Technical scientific services

Clinical Research Support Unit (USIC)

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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:

  1.  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.
  1. 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.

Documents

Operational rules (ESP)

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Information (ESP)

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Pharma request (ESP)

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Contact details

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Dr. Joan Antoni Schoenenberger

Human resources

  • Dr. Joan Antoni Schoenenberger Arnaiz

    Scientific director of SCTFarma

  • Laura Rumi Carrera

    Head of the SCTFarma and clinical trials pharmacist

  • Petya Vladeva Valcheva

    Clinical trials coordinator

  • Monica Baldrich Mora

    Clinical trials nurse-coordinator

  • Aida Moroba Estor

    Laboratory technician

  • Alba García Ribas

    Clinical trial monitor and assistant

  • Elisa Soler Lauroba

    Clinical trials pharmacist

  • Sara Vidal Puig

    Clinical Trials Coordinator

  • Judit Herrera Duran

    Clinical trials nurse-coordinator