Top Law Firm’s Italian Clinical Trial Specialists Discuss Challenges & New Opportunities Conducting Clinical Trials in Italy During COVID-19

Top Law Firm’s Italian Clinical Trial Specialists Discuss Challenges & New Opportunities Conducting Clinical Trials in Italy During COVID-19

The EU Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agency (HMA) published new guidelines on April 28, 2020 on the management of clinical trials during the COVID-19 pandemic. Serving as a set of harmonized recommendations across the EU, the regulators in Europe are concerned about the unprecedented impact wrought by the COVID-19 pandemic. Because SARS-CoV-2 has fundamentally constrained how clinical trials are actually conducted, Member States are afforded new flexibility and procedural simplifications during the raging public health crisis:  top of mind is the safety of trial participants—and research staff—across the EU while ensuring that ongoing quality data generation is done so in a quality and consistent manner.

A Major Problem but Also an Opportunity

Member States have implemented unprecedented measures to deal with threats from the SARS-CoV-2 virus and their impact on the administration of clinical trials. From limited access to public facilities, including hospitals and clinics, to the need for patients to self-isolate and even quarantine of trial participants the status quo is gone in Europe for clinical research.

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