Medicines Study Unit (UEM)
The Medicines Study Unit (UEM) undertakes the design, coordination and monitoring of research with medicines. The UEM interacts with other sectors and researchers of the IDIAP.
The UEM is amember of SCReN (Spanish Clinical Research Network ), a platform that supports clinical research, in particular multicentre clinical trials, constituted by 29 research units (UICEC – Unidad de Investigación Clínica y Ensayos Clínicos) in 11 autonomous communities.
The main responsabilities of the UEM are:
- Independent clinical trials: legal, administrative, methodological, statistical and data management support, pharmacovigilance, monitoring and management of medicines.
- Support in the global management of non-independent clinical trials.
- CEI: new circuits in accordance with the RD 1090/2015, supervision, technical and administrative office, evaluation.
- Observational studies (pharmacoepidemiology and pharmacovigilance, PASS studies required by the risk management plans of the EMA) with the SIDIAP: SIDIAP scientific committee, technical, methodological, statistical and scientific support.
- Development of other research projects with medicines.
- Rosa Morros Pedrós, coordinator
- Pau Moreno Nogué, project manager technician
- Helena Pera Pujadas, monitor and trial coordinator
- Ana García Sangenís, monitor and trial coordinator
- Maria Giner Soriano, scientific and methodologic support
- Dan Ouchi Vernet, statiscian
- Oriol Prat Vallverdú, biostatiscian
- Ainhoa Gómez Lumbreras, pharmacovigilance