Coronavirus Disease-2019 Clinical Trial Case Studies Within the Biotechnology and Clinical Research Organizations Industry

Authors

  • Melanie K. Pearce Author
  • Nathanael E. Hughes Author

Keywords:

World Health Organization (WHO), global pandemic, Coronaviridae

Abstract

On March 11th, 2020 the World Health Organization (WHO)
declared the novel coronavirus disease-2019 (COVID-19)
outbreak a global pandemic. Coronaviruses are non-segmented
positive-sense ribonucleic acid (RNA) viruses in the Coronaviridae
family, which typically affects the respiratory, gastrointestinal,
hepatic and neurologic systems. Under Food and Drug Administration
(FDA) expanded access programs and federal emergency
guidelines, COVID-19 clinical trials have been some of the most
successful trials to date. However, significant challenges have been
presented for both Clinical Research Organizations (CROs) and
the sponsoring companies, as a result of the COVID-19 pandemic.

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Published

2021-01-22