Effective CRO project management and fast track study set-up for an investigator initiated COVID-19 study
BACKGROUND PHARMExcel was selected to manage a UK, Phase II, combined Investigational Medicinal Product (IMP)/Medical Device study for COVID-19 patients hospitalised in ICU. We were asked to provide Project Management (PM), Monitoring and Safety oversight for the study, from protocol development to close-out. The study involved two sites and numerous teams responsible for key elements…