Clinical Research Support Unit (USIC)
The Clinical Research Support Unit is located on the ground floor of the Biomedicine II building. Its mission is to support the clinical research groups of the IRBLLEIDA/HUAV in everything they need to carry out any clinical trial.
This support may include:
- Advising the research groups on the design of their own studies.
- Coordinating the clinical trial: from the submission of initial documentation to the completion of the study, both in the administrative and care areas.
- Promoting patient recruitment.
- Monitor own studies.
- Ensure compliance with the Standards of Good Clinical Practice (GCPP) in clinical studies.
AREAS:
- The Clinical Area: supports the development of clinical research and offers all the necessary infrastructure to carry out the trials, it has:
- Fully equipped medical offices for the examination and monitoring of patients participating in clinical studies. Equipped with computers connected to the hospital network (SABE).
- Laboratory for processing clinical samples with BioII hood, centrifuges, incubator and freezers.
- Laboratory for drug preparation by assays.
- Ambient medication storage room with restricted access and controlled temperature.
- Temperature-controlled freezer and refrigerator room.
- Archive for clinical study documentation.
- Meeting rooms available for monitoring and/or external audits.
- The Management Area: its main function is to support studies, specifically:
- Design and writing of a protocol, CRD and study consent.
- Preparation of necessary files: investigator, sponsor, pharmacy.
- Monitoring plan: initiation, monitoring and closure visits to other centres.
- Submission of initial documentation to CEIms and regulatory agencies.
- Notifications to regulatory agencies during the study: annual reports, amendments...
- Resolution of queries and databases.
STAFF:
It is a functional unit made up of: nurses, laboratory technicians, biologists and pharmacists. These professionals carry out tasks of: study coordinator, study nurse, data manager, CTA, monitor, sample processing and pharmacy.
Human resources
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Dr. Joan Antoni Schoenenberger Arnaiz
Scientific director of SCTFarma
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Laura Rumi Carrera
Head of the SCTFarma and clinical trials pharmacist
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Petya Vladeva Valcheva
Clinical trials coordinator
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Monica Baldrich Mora
Clinical trials nurse-coordinator
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Aida Moroba Estor
Laboratory technician
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Alba García Ribas
Clinical trial monitor and assistant
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Elisa Soler Lauroba
Clinical trials pharmacist
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Sara Vidal Puig
Clinical Trials Coordinator
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Judit Herrera Duran
Clinical trials nurse-coordinator
