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SCOPE Summit 2022

February 7-10, 2022

DCTs & Devices: Lessons Learned From a Women's Health Med Device Trial

"Kegel" exercises are considered the most effective, non-invasive treatment for stress urinary incontinence in women. However, more than 75 percent of women perform these exercises incorrectly. Renovia, an innovative digital therapeutics company dedicated to improving women’s Pelvic Floor Health partnered with ObvioHealth a Decentralized Clinical Trial expert, to evaluate the efficacy of an at-home pelvic digital health system (PDHS) benchmarked against the current standard of care. The 8-week randomized trial amongst 350 women in the US was the first fully virtual study in the urogynocological category. Women used a downloadable app to report on symptoms while also capturing actual device use. This enabled the virtual team to closely track progress, measure adherence and engage with participants accordingly. Sponsor and CRO will discuss the findings and the implications for study design going forward.

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Virtual Trial Journey

A Seamless End-to-End Experience

ObvioHealth studies are run on our purpose-built platform by our own in-house virtual team. This allows us to work seamlessly from protocol design all the way through to analysis and reporting.

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ObvioHealth's Numbers

Up to 4x

Faster Recruitment

3 mo ObvioHealth average vs 12 mo benchmark for site-based trials

89%

Retention Rate

average retention vs. 70% benchmark for traditional trials

90%

ePro Compliance

average per study (digital questionnaires, daily ediary, etc.).

Our Client Roster

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mithra logo.
Mizkan logo.
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Our Virtual Platform Enables Remote Clinical Research

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