Clinical trials
Introduction
The Biomedical Research Institute of Lleida (IRBLleida) brings together all biomedical research carried out in the province of Lleida by two key institutions: the Department of Health and the University of Lleida (UdL). The former includes research professionals from its two healthcare providers: the Catalan Health Institute (ICS; Arnau de Vilanova University Hospital of Lleida (HUAV), Primary and Community Care of Lleida and the Alt Pirineu i Aran regions) and Health Services Management (GSS; Santa Maria University Hospital (HUSM) and the Pallars Regional and Mental Health Hospital, among others).
The Clinical Trials Unit of IRBLleida aims to support researchers, laboratories, and companies that need to evaluate the efficacy and safety of new treatments, products, or healthcare interventions.
Our mission is to establish ourselves as a leading clinical research unit by promoting and facilitating high-quality, rigorous, and innovative research. We work to strengthen our own research activity while also attracting studies sponsored by both public and private entities, creating an environment that fosters the development of high-impact clinical projects.
Since 2023, the Clinical Trials Unit has been part of the Clinical Research Support Platform of the Carlos III Health Institute (ISCIII), enabling it to become a member unit of the SCReN Platform (Spanish Clinical Research Network), coordinated and promoted by ISCIII.
Since November 2024, the Clinical Trials Unit has been certified according to the ISO 9001:2015 standard, demonstrating its commitment to excellence, integrity, and scientific rigor, and positioning it as a benchmark in the management and development of high-quality clinical trials.
Organizational Structure
Clinical Studies Management Unit
Responsible for managing study documentation, clinical study contracts, and budget negotiations, this unit works to streamline and facilitate the development of projects within our institution, ensuring high-quality outcomes in the shortest possible timeframe.
In addition, it coordinates collaboration between investigators and the various internal and external stakeholders involved in each study, while providing support and guidance on methodological, ethical, and regulatory matters.
Clinical Research Support Unit
Responsible for the comprehensive management of clinical trials, this unit provides support in methodological design, monitoring, data collection and management, as well as direct assistance to investigators throughout the different stages of a clinical study.
Its team ensures the efficient and rigorous execution of studies, continuously overseeing compliance with ethical requirements, current regulations, and Good Clinical Practice (GCP) guidelines.
Clinical Trials Pharmacy Unit
This unit aims to ensure the proper management of investigational medicinal products, from storage and preparation to administration under optimal safety conditions. It works closely with the rest of the clinical team to ensure that investigational products are handled and administered in accordance with the highest standards.
Research Ethics Committee with Medicinal Products (CERm)
Ethics committees play a key role in the conduct of clinical trials and other research studies. The ethical, methodological, and legal evaluation of clinical trials and research projects must be carried out by a Research Ethics Committee with Medicinal Products (REC/RECm).
IRBLleida is affiliated with the CERm of the Arnau de Vilanova University Hospital, under the Territorial Management of Lleida and Health Services Management (GSS), in accordance with current legislation.
