Veristat partners to achieve key enrollment milestone for study; activated 26 sites and enrolled more than 100 participants
SOUTHBOROUGH, Mass.--(BUSINESS WIRE)--#Veristat--Veristat, a global clinical research organization (CRO) and consultancy specializing in complex studies, announces its successful partnership with Cook MyoSite to support the DigniFI Study, a two-stage, randomized, controlled Phase III trial comparing the safety and efficacy of iltamiocel with placebo in the treatment of female participants with chronic fecal incontinence (FI) and a history of obstetric anal sphincter injury (OASI). Veristat successfully supported Cook MyoSite in onboarding 26 sites and enrolling more than 100 participants with >95% study adherence to meet a critical milestone for the study.
Chronic fecal incontinence (FI) is characterized by the unintended loss of liquid or solid stool occurring for at least 6 months. A common cause of chronic FI in women is anal sphincter injury, which can occur during childbirth. New treatment options are needed for these women who can experience profound negative impacts to their quality of life.
“Cook MyoSite has been researching and advancing personalized cell therapy treatment for women who have historically been underserved,” said Ron Jankowski, Cook MyoSite Vice President of Regulatory and Scientific Affairs. “We look forward to seeing the outcome of the study and the potential impact for women suffering from chronic FI in the future. As the CRO for the trial, Veristat helped conduct this momentous clinical study for a patient population with extremely limited options. Together, we have reached this key health milestone.”
Veristat is a full-service global CRO that takes a collaborative approach to navigating the process of bringing novel therapies to patients. A leader in clinical trial management, the company applies advanced biostatistical methods to complex studies and involves a fully integrated team of clinical, medical, biostatistical, and regulatory experts from early study planning to regulatory approval and beyond. Veristat’s comprehensive clinical trial management model reduces drag on timelines to achieve enrollment milestones and enables sponsors to hit their market goals and help more patients. The company has supported the regulatory approval of more than 100 therapeutics, including 39 oncology drugs, over 30 years.
Veristat Chief Strategy Officer Cindy Henderson, who has been actively involved in the Cook MyoSite trial, concluded, “Cook MyoSite represents the best of clinical development. They are passionate about solving unmet clinical needs for as many patients as possible using the most advanced personalized medical science. We are honored to partner with such an innovative and committed organization and look forward to continuing the journey to approval by their side.”
Veristat CEO Patrick Flanagan will be speaking at the third annual Clinical Outsourcing Group conference in San Francisco (Oct 21-22) Learn more about Veristat here.
About Veristat
Veristat is a full-service CRO and consultancy that helps life sciences companies bring novel therapies to market fast. With 30 years of experience and support in more than 100 regulatory approvals and deep expertise in rare disease, neurological disease, oncology, and advanced therapies, Veristat integrates strategic planning, regulatory insight, and trial execution to overcome complex challenges and accelerate success. From early planning through approval, Veristat delivers tailored solutions that drive meaningful outcomes for patients worldwide.
Contacts
Media Contact:
Lisa Barbadora, Barbadora INK for Veristat
+1 (610) 420-3413
lbarbadora@barbadoraink.com
