Background
A biopharmaceutical company focused on delivering innovative products for women’s health chose us to manage their Phase 3 clinical trial evaluating an investigational, thermosetting, bioadhesive hydrogel for bacterial vaginosis (BV). We leveraged our expertise in study design and execution along with our extensive network of OB/GYNs to deliver a successful clinical study ahead of schedule.
This multicenter, randomized, double-blind, placebo-controlled study of treatment for women with bacterial vaginosis was set to begin just as COVID-19 was shutting down much of the United States. Clinical site engagement and patient enrollment were threatened by fear of the pandemic, local stay-at-home orders, and altered clinic procedures. The sponsor did not, however, want to delay the study start as bacterial vaginosis is a significant health issue facing women.
