Development of a COVID-19 Vaccine: Challenges for Data Managers
The Veristat team had the chance to lead Data Management activities in one of the programs for the development of a COVID-19 vaccine. Since August 2021 our Data Management team has been working on this program which includes 5 trials so far, from early phase to phase III covering both healthy volunteers and immunocompromised subjects.
Timelines for the setup and cleaning activities for the different milestones (data cuts for interim analysis, DSMBs, etc) have been extremely tight to accommodate expectations and submission timelines to the authorities and hence our team had to adapt accordingly.
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