Parexel's COVID-19 expert content
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Learn MoreHow COVID-19 May Redirect US Healthcare Reform Priorities
About the Authors Frank F. Zhou is a Senior Analyst in the Health...
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Learn MorePart 1: Navigating Patient Privacy During Remote Monitoring in the Age of COVID-19
Patient Privacy Patient Privacy is a mainstay of clinical trials and is incorporated into the International Council on Harmonization (ICH) E6 (R2) Good Clinical Practices (GCP) guideline1. ...
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Learn MorePerspective on the FDA enforcement policy for ventilators, accessories and other respiratory devices during COVID-19
Background There is an insufficient supply of ventilators to treat patients around the globe desperately in need of ventilatory support due to the Coronavirus pandemic. In response to the...
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Learn MoreFDA Launches Coronavirus Treatment Acceleration Program (CTAP)
To provide structure and context to the measures the Food and Drug Administration (FDA) is taking to accelerate the review and availability of treatments for COVID-19, the Agency announced a...
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Learn MoreVirus Filtration: a key manufacturing step keeping medicines safe, including from emerging viruses like COVID-19
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View NowParexel's COVID-19 task force
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Learn MoreHow COVID-19 Could Impact Digital Health
Key Takeaways• The COVID-19 pandemic could accelerate adoption of some digital health technologies...
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Learn MoreWill Healthcare Ever Be the Same Again After COVID-19?
About Health Advances Health Advances is a strategy consulting firm that helps clients...
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Learn MorePerspective on Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency
In summary FDA is moving quickly to implement emergency use applications (EUAs) policy to provide flexibility to those manufacturers of face masks and respirators to meet the need of medical...
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Learn MoreNew version 2 “The guidance on the management of clinical trials during COVID-19 (Coronavirus) pandemic” published on European Commission we
After only one week since publishing of the first version on 20-Mar-2020, an updated version 2 of “The guidance on the management of clinical trials during COVID-19 (Coronavirus) pandemic” has...
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Learn MoreNew global frameworks for managing clinical trials during COVID-19 emergency
As global health authorities react and adjust to responding to the emerging COVID-19 threat to public health, one of the results has been more guidance, published much more often and without going...
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Learn MoreWhere do we stand with COVID-19?
Since the first case of coronavirus (COVID-19) was identified in December 2019, cases have been confirmed on every continent but Antarctica, prompting the World Health Organization to declare...
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Learn MoreBack to the future – Are you prepared to meet unprecedented demand to use old drugs for new purposes?
There has been significant momentum to begin repurposing existing drugs to find either prophylactic or acute treatments for COVID-19. These activities could result in further strains on...
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Learn MoreCOVID-19 pandemic and regulatory guidelines on clinical trial conduct; similarities and differences between regions
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Learn MorePerspective on Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency
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Learn MoreCOVID-19: Regulatory Impact
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Learn MoreFDA takes action to accelerate availability of COVID-19 diagnostic tests
On February 29, 2020, the U.S Food and Drug Administration (FDA) published an “immediately in effect guidance” that is designed to directly address the acute shortage of diagnostic tests currently...
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Learn MoreCOVID-19 isn’t putting FDA out of the compliance business – Be ready for inspection alternatives
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Learn MoreSolutions for sustainable supply chains in a period of global tumult
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Learn MoreDesk-based Health Authority inspections: A risk-based approach to compliance
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