Intravaginal Contraceptive
Background: Smooth Drug Development was involved in the organization of an international Phase III clinical trial of a combined intravaginal contraceptive in healthy women at risk of pregnancy.
About a trial: The international clinical trial was organized by a global CRO in Europe, which repeatedly involved Smooth Drug Development as a partner CRO. We provided services for the submission of the clinical trial approval package, site selection and monitoring, study drug importation, and project management.
Challenges: No significant risks were foreseen in the study and no difficulties were encountered during the project. The sites recruited quickly - 125 subjects in 5 sites were enrolled in 2 months. The sites selected by our company had a patient enrollment rate twice that of the other sites.