CERCA GINYS

Ana Aldea Perona

Responsable CRU

aaldea@imim.es | ORCID | PRC page

La USIC està situada a la planta 13 de l'Àrea Maternoinfantil (AMI) de l'HUVH i posa a disposició de la investigació clínica els següents serveis i espais: 7 consultoris totalment equipats pel seguiment i exploració dels pacients inclosos en estudis clínics, sala per a extraccions o infusió de medicació, un laboratori pel tractament i conservació de mostres clíniques, un arxiu per a la documentació de l’estudi, i espais per a reunions, monitoritzacions i/o auditories; així mateix dona suport d’infermeria de recerca per a les extracció, processament i gestió de mostres biològiques, i altres proves complementàries.

Staff

Ana Aldea Perona | aaldea@imim.es | ORCID | PRC Page

IMIM - Institut Hospital del Mar d'Investigacions Mèdiques

Parc de Recerca Biomèdica de Barcelona (PRBB)
Dr. Aiguader, 88, 1r pis, despatx 153

08003 Barcelona http://www.imim.es/

Food system
Education and knowledge generation system
Industrial system
Socio-sanitary system

ISO 9001 sets out the criteria for a quality management system. This standard is based on a number of quality management principles that include a strong customer focus, motivation and involvement of senior management, process focus, and continuous improvement. The use of the ISO 9001 standard helps to ensure that customers receive consistent and good quality products and services, which in turn brings many business benefits.

Phase I clinical trials are the first stage in the cynical development of a new drug and do not have as their main objective to evaluate the efficacy of the drug in research, but other parameters such as the pharmacokinetic profile in humans, tolerance or possible interactions. with other medicines, food, etc. Traditionally, these trials are done with healthy volunteers.

Certificate of Good Clinical Practice - AEMPS Good Clinical Practice (GCP) is a term coined in the United States that encompasses a set of rules aimed at guaranteeing the rights of subjects participating in a clinical trial, ensuring the quality of data, and avoiding errors in clinical research.

Standard operating procedure (SOP or PNTs) Manufacture of sanitary product to measure regulated by the Regulation (EU) 2017/745 of sanitary product

REGIC is the first association of clinical research management organizations created in Spain at the request of professionals, to share experiences and create a space for interaction and training in the management of healthcare R & D & I.

SCReN: Support for multicenter clinical trials Achieve an advanced level of technical competence in the processes related to the development and management of clinical research, ensure compliance with legal requirements and the competence of researchers participating in platform studies on methodological aspects and PCBs. others.

The BCTP has as its great challenge to advance the arrival of innovative treatments to patients in Catalonia. BCTP needs to improve the coordination, integration, quality, inclusiveness and speed of clinical research. This will be thanks to the optimization and homogenization of the clinical research processes of its members, as well as the human and technological potential of the centers. In addition, the BCTP will function as a dissemination platform to attract new studies from outside Catalonia.

Clinical research unit

Staff

INSTITUTE

DOMAINS RIS3CAT

CATEGORIES

RATES AND ACCESS

QUALITY CONTROL

FACILITIES NETWORKS