Validcare has been contracted by Bubs Australia to manage a Growth Monitoring Study (GMS) involving 440 healthy term infants. This research aims to establish acceptable growth and tolerance data for three Bubs products to obtain permanent U.S. Food and Drug Administration (FDA) market authorization while the company continues importing under the agency’s enforcement discretion policy.
Study Details
The nationwide study operates across 13 clinical research sites and evaluates all three Stage 1 Bubs formulas—one goat’s milk-based and two cow’s milk-based products—alongside a commercially available control formula. The research includes a breastfeeding reference group and gathers input from healthcare professionals, parents, and caregivers.
Richard Paine, COO of Bubs Australia, emphasized that “Validcare’s performance-based model, plus decades of infant formula experience, provides us with confidence in their management of this large-scale study.” He noted their approach automates most study interactions and data collection from recruitment through database finalization.
Technology Innovation
Validcare’s smart data capture system proactively alerts investigators when measurements fall outside protocol limits and automatically calculates final inputs. Michael B. Montalto, PhD and scientific advisor for Bubs Australia, highlighted how this electronic system “improves data integrity and makes it easy for clinicians to accurately enter growth data.”
Rod Nuss, COO of Validcare, described this as “one of the largest infant formula studies on record,” with completion targeted before the FDA’s September 2024 deadline.
The study is registered on clinicaltrials.gov and approved by Advarra’s Institutional Review Board.