Curavit Achieves Milestone in Virtual Recruitment for APPROVE Trial Ahead of Schedule

Curavit Achieves Recruitment Milestone for The APPROVE Trial

Curavit Clinical Research, known for its innovative approach as a contract research organization (CRO), has successfully reached a significant milestone. The company has recruited half of the participants required for The APPROVE Trial a remarkable two months earlier than planned. This trial aims to assess the efficacy and safety of a prescription digital therapeutic (PDTx) application named RiSolve for treating overactive bladder in women.

The APPROVE Trial is a multi-centered randomized study comparing the RiSolve application to traditional behavioral education methods. This important clinical investigation is conducted in collaboration with Amara Therapeutics and MedStar Health, a prominent academic health system spanning Maryland, Virginia, and Washington, D.C. These collaborations are essential for generating critical data required for FDA marketing clearance.

Curavit’s Virtual Clinical Site was pivotal in executing this recruitment strategy. Their goal was to recruit 298 out of the total 596 participants within a six-month timeframe. The thorough screening and enrollment process required considerable effort from participants, including giving consent for medical record collection and completing a detailed multi-day diary. Despite the complexity involved, Curavit leveraged its scalable Virtual Clinical Site platform, STRATUS, which facilitated the swift recruitment of participants within just four months.

Brendan Staunton, CEO of Amara Therapeutics, expressed his satisfaction with Curavit’s performance, stating, “Within just four months, they successfully recruited 298 participants—this clearly demonstrates the power and efficiency of their virtual site. This accelerated timeline not only reduces the duration of the study but also allows us to bring evidence-based digital therapies to women more swiftly.”

Joel Morse, CEO and co-founder of Curavit Clinical Research, echoed this sentiment by emphasizing the company’s commitment to advancing innovative digital therapeutics. “We are proud to partner with Amara Therapeutics and MedStar Health in bringing the RiSolve DTx to the market. Our mission aligns closely with that of Amara, which aims to improve the standard of care for women suffering from incontinence by providing accessible, evidence-based solutions,” he stated.

This achievement serves as a validation of the decentralized trial model, highlighting how digital therapeutics and digital clinical trials can collaboratively foster innovation in the realm of women's health. Curavit Clinical Research combines traditional CRO capabilities with an integrated Virtual Clinical Site to enhance accessibility, speed up timelines, and improve patient experiences in clinical trials.

Curavit Clinical Research is headquartered in Boston, Massachusetts, and focuses on designing and executing modern clinical trials for various medical devices, digital therapeutics, and innovative pharmaceuticals. They advocate for evidence-based practices that empower patients, especially women facing health challenges like incontinence.

Amara Therapeutics operates from Newcastle, Ireland, concentrating on developing digital therapies designed to help women manage incontinence and regain control of their lives. Their commitment to making evidence-based care available anytime and anywhere is a hallmark of their mission.

Through their work with MedStar Health and other healthcare partners, they aim to continually advance medical care and provide effective solutions for conditions previously deemed challenging to manage. As a part of this mission, the quick recruitment milestone showcases the potential of virtual clinical trials in the evolving landscape of healthcare.

This partnership not only reflects Curavit’s dedication to innovation in clinical research but also emphasizes the growing importance of digital solutions in delivering healthcare. By utilizing digital platforms like STRATUS, health systems can now reach patients more efficiently, potentially revolutionizing how clinical trials and therapeutic services are conducted across the globe.