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Guidance on the management of clinical trials during the Covid-19 Pandemic

By Anita Falezza

21 December, 2020

Article

Guidance on the management of clinical trials during the Covid-19 Pandemic

Anita Falezza

21/12/2020

Article

How Does the FDA’s Updated Clinical Trial Guidance Impact Assion?

The global COVID-19 pandemic has had a profound impact on the world’s health systems, with supply chains stretched and public health officials overwhelmed. Amidst the chaos, it has been necessary for clinical trial sponsors to adjust their protocols and recommendations around the rights, safety and wellbeing of trial participants.

This has been most keenly felt in The Food and Drug Administration (FDA)’s ‘Guidance on Conduct of Clinical Trials of Medical products During COVID-19 Public Health Emergency’, initially published in March 2020.

Such is the nature of the pandemic, however, that expert opinion and knowledge of the virus changed dramatically in the following nine months, leading to the announcement on December 4th 2020 that the FDA has reviewed and updated its guidance.

What are the changes?

Put simply, the changes are intended to make existing guidance on the management of clinical trials clearer for sponsors.

There is specific advice on ensuring the safety of trial participants, maintaining compliance with Good Clinical Practise (GCP), and reducing the danger of trials’ integrity being compromised by COVID-related problems.

Ultimately, a major theme of the FDA’s guidance has been to move towards virtual trials wherever possible; this requires innovative solutions to avoid stalling of progress.

How is Assion adapting?

At Assion, we have a successful history of supporting companies in clinical program development, and we have been able to maintain this success throughout the pandemic.

Because our team is dedicated to providing innovative strategic solutions to optimize clinical development and ensure regulatory approval, we have developed a number of exciting methods for navigating new, covid-19 related challenges whilst following guidance.

If you’d like to hear more about these strategies, contact us today at enquiries@assiongroup.com.

Anita Falezza

Founder

Anita Falezza founded Assion in 2020, having previously founded Regulatory Pharma Net s.r.l. in 1999. Anita has held various positions in the pharmaceutical industry since 1989. With 30 years’ experience in the market her activities are focused on the consulting and strategic coordination of Drug Development, Regulatory Affairs and Market Access projects across international markets, providing strategic advice for interacting with international and national regulatory authorities (e.g. EMA, FDA, BfArM, AIFA, etc.), maximising the use of the regulatory mechanisms using an interdisciplinary approach to obtain regulatory and market access goals.

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