Clinical Research and Clinical Trials

Clinical Trials (CT) are the prototype of the experimental model in humans. They require design, procedures and oversight, and specific surveillance. These reasons are sufficient for identifying a specific platform encompassing them.

The Clinical Trials ECAI aims to situate the IBIMA at a high level of excellence for the development and implementation of clinical trials and observational studies, providing both administrative and technical support, promoting and supporting the management and development of CT, both commercial and independent.

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.

  • Objectives
  • Services
  • Members
  • Contribute to improving the positioning of IBIMA at an national and international level in the field of clinical research.
  • Increase the number of commercial and independent CT, providing both technical and administrative support as well as institutional representation.
  • Promote the development of phase I CT.
  • Align and ensure the development of CT to strengthen the strategic lines of IBIMA and its area of influence.
  • Translate the research policies of the SSPA and health care priorities from hospitals to the clinical research model.
  • Ensure the highest excellence, effectiveness and efficiency in clinical research programs generated.
  • Collaborate with other stakeholders (biotechnology or pharmaceutical industry) in research, development and implementation of scientifically relevant CT, especially those of a multicenter, multinational character.
  • 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.
  • Antonio Eloy Guzmán Guzmán
  • Antonio Pérez Rielo
  • Aránzazu Linares Alarcón
  • Gloria Luque Fernandez
  • Maria Isabel Lucena González
  • Mercedes Robles Díaz
  • Natalia Andere
  • Ricardo Aragoncillo Ortiz
  • Trinidad Casquero Huertas
  • Virginia Vázquez Rodríguez
Clinical Research and Clinical Trials