Investigación Clínica - Asistencial

Clinical Research Facilities

The Clinical Research Facilities are infrastructures dedicated exclusively to clinical research and provide the researchers with the necessary resources, both material and human, for the proper conduction of clinical trials and other research projects. The infrastructures include examination rooms, Day Hospital, laboratories, equipment, and skilled nursing staff.

Since the beginning of its activity in 2014, in this area, more than 3,000 patients have been treated in 200 clinical trials of different phases (from early phases to phase III). Several medical services conduct their clinical studies in this area: Medical Oncology, Internal Medicine, Dermatology, Nephrology, Infectious Diseases, Rheumatology, Urology, Digestive System, Endocrinology, Allergology, and Pediatrics.

Facilities and equipment

Located in the University Hospital Reina Sofia, the areas dedicated to clinical studies cover approximately 2.000 square meters and are distributed in two fully adapted and renovated areas:

IMIBIC Clinical Research Building
Provincial Hospital, first floor left wing

Each of them has all the necessary infrastructure for conducting clinical studies:

9 Examination rooms, equipped for the monitoring and exploration of patients
2 Day Hospitals for adults, with 14 articulated armchairs and 3 beds, equipped with nursing control, instrumental monitoring equipment, advanced resuscitation systems, support medication, and audiovisual systems
Reception and waiting room for participants and relatives
Living room for patients
Laboratories for processing of biological samples, equipped with centrifuges with temperature control
Refrigerators, freezers and ultra freezers with monitored alarm system and centralized temperature controll
Warehouses for material and consumables
Document archive with fire protection means
Data management and monitoring premises equipped with computers, fax and telephones
Basic equipment such as electrocardiographs, blood pressure monitors, scales with stadiometer, and pulse oximeters

The Unit is equipped with a Logiq E9 ultrasound system that combines real-time ultrasound with ultrasound images or other modalities, such as tomography or resonance.

The multipurpose room is a large and versatile space with capacity for giving presentations, investigator meetings, group activities, etc. One part of the room can be used as a gym, with the necessary equipment to collect physical activity parameters.

The area dedicated to Paediatric clinical research is located on the ground floor of the IMIBIC Clinical Research Building. It has independent access and reception desk, toilets, a medical examination room and a fully equipped Day Hospital adapted to this population.

Researchers interested in using these resources should follow the corresponding procedures and provide the necessary documentation described in the "Documento sobre uso del Área asistencial y el Formulario de Solicitud de Servicios", only available in Spanish.

Nursing Team

The Clinical Research Unit’s nursing team is a group of specialised professionals whose main objectives are to provide safe and high quality nursing care to participants of clinical studies and ensure the correct implementation of the study protocols. To do this, they collaborate directly with the multidisciplinary research teams (investigators, study coordinators, data managers) who conduct their studies within the Clinical Study Facilities.

The nursing staff is accredited in Standards of Good Clinical Practice and Advanced Life Support. They have experience in a wide variety of clinical research protocols, especially in oncological clinical trials and administration of cytostatic treatments.

Activities:

Administration of research medication according to study protocols
Blood extractions and sample management
Electrocardiograms (ECG)
Anthropometric parameters recording (weight, height) and measurement of vital signs (blood pressure, temperature, heart rate)
Observation of participants during their admission to the Clinical Study Facilities and treatment of symptoms
Initial assessment and nursing care
Follow-up of patients
Data collection

Team members

Nurses

Assistant nurses

Inmaculada Gálvez Membrives
Elena Parrado González
Rubén Sánchez Nieves

Pharmacy Team

The clinical trials area of the Pharmacy Service provides support for investigators and guarantees adequate control, management, storage and preservation of investigational drugs, and access to information on the study drugs.