Quality Assurance and auditing activities

ClinOpsHub has a dedicated department specialised in GCP Quality Assurance and Auditing activities. The ClinOpsHub professionals support Sponsors/CROs and experimental centers in order to be compliant with the Italian regulatory framework and international ethical standards. 

The main activities are: 

  • Writing and revision of Standard Operating Procedures (SOPs)

  • Staff training management

  • CAPA management 

  • Support during audits and inspections.

In particular, ClinOpsHub shows a strong commitment in helping phase 1 clinical centers to be compliant with the Determina AIFA n. 809/2015 in order to properly conduct phase 1 clinical trials in Italy.

We provide the following services:

  • Site Qualification Visit to verify the center status, to highlight the missing requirements and provide support for the self-certification.

  • Quality Assurance and Auditing Activities to be in compliance with the quality requirements described in Determina AIFA n. 809/2015.

ClinOpsHub has extensive experience in the field supporting more than 20 phase 1 units in Italy.