The IDIBELL Clinical Research and Clinical Trials Unit (UICEC), managed by the HUB’s Clinical Pharmacology service and led by the head of this service, Dr. Pilar Hereu, achieved recertification of the quality management system. Accreditation was first obtained in 2021 and requires an annual review to verify that the necessary requirements are maintained.
Through the certification entity Applus+ and according to the ISO 9001:2015 standard, the most recognized quality management, the UICEC achieved the renewal of the certification thanks to the consolidation of its quality processes. The UICEC quality management system was implemented with the support of the IDIBELL Quality Unit.
This recertification passed without any non-compliance. The recognition represents a guarantee of the quality of UICEC services and includes the processes of project management and coordination, administrative management and project processing, monitoring and pharmacovigilance of clinical assays.
The UICEC offers support to the clinical research groups of the Bellvitge Campus to carry out clinical research studies, especially clinical trials in various therapeutic areas. It provides services to researchers in the exercise of their responsibilities as independent promoters.
Functionally dependent on the Clinical Pharmacology Service of the HUB, the UICEC is part of the SCReN Platform (Spanish Clinical Research Network) of the Carlos III Research Institute (ISCIII) (PT20/00008) and of the European network ECRIN (European Clinical Research Infrastructure Network).
The ISO 9001:2015 reaccreditation of the UICEC of IDIBELL should allow maintaining quality in the provision of services, as well as improving the offer and internationalization.
UICEC activity in the last year
The UICEC maintains a sustained growth in its activity in recent years. Specifically, this 2022 has provided services to 46 active clinical trials, mostly clinical trials with medicines, 15 of which are clinical trials of the SCReN network. In recent years, the Unit has improved its internationalization and has supported 8 international clinical trials, of which 3 have funding from the H2020 call and support from ECRIN.
UICEC undertook the task of launching independent clinical trials of therapeutics in SARS-CoV-2 infection, and currently supports international clinical trials of the European consortium Vaccelerate, which evaluates therapeutic strategies with vaccines against COVID-19.
The Bellvitge Biomedical Research Institute (IDIBELL) is a biomedical research center created in 2004. It is participated by the Bellvitge University Hospital and the Viladecans Hospital of the Catalan Institute of Health, the Catalan Institute of Oncology, the University of Barcelona and the City Council of L’Hospitalet de Llobregat.
IDIBELL is a member of the Campus of International Excellence of the University of Barcelona HUBc and is part of the CERCA institution of the Generalitat de Catalunya. In 2009 it became one of the first five Spanish research centers accredited as a health research institute by the Carlos III Health Institute. In addition, it is part of the “HR Excellence in Research” program of the European Union and is a member of EATRIS and REGIC. Since 2018, IDIBELL has been an Accredited Center of the AECC Scientific Foundation (FCAECC).