This month, the IDIBELL Clinical Research Unit in Clinical Trials (UICEC), led by Dr. Pilar Hereu, head of the Clinical Pharmacology Service of the Bellvitge University Hospital (HUB), has managed to certify through Applus and according to the standard ISO 9001:2015 its quality management system, which has been implemented with the support of the Quality Unit of IDIBELL.
This recognition is a seal of the quality of the services of the UICEC, which works to offer support to the clinical research groups of the Bellvitge Campus to carry out clinical research studies, especially clinical trials. The UICEC provides services to researchers in the exercise of their responsibilities as independent promoters: project management and coordination, administrative management and processing of the project, monitoring and pharmacovigilance.
The UICEC, functionally dependent on the HUB’s Clinical Pharmacology Service, is part of the SCReN Platform, the Carlos III Research Institute Support Platform (ISCIII) (PT20/00008) and the European Ecrins network (European Clinical Research Infrastructure Network).
The activity of the UICEC has had a sustained growth in the period 2017-2020, going from 26 active projects in 2017 to 45 in the last year. The distribution of the 2020 studies has been: 37 studies in the HUB, 3 in the ICO, 2 in the IDIBELL and 3 AC, in which it acts as a pharmacovigilance node of the SCReN Platform. During 2020, the UICEC has also supported the launch of 6 clinical trials that evaluate treatment strategies for SARS-Cov-2 infection.
Additionally, as a Unit integrated in the European Ecrins network, it currently provides services to 3 independent international multicenter clinical trials that have funding from the H2020 call and support from this network.
The ISO 9001:2015 accreditation of the IDIBELL UICEC was an objective of the unit within the framework of the SCReN Platform (PT17 / 0017/0010), which has been achieved and should allow maintaining quality in its provision of services and improve its offer and internationalization.