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. 

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The main activities are: 

• Writing and revision of Standard Operating Procedures (SOPs)

• Staff training management

• CAPA management 

• Support during audits and inspections.

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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.

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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.