Background: During the COVID-19 pandemic, which was rapidly gaining momentum, many companies were thinking not only about vaccine production, but also about drugs to treat the disease, including severe forms. Our company acted as a global CRO and was responsible for the global project management, data processing, biostatistics.
About a trial: The trial was conducted in 2 countries: in Spain and EAEU. Smooth Drug Development provided the full range of services in the project. There were 8 sites in EAEU and 6 sites in Spain. 400 patients were recruited in 12 months.
Challenges: By the time the trial was approved in EAEU, more than 100 trials of COVID-19 medicines had already been initiated. Many sites were loaded with trials in this nosology. PI and site budgets proposed in this study were lower than the grant offered by global pharmaceutical companies with ongoing projects. In addition, all centers with expertise in trials were already involved in other projects in COVID-19. Therefore, in order to meet the project deadlines, we involved centers with no experience in clinical trials, but who had access to a big number of subjects, thus ensuring the successful completion of the study. The centers were thoroughly trained in clinical trials and GCP. All activities of the centers were monitored by our CRO staff and the quality department.