Quality Policy

The purpose of SMO-CLINICA is to provide access to a large number of patients through our dedicated Research Centres while guarantying Quality & Ethics.

SMO-CLINICA’s management sets high standards for the Operations based on western management practices & client-oriented approach. 

The SMO's model brings the advantage that all documentation (source, CRF) is standardized across all clinics which substantially lowering monitoring time.

 

 

Quality assurance key element is to ensure that all clinical trial activities meet applicable ethical standards and regulatory requirements.

A strong compliance is also observed with SOPs, Good Clinical Practices and ICH guidelines.

SMO-CLINICA observed SOPs in accordance with the principles of ICH GCP guidelines and industry quality standards.

The SOPs are an integral part of our Quality Management System and the standard against which all activity is monitored and measured.

 

 

This function also ensures that on-site audits and training procedures are conducted on a regularly basis to maintain excellence at all SMO-CLINICA's Research Centres.

SMO-CLINICA mandates QA auditors that regularly conduct audits according to internal audit plan and SOPs.

To date, there has been no major findings out of the Sponsors’ audits run at SMO-CLINICA Research Centres leading to a high level of satisfaction of our clients.