Banca de QUALIFICAÇÃO: NINA CAMILA CAMPOS DE ALMEIDA

Uma banca de QUALIFICAÇÃO de MESTRADO foi cadastrada pelo programa.
STUDENT : NINA CAMILA CAMPOS DE ALMEIDA
DATE: 09/10/2023
TIME: 09:30
LOCAL: Remoto
TITLE:

Clinical research center; Clinical trial; Quality; Framework; Lean Healthcare; Value stream mapping

KEY WORDS:

Clinical research center; Clinical trial; Quality; Framework; Lean Healthcare; Value stream mapping

PAGES: 112
BIG AREA: Engenharias
AREA: Engenharia de Produção
SUMMARY:

Clinical research invests large resources throughout its testing and approval phases. A very expensive step for pharmaceutical companies is the recruitment and selection of research individuals, which takes place through clinical trial centers. These, based on the protocols, are responsible for ensuring that recruitment and selection procedures, care, exams, monitoring and others, are carried out efficiently and effectively, both in the use of resources made available by the sponsor, and in the generation of data. real, quality and within the deadlines determined by this stakeholder. Among the activities carried out by research centers in clinical trials, recruitment is considered one of the most relevant parts, since without volunteers there is no study. Having quantity combined with quality is a crucial factor, as well as reaching the goal agreed with the sponsor in a timely manner, ensuring that the study does not become dispersed and take much longer than planned for its development, resulting in increasingly higher costs. In this context, adapting the center's operations to the requirements of the specific protocol is essential for the adequate progress of activities. The general objective is to propose a framework based on Lean Healthcare for the adequate preparation of research centers, aiming to guarantee recruitment and conduct of clinical trials with efficiency and quality. In this sense, the study deals with the results of a research center, which promoted the remodeling of clinical trials, based on a systematized sequence of steps to be followed before starting the protocol. To define these steps, the Lean Healthcare methodology was used as a basis, from its concept to its tools, in the search for added value from the patient's perspective, acting through the identification, development and analysis of their value streams, with aimed at quality, productivity and effectiveness in meeting the proposed goals. To validate the new established process, an action research was carried out, which resulted in the real scope of recruitment carried out in record time by the research center, in the participation of a study for a vaccine against COVID-19 together with other centers spread around the world. around the world, with this company being responsible for including (randomizing) 3100 volunteers during 18 days of recruitment, with an average service lead time of 3 hours in visit 1 of the trial. Finally, a process framework is proposed, containing the main steps identified as key to achieving the expected results.

COMMITTEE MEMBERS:
Externo à Instituição - SUE ANN COSTA CLEMENS
Interno - 1229030 - HELIO ROBERTO HEKIS
Interna - 1777131 - MARIANA RODRIGUES DE ALMEIDA