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Clinical Research Unit Ana Aldea

The IMIM's Clinical Research Unit (CRU) is accredited by the Catalan Government (Generalitat de Catalunya) as a Phase I Clinical Trial Unit. It is located in the PRBB building, next to Hospital del Mar.

In this space, clinical drug trials are conducted on healthy volunteers, as well as nutritional studies and other support activities necessary for developing the trials in various therapeutic areas.

The unit dates back to the early 1980s, when the Pharmacology Department at Hospital del Mar developed several pioneering initiatives related to treating heroin addicts, and set up a Phase I unit. It is currently managed by the Integrated Pharmacology and Systems Neuroscience research group.

What type of studies can be carried out?

• Clinical trials on healthy volunteers, with no therapeutic objective:
• Pharmacokinetic and metabolism studies (including bioequivalence, tolerability, first administration in humans single or multiple dose trials)
• Pharmacodynamic effects: subjective effects, cardiovascular safety
• Behavioural effects, stress assessment
• Phase I and phase II efficacy and tolerability clinical trials
• Phase I clinical trials on special populations (paediatrics, older adults, Down's or Fragile X Syndrome sufferers, toxic and addictive substance users)
• Drug-drug interaction studies
• Nutritional intervention clinical trials
• Health benefits of nutrition related to cognitive performance
• Drug-food interaction studies
• Collaboration in phase II-IV clinical trials: screening visits, sample extraction, biopsies, surveys
• Renal function measurement studies
• Excretion studies as part of doping control
• Determination and identification of drugs and metabolites in blood, urine, hair, saliva, and other biological materials. Targeted metabolomic studies.

Why choose us?

The Clinical Research Unit (CRU) can hold 12 volunteers in the admissions area and has 3 small clinics for screening visits and outpatient assessments.

High recruitment capacity, database of more than 500 volunteers.

Quality policy: The Unit has Standard Working Procedures to guarantee patient rights and safety as well as the quality of the data obtained from the studies, in compliance with the Good Clinical Practice Guidelines and current clinical trial regulations.

The Unit is periodically accredited by the Catalan Government and its activity is audited by the IMIM Quality Unit.

The team:

• includes multidisciplinary professionals (clinical pharmacologists, nurses, pharmacists, neuropsychologists, etc.) specialised in clinical research activities.
• has collaborated in the implementation and development of clinical trials promoted or co-promoted by different research groups in various therapeutic areas, for the pharmaceutical and food industry.
• works in close collaboration with the Integrated Pharmacology and Systems Neuroscience Group and the World Anti-Doping Agency.
• is linked to the Mar Health Park (Hospital del Mar), as well as Pompeu Fabra University and the UAB (Universitat Autònoma de Barcelona).