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
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.