Nationwide clinical trial to study probiotic use in women’s health
November 11, 2021 9:03 AM EST
CASTLE PINES, Colo.–(BUSINESS WIRE)–Validcare is pleased to announce that Garden of Life® has contracted to use the Validcare StudyTM platform as a service (PaaS) in its ambitious plan to conduct the largest clinical trial ever performed in women for its industry leading Dr. Formulated Women’s Once Daily Probiotic. The IRB-approved, physician led clinical research will be conducted in the USA. The 21CFR Part 11 compliant app-based PaaS will be branded to Garden of Life and available on both android and iOS devices. Use of the platform allows investigators to enroll, consent and engage a diverse group of study participants across the country via their smart phone throughout the study.
According to a Wellcomms report earlier this year, consumers expect supplement brands to provide scientific proof that a product delivers on its promise. “We are excited to further advance the clinical research on the important role that probiotics play in helping to address women’s health concerns. For this large study, we want to reach a more diverse group of women across the US, and the Validcare platform allows us to do just that, providing our researchers real world scientific data in real time, as women are using our Women’s Once Daily probiotic,” said Jeff Brams, General Counsel and VP R&D and Regulatory at Garden of Life.
Many in-person clinical studies have been slowed or halted in the pharmaceutical, nutraceutical and supplement industry due to COVID restrictions. Decentralized and hybrid trials open the door for industry to re-design, re-start and even accelerate and improve studies. “We are excited to be chosen by Garden of Life to power its clinical research and enable them to conduct meaningful studies on their products in a decentralized manner to support their claims even in the face of COVID,” said Patrick McCarthy, CEO of Validcare.
Validcare provides patient-centered research solutions to transform the delivery of life sciences and nutraceutical products. Our technology and services place the patient’s voice at the center of product research, resulting in greater patient participation, improved scientific data, more reliable product claims and accelerated product development. Founded by experts with more than 20 years of industry experience, Validcare offers the leading solution for best practices in streamlining research for regulatory compliant, life-improving products.
For more information, visit Validcare or call 844-825-4322.
About Garden of Life
Garden of Life is today’s recognized leader and innovator in carbon-neutral-certified, whole food, Certified USDA Organic and Non-GMO Project Verified nutrition. Headquartered in Palm Beach Gardens, Florida, we offer more than 400 time-tested supplements by leading scientists – all to Empower Extraordinary Health. Whether we’re making a vitamin or a probiotic or a protein powder, we always start with fresh, real, whole foods that are traceable back to the seed. From there, these foods provide our formulas that give people of all ages the power to be their best.
Visit Garden of Life to learn more.