Unidad de Investigación Clínica Independiente y Ensayos Clínicos

Independent Clinical Research and Clinical Trials Unit of IBIMA Plataforma BIONAND (UICEC-IBIMA Plataforma BIONAND)

IBIMA Clinical Research and Clinical Trials Unit (UICEC-IBIMA) is a multidisciplinary research structure of the Biomedical Research Institute of Málaga, the Regional University Hospital of Málaga, the Virgen de la Victoria University Hospital, and Primary Care for conducting clinical research studies.

UICEC IBIMA forms part of the Clinical Research Units and Clinical Trials Platform SCReN (Spanish Clinical Research Network) and is partially funded by the Carlos III Health Institute (PT23/00137; PT20/00127). On the European level, SCReN forms part of the ECRIN, the European Clinical Research Infrastructure Network, and is the national hub for Spain. It provides support and management for international multicenter clinical trials.

Services

Scientific, methodological, and regulatory advice.
Management and administrative processing.
Coordination and scientific management of clinical research.
Scientific management of clinical research.
Study development: Pre-Initiation of Clinical Trial, Development, Completion, and Closure.
Monitoring.
Pharmacovigilance.

01. What projects can be submitted?

Clinical trials with drugs, medical devices, or surgical techniques. Post-authorization studies.
Various interventions with medicines or medicinal products using alternative designs to the clinical trial and in any phase of their development.

02. UICEC IBIMA Priorities

Clinical trials (with both medicines and medicinal products).
Independent sponsor.
Multicenter projects (as part of a network).

Does the project meet all the requirements of the definition of 'Independent or Non-commercial Clinical Research'? Requirements for Independent Clinical Research:

• A sponsor can be a university, hospital, public scientific organization, non-profit organization, patient association, or individual investigator.
• The research data are the sponsor’s property from the start of the study.
• There are no agreements between the sponsor and third parties that allow for the use of data for regulatory uses or for uses that generate industrial property.
• The design, conduct, recruitment, data collection, and communication of research results are under the control of the sponsor.
• Given their characteristics, these studies cannot form part of a development program for the marketing authorization of product.

04. Who can submit research projects?

Any researcher from the Regional University Hospitals or Virgen de la Victoria Hospital in Malaga, Primary Care, or translational groups from the University of Malaga (UMA) can request assistance related to the design, implementation, and conduct of independent clinical trials in accordance with the wide range of services offered by UICEC-IBIMA. These services include methodological support, CRD preparation, contract management, procedures with competent authorities, pharmacovigilance, pre-initiation, initiation visits, periodic monitoring visits, and clinical trial closure.

05. When can the project be submitted?

If the project is going to be submitted to a public funding call, the application must be submitted at least three weeks before the deadline of the call. In the Expression of Interest form of IBIMA for competitive public calls, it should be indicated whether the research project is a Clinical Trial or an Observational Study.
If the project is not subject to a specific call, the application can be submitted at any time.