Automated Sample Retention Solution for BA/BE Studies
Bioavailability and Bioequivalence (BA/BE) studies require samples of the investigational product to be retained. Typically, this is performed manually and overseen by clinical monitors during the site initiation. This manual approach is feasible for a limited number of sites. However, for studies with a large number of sites, the manual retention becomes less feasible, as it requires additional monitoring visits and the physical presence of study personnel.
In traditional manual BA/BE retention, there is no system audit trail generated, as this retention and review action occurs outside the system.