NAME Clinical Research Platform
The purpose of the Clinical Research Platform is to create the infrastructure that will support clinical research at hospitals, 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. Included in the 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.
FIELDS OF APPLICATION
Digital health
Electromedical devices
In-Vitro diagnostics
Medical Image
Orthopedic and rehabilitation Technology
MOST OUTSTANDING EQUIPMENT AND COMPONENTS
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Extraction room for sample collection
Extraction room for sample collection
SERVICES OFFERED BY THE ASSET
Advice on medication management and in the execution of the clinical trial
Selection of a CRO if necessary
Advice on the suppliers’ contract management
Contracts with suppliers participating in the study
Advice, management and support for the preparation and monitoring of administrative documentation related to the project.
Administrative documentation related to the project.
Archive management
Clinical Trials documentation archive.
Coordination
Study / patient coordination
Documentation Management Support
Ethic and regulatory authorities evaluation.
Extraction and processing of biological samples
Obtaining and processing the samples indicated in the protocol established in the study.
Monitorization
Study data monitoring
Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies
Pharmacokinetic (PK) and Pharmacodynamic (PD) Studies
Study coordination and monitoring
Logistics and actions
Study design support
Protocol design, CRF and Patient Information Sheet (PIS) and launch of different clinical studies
ENTITY MANAGING THE ASSET
Contact person:
IIS Biodonostia
amaia.delvillar@biodonostia.org