The Clinical Research Platform is part of the Platform of Clinical Research Units and Clinical Trials - SCReN of the Carlos III Health Institute, associated with the European network ECRIN (European Clinical Research Infrastructure Network).
The Platform includes different professionals:
The different profiles guarantee high-quality project management and services with an intermediate level of English. All of them certified and trained in Good Clinical Practices and internal procedures (SOP) under applicable national laws.
Within the scope of action of the Clinical Research Platform are trials with medications, medical devices, cell therapy and those that study other therapeutic health interventions. Also included are randomized clinical trials with intervention for diagnostic, preventive or service purposes. Proof of concept and trials in the confirmatory phase.
The Platform offers advice and support on aspects related to the design of protocols, case report form, patient information sheet and consent form, regulatory and processing aspects, economic issues, medication management, trial performance and management of data.
The advice and support offered includes aspects that are the responsibility of the sponsor and also especially specialized aspects such as those related to the documentation, archiving, monitoring and monitoring of clinical trials.