Clinical research platform

GINYS-IRSP-010
Rosa M. Antonijoan Arbós
Coordinadora

c/ Sant Quintí 77-79  08041 Barcelona

The Centre for Drug Research (CIM) began its activities in 1983, in collaboration with the Clinical Pharmacology Department of the HSCSP and the Pharmacology and Therapeutics Department of the Autonomous University of Barcelona (UAB).
Funcions
The CIM conducts clinical trials with drugs and clinical research in two areas:
  • RESEARCH AS A BUSINESS UNIT
  1. Phase I clinical trials (of no therapeutic interest for participants) in special populations and healthy volunteers (bioequivalence, tolerability, pharmacokinetics and pharmacodynamics, first administration in humans).
  2. Collaboration with HSCSP researchers in conducting phase II, III and IV clinical trials.
  • RESEARCH IN NEUROPSYCHOPHARMACOLOGY
  1. Evaluation of the effects of psychotropic drugs and other substances active in the central nervous system on the sleep-wake cycle:Studies of effects during wakefulness (behavioural safety).
  2. Studies of effects during wakefulness (behavioural safety).
  3. Studies of effects on sleep quality and architecture.

Equipment

To carry out these functions two different areas are distinguished:

CARE AREA (4 SECTIONS)
  • Admissions, with 24 beds (in four modules) that allow 100% continuous visual control and two beds for polysomnography studies.
  • Outpatient area, with four single rooms equipped for medical, physical and neuropsychological and psychomotor performance testing.
  • Rest and services area: showers, toilets, kitchen, diningroom, leisure room.
  • Restricted area for drug storage and for the processing and storage of biological samples.
DATA MANAGEMENT AND PROCESSING AREA
  • Five computerized offices to carry out non-experimental clinical trial activities.
    Monitors’ area (1 room).
  • Temporary documentation archive (1 room).

Staff

Rosa M. Antonijoan Arbós | rantonijoana@santpau.cat | ORCID | PRC Page

INSTITUTE

IRSantPau - Institut de Recerca Sant Pau

Sant Quintí, 77-79

08041 Barcelona http://www.recercasantpau.cat/

DOMAINS RIS3CAT

  • Education and knowledge generation system
  • Industrial system
  • Socio-sanitary system

CATEGORIES

  • CLINICAL TRIALS

RATES AND ACCESS

Availability Level: High
Access Procedures:

Open. Conditions

QUALITY CONTROL

GCP (or BPC) Certificate
Certificate of Good Clinical Practice - AEMPS Good Clinical Practice (GCP) is a term coined in the United States that encompasses a set of rules aimed at guaranteeing the rights of subjects participating in a clinical trial, ensuring the quality of data, and avoiding errors in clinical research.
Status: Active

FACILITIES NETWORKS

BCTP – Barcelona Clinical Trials Platform
The BCTP has as its great challenge to advance the arrival of innovative treatments to patients in Catalonia. BCTP needs to improve the coordination, integration, quality, inclusiveness and speed of clinical research. This will be thanks to the optimization and homogenization of the clinical research processes of its members, as well as the human and technological potential of the centers. In addition, the BCTP will function as a dissemination platform to attract new studies from outside Catalonia.
Reach: Catalonia
Status: Active
REGIC – Network of clinical research management entities
REGIC is the first association of clinical research management organizations created in Spain at the request of professionals, to share experiences and create a space for interaction and training in the management of healthcare R & D & I.
Reach: Spain
Status: Active
SCREN – Clinical Research Units and Clinical Trials
SCReN: Support for multicenter clinical trials Achieve an advanced level of technical competence in the processes related to the development and management of clinical research, ensure compliance with legal requirements and the competence of researchers participating in platform studies on methodological aspects and PCBs. others.
Reach: Spain
Status: Active
CERCA - Ginys