Curavit Clinical Research has achieved a significant milestone in digital therapeutics development, completing participant recruitment for the APPROVE trial two months ahead of schedule. The contract research organization successfully enrolled 298 participants in just four months for the randomized clinical trial evaluating RiSolve, a prescription digital therapeutic for overactive bladder treatment in women.
Virtual Site Model Drives Recruitment Success
The APPROVE trial represents a multi-centered randomized study comparing Amara Therapeutics' prescription digital therapeutic application RiSolve to standard behavioral education. Curavit was tasked with recruiting 298 of the total 596 study participants within six months using its Virtual Clinical Site platform.
Despite the complexity of the enrollment process, which required participants to consent to medical record collection and complete multi-day diaries spanning several days, Curavit's scalable virtual site approach enabled rapid recruitment completion. The company's STRATUS platform supported the virtual clinical site operations throughout the accelerated timeline.
"Curavit's role as the virtual site in The APPROVE Trial has been outstanding," said Brendan Staunton, CEO of Amara Therapeutics. "Within just four months, they successfully recruited 298 participants—clearly demonstrating the power and efficiency of their virtual site. This accelerated timeline reduces study duration and enables us to deliver evidence-based digital therapies to women faster."
Partnership Advances Women's Health Innovation
The APPROVE trial emerged from a collaboration between Amara Therapeutics and MedStar Health, a leading academic health system serving Maryland, Virginia, and Washington, D.C. The partnership aims to conduct a multi-site clinical trial generating key data to support FDA marketing clearance for the digital therapeutic.
Joel Morse, CEO and co-founder of Curavit Clinical Research, emphasized the alignment between the organizations' missions. "Amara's mission—to raise the standard of care for women living with incontinence by delivering accessible, evidence-based solutions—aligns perfectly with our commitment to supporting innovative digital therapeutics," Morse stated.
Decentralized Trial Model Validation
The successful recruitment demonstrates the potential of decentralized clinical trials to accelerate therapeutic development timelines. Morse noted that the achievement represents "another strong validation of the decentralized trial model, and a demonstration of how digital therapeutics and digital clinical trials can work hand-in-hand to drive innovation in women's health."
The trial's design focuses on evaluating both efficacy and safety of the prescription digital therapeutic for overactive bladder treatment, addressing a significant unmet need in women's healthcare. The accelerated recruitment timeline positions the study to deliver results more rapidly than traditional clinical trial approaches.
Curavit Clinical Research, headquartered in Boston, Massachusetts, specializes in designing and executing modern clinical trials for medical devices, digital therapeutics, and novel pharmaceuticals. The company combines full-service contract research organization capabilities with fully integrated virtual clinical site operations to expand access, accelerate timelines, and improve patient experience in clinical research.
