Curavit Completes Key Recruitment for The APPROVE Trial
Curavit Clinical Research, recognized as "The Innovation CRO," has made significant advancements in clinical trials by successfully recruiting half of the required participants for The APPROVE Trial well ahead of schedule. This achievement marks a pivotal moment in their commitment to transforming healthcare through innovative solutions.
The APPROVE Trial is a pioneering randomized study that is evaluating the effectiveness and safety of a prescription digital therapeutic designed specifically for the treatment of overactive bladder in women. The trial compares the newly developed prescription digital therapeutic (PDTx) application known as RiSolve against conventional behavioral education methods.
Curavit was selected for its expertise in the Virtual Clinical Site model, tasked with enrolling 298 out of the total 596 study participants within a tight timeframe of six months. This undertaking required a meticulous screening and enrollment process that involved the collection of medical records and participants keeping a multi-day diary for accuracy throughout the study.
Efficiency in Recruitment Process
Despite the rigorous requirements of the study, Curavit's advanced Virtual Clinical Site platform, STRATUS, enabled them to complete participant recruitment in a remarkable four months. This achievement highlights Curavit's ability to effectively utilize digital solutions to streamline clinical research.
Brendan Staunton, CEO of Amara Therapeutics, emphasized Curavit's exemplary performance, stating, "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. Curavit provides both exceptional performance and significant strategic value." This statement underlines the importance of collaboration among innovative healthcare organizations.
Partnerships Supporting Innovation
Joel Morse, CEO and co-founder of Curavit Clinical Research, expressed pride in their collaboration with Amara Therapeutics and MedStar Health to advance RiSolve DTx. He stated, "Our mission is to raise the standard of care for women living with incontinence by providing accessible and evidence-based solutions, which aligns perfectly with Amara's vision. This trial serves as a strong validation of the decentralized trial model and demonstrates how digital therapeutics and digital clinical trials can synergistically push the boundaries of healthcare innovation in women's health."
About Curavit Clinical Research
Curavit Clinical Research is at the forefront of modern clinical trials, focusing on medical devices, digital therapeutics, and innovative pharmaceuticals. Located in Boston, Massachusetts, Curavit combines full-service clinical research organization capabilities with a comprehensive Virtual Clinical Site approach to enhance patient access, shorten timelines, and improve overall patient experiences.
Commitment to Advancing Women’s Health
Amara Therapeutics is devoted to the development of digital therapies that empower women dealing with incontinence to regain control over their lives. Headquartered in Newcastle, Ireland, their innovative solutions provide evidence-based care accessible anytime, anywhere.
Integration with MedStar Health
MedStar Health emphasizes the importance of exceptional healthcare, integrating advanced medical education and clinical training. With over 30,000 associates and 4,000 affiliated physicians, they uphold a commitment to patient-centric care across a wide network of facilities including hospitals and urgent care centers.
Frequently Asked Questions
What is The APPROVE Trial about?
The APPROVE Trial evaluates the effectiveness and safety of RiSolve, a prescription digital therapeutic for women with overactive bladder.
Who is Curavit Clinical Research?
Curavit Clinical Research is a leading clinical research organization focused on modern trials for digital therapeutics and medical devices.
How was participant recruitment conducted?
Curavit utilized its Virtual Clinical Site platform to expedite the recruitment process while ensuring adherence to rigorous study protocols.
What benefits does the decentralized trial model offer?
The decentralized trial model enhances patient access, reduces recruitment timelines, and improves the overall experience of participating in clinical research.
Why is this research important for women's health?
This research aims to provide effective, evidence-based digital solutions that enhance the quality of life for women suffering from incontinence.
