The fundamental purpose of the Clinical Research Platform (CRP) is to create the infrastructure that will support clinical research at hospitals that can promote the population’s health and well-being, through the management of patient-based clinical research, consolidating clinical trials without commercial interest and boosting privately-promoted clinical studies in the search for excellence in both fields.
The Biodonostia HRI Clinical Research Unit forms part of the Clinical Research and Clinical Trials Units Platform at the Carlos III Health Institute, associated to the European network ECRIN (European Clinical Research Infrastructure Network). It has now renewed its membership of the new ISCIII Platform lending support to R&D&I in Biomedicine and Health Sciences – Support for clinical research.
Included in the Clinical Trials Unit’s scope of action are trials with medication, health products and those that study other therapeutic health operations. Also included are randomized clinical trials with intervention for diagnostic, preventive or service purposes.
The Donostialdea IHO services that have traditionally been more active in this area, according to number of clinical trials (2015), are:
The Clinical Research Unit is also responsible for coordinating and monitoring clinical trials and other clinical research studies, mainly of an independent nature, as well as providing support for those services that need assistance due to lack of personnel. For this purpose, the Biodonostia HRI coordinates the personnel involved in the clinical trials at our hospital, setting a common objective for Monitors, Study coordinators y Data Managers: to safeguard the rights and safety of patients taking part in a clinical trial to improve their care and quality of life as far as possible.
Through this Unit, the Institute offers advice and support in matters related to regulation and processing, economic aspects, medication management and performance of the clinical trial.
The advice and support offered includes those areas that are the promoter’s responsibility and also particularly specialised areas such as those related to documentation, filing, monitoring and follow-up of clinical trials.
The Unit is located on the ground floor of the Biodonostia HRI and is equipped with facilities to support the clinical research, a meeting room, a room for drawing samples for the patients taking part in the clinical trials, and a centralised sample collection point/laboratory.
The objectives of the Clinical Research Unit are:
- To increase the volume and quality of clinical trials activity, in line with the R+D+i plan.
- To promote the transfer of the results from clinical research to clinical practice, which will have an effect on the innovation and quality of healthcare.
- To increase clinical trials research without commercial interest, whether promoted by Health System researchers or by external bodies.
- To carry out smooth and efficient management based on optimising the time and procedures involved in setting up a clinical trial.
- To foster transparency in the flow of information related to the clinical study.
- To develop all clinical studies in accordance with international guidelines on ethical and scientific quality – Good Clinical Practice (GCP).
The platform manages its processes according to the guidelines of Standard UNE-EN ISO 9001:2015, while its Quality Management System is certified by AENOR. This lends added value to the work carried out by the Platform, particularly with a view to external applicants for its services, and fosters trust regarding the extent of the Quality applied to the processing of their requests.