The Clinical Research Platform of the Biodonostia Health Research Institute is 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 platform 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 platform, the Biodonostia HRI 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.
Included in the Clinical Trials platform’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 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).