Presentation


Research on health problems constitutes a key instrument to improve the quality and life expectations of citizens, as well as to increase the general and economic well-being of society.

These advances in fundamental knowledge will only translate into quality of life and well-being for people when they can be applied to improve the prevention, diagnosis and treatment of diseases.

Before anyone can take a drug, preclinical trials are performed to obtain initial evidence of safety and pharmacological activity. This may include laboratory tests or animal studies.

However, research on human subjects is irreplaceable when seeking to obtain evidence on the safety and clinical efficacy of new drugs to treat a defined pathology.

Clinical trials are clinical research that is carried out prior to the marketing of a new medicine. This research must be carried out with the maximum guarantees of safety for the individuals who participate in it. It is controlled according to strict scientific, ethical and legal principles.

The IIS Aragón Clinical Research Unit provides support for the implementation of clinical trials and observational post-authorization studies carried out at the Miguel Servet University Hospital Hospital Complex, Lozano Blesa University Clinical Hospital and in Primary Care.

General objectives


Increase the volume of Clinical Trial activity and its quality, in accordance with the R&D&I plan.

Increase your scientific performance.

Increase research into trials without commercial interest.

Promote translational research by coordinating basic and clinical research groups so that it has an impact on innovation and quality of healthcare.

Featured Features


Support for the development of the clinical trial

Documentation, database management and administrative management

Support for research personnel

Organizational structure


The Clinical Research Unit has the following structure:
IIS Aragon Coordination
   UIC Miguel Servet University Hospital
   UIC Lozano Blesa University Clinical Hospital
   Primary Care UIC

Clinical research unit – Miguel Servet University Hospital

Infrastructure:
Clinical interview room (14,4 m2)
Extraction and functional testing room (15,7 m2)
Waiting room (13,2 m2)
Work office (31,9 m2)
Laboratory (17,4 m2)
Warehouse (19,5 m2)
Human Resources:
A clinical trials nurse
A laboratory technician.

Clinical research unit – Lozano Blesa University Hospital

It is located on the first floor of the General Hospital. It is fully operational, offering support to the hospital's clinical research groups.

Infrastructure:
Administrative room (16,24 m2)
Clinical interview, extraction and laboratory room (14,87 m2)
Human Resources:
A clinical trials nurse.
 

Clinical research unit – Primary care

The Research Unit – Primary Care is a space located in the Arrabal Health Center, entirely dedicated to the promotion of research in Primary Care, with clinical trials being one of its main pillars. Among its functions, the development of research projects, clinical trials and observational studies in the field of Primary Health Care stands out.

 

Staff


 

Coordinator of the Clinical Research Unit
Eva Lopez Hernandez
Telephone: 976 71 65 82
Email: emlopezh@iisaragon.es

Contract management

Raquel Rueda Hernandez
Telephone: 976 71 36 32
Email: rrueda@iisaragon.es

Sarai Cloquell Abajo
Telephone: 976 71 69 86
Email: scloquell@iisaragon.es

Carmen Biota Blas
Telephone: 976 71 58 94
Email: cbiota@iisaragon.es

Economic management
Monica Ramos Cardenal
Telephone: 976 71 68 38
Email: mramos@iisaragon.es

Clinical Trials Monitor
Pablo Serrano Irigoyen
Email: pserrano@iisaragon.es

Clinical studies


 

The Clinical Research Management Unit processes the implementation of clinical studies.

2Observational studies with medication (EOM)
Observational studies with medication (Contract proposal) Spanish

Documentation to present for the processing of the contract:

   Favorable opinion from the CIEm
   Complete study protocol
   Patient Information Sheet and Informed Consent: if applicable
   Economic report of the study
   Commitment of the Principal Investigator who is going to participate in one of the centers of our Autonomous Community
   Authorization of the Autonomous Community: in the case of observational studies with prospective follow-up medication promoted by the Pharmaceutical Industry
3Non-EPAs/PI
Non-EPA Contract Model Spanish English

Activity


Participation of Hospitals of Aragon in clinical trials

The main thematic areas in which clinical trials are being carried out at the Miguel Servet University Hospital and Lozano Blesa University Clinical Hospital are: oncology, digestive, ophthalmology, hematology, neurology, internal medicine and cardiology, among others. The number of active clinical trials in these hospitals is 316

Platform for Clinical Research Units and Clinical Trials (SCREN)


The Aragón Health Research Institute is integrated into the Platform of Clinical Research Units and Clinical Trials (SCReN). It is a research support structure promoted by the Carlos III Health Institute (ISCIII). Its objective is to facilitate the performance of clinical research of quality and excellence, through the identification of relevant hypotheses, the provision of adequate support to convert them into projects developed safely and efficiently, and the dissemination and translation to the Health System.

The Clinical Research Unit of the IIS Aragón fundamentally participates in the Regulation and Monitoring Program. One of its main functions is to capture projects from their conception, develop them, monitor them, give them continuity and act as a guarantor that legal responsibilities are met and that adequate protection is given to patients who participate in the projects. studies. Likewise, it also highlights the function of advising researchers on aspects related to the preparation of proposals, shaping ideas and hypotheses and supporting key processes for the execution of research projects.