COVID-19 vaccine

Background: Since the COVID-19 pandemic began, many pharmaceutical companies had been thinking about creating a vaccine. To stop the disease spreading, a vaccine clinical trial needed to be conducted as quickly as possible, not forgetting the quality of the data. Smooth Drug Development was actively involved in one of such trials.

About a trial: Smooth Drug Development participated in an international study. Our goal was to include 5,000 subjects and to find and connect sites willing to vaccinate and follow-up subjects to the study. We opened 12 clinical centers, 5 of which recruited 5,000 subjects in 2 months with our support.

Challenges: The extremely important task was to recruit the subjects as quickly as possible, namely, within a period of 2 months, which we successfully accomplished. During the height of the pandemic, we also encountered difficulties in importing equipment and materials and exporting biological samples due to logistical constraints caused by Covid-19 in the Sponsor's country. However, our logistics company was able to resolve the problems with the export of the IP from the Sponsor's country and the importation of the samples. In addition, a full-scale vaccination program with already registered drugs began in the country of the study, accordingly, the motivation of the subjects to participate in the study greatly decreased. Also the study was conducted in the peak of the pandemic, so the number of non-sick subjects was limited. Daily work with the sites and investigators and the rapid work of the laboratory allowed us to achieve the goals set by the Sponsor.