Audit History

Over the course of 11 years, the sites participating in clinical trials managed by SMO-Pharmina have undergone more than 130 audits. According to the reports of Sponsors or CRO auditors, the centers did not reveal critical or major deviations. Two centers have undergone FDA Inspections and no Form 483 was issued. 

SMO-Pharmina is inspected annually by ISO international auditors and contractor CROs.