Phase 1 Site Support: an innovative project to help face the challenges of phase I research in Italy

In phase I clinical trials a new drug is usually tested in humans for the first time. As they carry the highest potential risk for the subjects involved, phase I studies are carried out in compliance with strict ethical principles and regulatory requirements.

In 2015, the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) issued the Determina 809/2015, which establishes minimum requirements for any institution involved in phase I clinical trials, both clinical units and laboratories. Indeed, the institutions that want to conduct phase I clinical trials must be compliant with the minimum requirements described in the Determina, and notify them through a self-certification to be transmitted as per the Determina 451/2016.

Since its coming into force, AIFA Determina 809/2015 has imposed high-quality standards for the conduction of phase I studies in Italy, posing new challenges to clinical units and laboratories which intend to self-certify their compliance with the requirements.

On February 23rd 2021 ClinOpsHub launched an innovative project, Phase 1 Site Support, aimed at providing support to medical institutions involved in phase I studies in the long and challenging path of qualification, self-certification and maintenance of the requirements described in AIFA Determina 809/2015.

Thanks to their expertise and knowledge, Phase 1 Site Support team intends to help units and laboratories conduct high-quality phase I research, with the result of increasing the number of phase I clinical trials in Italy and therefore broadening the range of therapeutic options available for patients.

Phase 1 Site Support team provides several services:

• Clinical site staff training;

• Quality Assurance and Auditor in outsourcing;

• Writing and revision of SOPs;

• Vendor identification.

If you want to learn more about Phase 1 Site Support team and services, visit our website Phase1.it.