Clinical Research and Clinical Trials Unit (UICEC)

The Clinical Research and Clinical Trials Unit (UICEC) of INCLIVA acts as an institutional CRO (Clinical Research Organization) that offers comprehensive coverage for the development of clinical studies, providing methodological, regulatory and management support in all their phases: design, initiation, monitoring and closure. Its scope of action includes both clinical trials with medicinal products and investigations with medical devices, also incluiding clinical trials with advanced therapies.

The Clinical Research and Clinical Trials Unit (UICEC-INCLIVA) is part of the Support Platform for R&D&I in Biomedicine and Health Sciences of the Carlos III Health Institute (ISCIII). Its misión is to collaborate with research staff in the promotion of independent clinical studies, offering support in the comprehensive management of projects and in monitoring tasks.

Likewise, the Unit provides external sponsors with a range of specialized services aimed at the initiation, management and monitoring of clinical studies.

The main functions of the Unit are:

• Methodological and regulatory advisory services.
  • Collaboration in the development of protocols of clinical trials with medicinal products and clinical investigations with medical devices, patient information sheets, informed consent documents, and all the documentation necessary for the correct development of the study, according to current regulations.
  • Advisory on the design and needs of the study.
  • Evaluation of the economic feasibility of the trial and search for funding.
• Initiation
  • Selection of the participating sites.
  • Management of regulatory approvals (AEMPS (Agencia Española del Medicamento y Productos Sanitarios – Spanish Agency of Medicines and Medical Devices) and CEIm (Ethics Committees for Investigation with medicinal products)).
  • Management of contracts with participating sites.
  • Registration and maintenance in clinicaltrials.gov and in the Spanish Clinical Trials Registry (REEC).
• Monitoring
  • Creation of the monitoring plan.
  • Initiation, monitoring, and close-out visits.
• Development of clinical study activities
  • Ensuring regulatory compliance.
  • Communication with the sponsor and regulatory agencies.
  • Preparation, submission and follow-up of notifications to the agencies.
  • Preparation and submission of reports (annual and final).
  • Creation, updating and custody of the Trial Master File (TMF).
  • Coordination and support in the maintenance of the Investigator File and the Pharmacy File.
  • Coordination of the documentation and traceability of the medication.