Pregnancy registries gather health information from women who take prescription medicines or vaccines when pregnant and compare it with data from women who have not taken medicine during pregnancy. These registries play a vital role in improving safety information for medicines used during pregnancy and informing drug labeling.
The single country study aimed to enroll 800 patients and compare the maternal, foetal, and infant outcomes of women exposed to the sponsor’s drug during pregnancy with outcomes in an unexposed comparator population. The CRO needed to implement a data capture and eConsent solution that could support the requirements of this study while establishing a streamlined process adaptable for future projects with similar parameters. They turned to Cisiv for support as experts in real world evidence and late phase data capture technology.