-parametric statistical tests, statistical models with special emphasis on regression and survival analysis models, among others.