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

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.