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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.


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1 Comment


Raveena Aher
Raveena Aher
Jun 15, 2021

Hey thanx for sharing this blog over here. It seems useful to start career in clinical research. We will look foreward for more updates.


https://www.technobridge.in/clinical-research-course.html

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