Clinical research unit

La USIC està situada a la planta 13 de l'Àrea Maternoinfantil (AMI) de l'HUVH i posa a disposició de la investigació clínica els següents serveis i espais: 7 consultoris totalment equipats pel seguiment i exploració dels pacients inclosos en estudis clínics, sala per a extraccions o infusió de medicació, un laboratori pel tractament i conservació de mostres clíniques, un arxiu per a la documentació de l’estudi, i espais per a reunions, monitoritzacions i/o auditories; així mateix dona suport d’infermeria de recerca per a les extracció, processament i gestió de mostres biològiques, i altres proves complementàries.

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Institutional Contacts / Head of Facilities

Provisional Contacts

Ana Aldea Perona | CRU Unit |  aaldea@imim.es  |  ORCID  

Ana Aldea Perona | CRU Unit |  aaldea@imim.es  |  ORCID  

Xavier Mayol | Coordination of Internal Services and Research Laboratories |  xmayol@imim.es  | 933 160 400 |  ORCID 

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Equipments & Services Offered

The Clinical Research Unit (URC) has facilities with capacity for 12 volunteers in the admission area and 3 dispensaries to carry out selection visits and outpatient assessments. High recruitment capacity, database of more than 500 volunteers. Quality policy: The Unit has Standard Operating Procedures to guarantee the rights and safety of patients and the quality of the data obtained from the studies, complying with the Good Clinical Practice Standards and current regulations on clinical trials. The Unit is periodically accredited by the Generalitat de Catalunya and its activity is audited by the IMIM Quality Unit. The team of professionals that makes up it: It is multidisciplinary (clinical pharmacologists, nurses, pharmacists, neuropsychologists, etc.) specialized in clinical research activities. They have collaborated in the launch and development of clinical trials promoted or co-promoted by different research groups in various therapeutic areas, by the pharmaceutical and food industries. They work in close collaboration with the Integrated Pharmacology and Systems Neuroscience Group and the World Anti-Doping Agency. They are linked to the Parc de Salut Mar (Hospital del Mar) and the Pompeu Fabra and Autònoma Universities of Barcelona.

What studies can be performed? Clinical trials without a therapeutic objective in healthy volunteers: Pharmacokinetic and metabolism studies (including bioequivalence, tolerability, first administration in humans, single dose or multiple doses) Pharmacodynamic effects: subjective effects, cardiovascular safety. Behavioral effects, stress assessment. Phase I and phase II clinical trials of efficacy and tolerability. Phase I clinical trials in special populations (Pediatrics, elderly, Down syndrome or Fragile X, users of toxic or addictive substances) Drug-drug interaction studies Nutritional intervention clinical trials. Health benefits of nutrition in cognitive performance Drug-food interaction studies Collaborations in phase II-IV clinical trials: screening visits, sample extractions, biopsies, questionnaires. Renal function measurement studies. Excretion studies in the framework of doping control Determination and identification of drugs and metabolites, in blood, urine, hair, saliva and other biological matrices. Targeted metabolomic studies.

Categorització

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CERCA GINYS Categories

GINYS-IMIM-008

Institutional Quality

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