Garden of Life has partnered with Validcare to conduct what the company describes as the largest clinical trial ever performed for women studying its Dr. Formulated Women’s Once Daily Probiotic supplement.
Decentralized Trial Technology
The IRB-approved research initiative will leverage Validcare’s Study platform-as-a-service, which operates as a branded mobile app for both Android and iOS devices. This 21CFR Part 11 compliant system enables researchers to enroll participants, obtain informed consent, and maintain engagement across diverse populations throughout the United States via smartphone technology.
Jeff Brams, General Counsel and VP of R&D and Regulatory at Garden of Life, explained the company’s motivation: “We want to reach a more diverse group of women across the US… providing our researchers real world scientific data in real time.”
Addressing Industry Challenges
The initiative addresses a significant industry challenge. Many traditional in-person clinical studies faced slowdowns or cancellations due to COVID-19 restrictions. Decentralized and hybrid trial models offer pathways for companies to redesign, restart, and potentially accelerate research efforts.
Patrick McCarthy, CEO of Validcare, emphasized the opportunity: “We are excited to be chosen by Garden of Life to power its clinical research and enable them to conduct meaningful studies.”
The research responds to consumer expectations, as documented in a Wellcomms report indicating that supplement consumers increasingly demand scientific validation supporting product claims.