Unifarm University Consortium (Consorzio Universitario Unifarm, UNIFARM) was founded in Catania in 2002 by Filippo Drago, Professor of Pharmacology at the School of Medicine, University of Catania, in cooperation with the University of Catania and twelve major multinational pharmaceutical companies. In the same year the Research Centre in Clinical Pharmacology the first in Central...read more

UNIFARM is a CRO registered at  the Agenzia Italiana del Farmaco (Italian Authority for Drugs, AIFA), compliant with the requirements of the DM (Ministerial Decree) dated March 31, 2008 on clinical trials and therefore able to provide services such as: clinical study design; project management; preparation of study protocols and other regulatory documents; approval procedures...read more

UNIFARM has implemented a Quality System in line with national and international regulations to ensure high level of service and client satisfaction. Indeed, this is one of the main objectives of UNIFARM and is constantly pursued through the involvement of all the personnel in a quality process based on the assumption of individual responsibility, as well as through the implementation of systems and procedures...read more

Monitor Consulting

UNIFARM performs monitoring activity with monitors compliant with the requirements of the DM  dated March 31, 2008.

 
In particular the Monitor is responsible for:
verifying that the clinical studies are performed, recorded and reported according to Good Clinical Practice (GCP) and other applicable laws;
performing a pre-trial monitoring visit to document that the site is suitable for the trial;
performing a trial initiation monitoring visit to document that the trial procedures were reviewed with the investigator and trial staff;
checking the accuracy and completeness of the documents in order to ensure the targets are reached throughout the study
performing monitoring visits during the study according to the  monitoring plan and applicable SOP;
discussing problems with the medical staff and promptly send out monitoring reports
performing close-out monitoring visit to document that all activities required for the close-out have been completed.

 

Unifarm è un Centro di Saggio (CdS) certificato dal Ministero della Salute,
in Buona Pratica di Laboratorio (BPL)