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CLINICAL RESEARCH AND CLINICAL TRIALS UNIT (UICEC)

 

What is?

 

The Clinical Research and Clinical Trials Unit (UICEC) is one of IdISBa's research support platforms and its main function is to provide support to researchers in the development of both independent and non-promoter clinical research projects as in commercial promoter clinical trials. The unit offers both scientific and administrative support, also assisting with the regulatory and clinical management, monitoring and pharmacovigilance aspects of independent clinical trials.

 

The UICEC-IdISBa service portfolio makes available to researchers the performance of tasks related to the design, planning and implementation of clinical studies, as well as their coordination and development, including nursing and management tasks of biological samples. Data management and security monitoring tasks are also carried out.

 

Since 2021, the UICEC-IdISBa has been integrated into the Platform of Clinical Research Units and Clinical Trials SCReN (Spanish Clinical Research Network) of the Carlos III Health Institute (ISCIII).

 

SCReN is a cooperative network, where clinical research units (UICs) from 34 different centers from 14 autonomous communities are associated. Its general objective is to facilitate the performance of clinical research of quality and excellence, by providing adequate support to scientifically relevant proposals, facilitating their correct development, dissemination and final translation into the Health System.

 

The unit is a multidisciplinary group and is made up of professionals from the biomedical field (pharmacologists, epidemiologists, biologists, statisticians, research nurses, laboratory technicians and administrators) experts in the field of clinical research.

 

 

Coordination

Francisco de Borja García-Cosío Piqueras

Aina Soler Mieras

 

Methodological and statistical support

Guillem Frontera Juan

Aina Millán Pons

 

Clinical research nursing

Montserrat Alzina Servera

Úrsula Sastre Terrassa

Angel Rios Olivencia

 

Data manager

Daniel Ramis Cabrer

 

Biological sample management

Elena Rayó Gago

 

Project management and monitoring

Aina Matas Palau

Kaoutar Ziani Akrout

 

Administrative support

Cristina Contreras Vaillo

 

Services Portfolio

 

The UICEC offers services to researchers who wish to carry out clinical research studies in their responsibilities as promoters in compliance with the legislation and standards of Good Clinical Practice (GCP).

 

  1. Methodological and statistical support
    1. Methodological advice in the design of research protocols for both observational and experimental or quasi-experimental studies
    2. Advice and statistical analysis
    3. Design, preparation and validation of eCRFs
    4. Digitization of eCRFs
  2. Pre-start clinical trial
    1. Identification and selection of centers
    2. Preparation and submission of general documentation and application to the regulatory agencies
    3. Payment of fees (CEIm and/or AEMPS)
    4. Clinical trial registration and maintenance of the record
    5. Clarification and amendments to regulatory agencies and/or ethics committees
    6. Certification and release of medication batches
    7. Preparation of the monitoring plan
    8. Collection of signatures and sending them to the promoter
    9. Application for civil liability insurance policy (selection and contracting, processing of the policy)
    10. J. Management of contracts with the centers
    11. k. Elaboration and maintenance of the promoter's and the researcher's file
  1. Drafting or adaptation of patient information sheets and informed consent forms
  1. Clinical trial development
    1. Project management
    2. Monitoring
    3. Coordination of the study
    4. Economic and administrative management of payments
    5. Nursing
    6. Biological sample management
    7. Data manager
    8. Financial management of the study or project
  2. Completion and closure of clinical trial
    1. Query resolution and database termination
    2. Closing visits
    3. Drafting of the final study report
    4. Medical writing
  3. Pharmacovigilance
    1. Plan for the implementation of pharmacovigilance activities
    2. Updating of documentation on security information
    3. Reconciliation SAEs
    4. Drafting and processing of safety reports

 

Spaces and equipment

 

The UICEC is located in module I of the floor -1 of the Son Espases University Hospital. It occupies a useful surface of 259.45m2.

These spaces are equipped with:

 

  • 3 outpatient offices
  • 1 study monitoring room
  • 1 methodological and statistical support office
  • 1 archive of active and passive studies
  • Rooms for preparation, separation and preservation of biological samples and storage of materials

 

The material with which the unit is equipped is as follows:

 

  • Electrocardiograph with wireless transmission to the server
  • Tensiometers
  • Scale with cutter
  • DEXA density meter
  • Pulse oximeters
  • Spirometer
  • Vascular Doppler
  • Defibrillator
  • Bunk beds
  • Refrigerated centrifuge
  • -20ºC and -80ºC freezers
  • -4ºC freezer
  • Cardiorespiratory arrest cart
  • Electronic data collection notebook
  • Statistical analysis programs (SPSS, R)
  • Videoconferencing equipment
  • Electronic data capture design (REDCap)

Direction

Clinical Research and Clinical Trials Unit (UICEC)

Floor -1, Module I, Son Espases University Hospital

Valldemossa road 79

07120 Palma de Mallorca

 

Information and administration

Marga Frontera

marga.frontera@ssib.es

Tel.: (+34) 871205334 Ext. 66310

 

 

APPLICATION FORM

Please read these instructions:

 

  1. Open the application and save it on the computer. 
  2. Complete the application fields. 
  3. Save the changes made. 
  4. Attach the application and send it to marga.frontera@ssib.es
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