Clinical Research and Clinical Trials
The Clinical Trials ECAI functions as an open unit, not only for researchers at University Hospitals that are part of IBIMA, but also for the promoters of the Pharmaceutical Industry, other healthcare facilities, scientific societies and Contract Research Organizations (CRO).
The Regional University Hospital in Malaga has had a Unidad Central de Investigación Clínica en Ensayos Clínicos (Central Clinical Research Unit in Clinical Trials – UCICEC) of the Consortium for the of Support of Biomedical Research Network (CAIBER) since its establishment in 2009, which also offers, advice and methodological and scientific support to the Virgen de la Victoria University Hospital in Malaga.
Due to this functional convergence it now functions as a study ECAI.
- Advice on independent CT for researchers.
- Consulting on commercial CT, both for researchers and businesses.
- Processing of local documents, for both single-center and multicenter CT, required by the various authorities: Spanish Agency for Medicines and Health Products, local and regional Research Ethics Committees.
- Advice on legal and ethical issues.
- Specialized administrative support.
- Consulting and management of the implementation the study, opening of the center.
- Management of case report forms (CRF) and overall project management.
- Contract management and financial reports.
- Management of documentation.
- Monitoring of studies.
- Follow-up in pharmacovigilance. Annual reports.