The phase I clinical trials unit of the Medicines Research Center (CIM) of the Research Institute of the Hospital de la Santa Creu i Sant Pau – IIB Sant Pau has renewed the Certificate of compliance with the rules of good clinical practice (BPC) after having passed the inspection by the Direcció General d’Ordenació i Regulació Sanitària of the Generalitat de Catalunya.
This certificate recognizes compliance with the requirements necessary to carry out phase I clinical trials or first administration of medicines in humans, in accordance with the principles of good clinical practice (GCP) in force in the European Union and the technical and sanitary requirements of the phase I units published by the Department of Health of the Generalitat de Catalunya.
The CIM carries out phase I efficacy and tolerability clinical trials, pharmacokinetics, drug metabolism and interaction studies, bioequivalence studies and first studies in humans.
