COSTA MESA, Calif., May 18, 2015 /PRNewswire-iReach/ -- California CRO WCCT Global recently completed a study on elderly subjects to access the safety and reversal of rivaroxaban anticoagulation. The study was a randomized, double-blind, placebo-controlled study in subjects between the ages of 50 and 75 years old. The study volunteers were administered rivaroxaban, a substance that is used to prevent strokes and embolic events in those with non-valvular atrial fibrillation. The volunteers were then administered the investigative treatment to evaluate its ability to reverse anticoagulation caused by rivaroxaban. The full-service CRO conducted this 4-day clinical research study on a treatment that designated as a breakthrough therapy by the U.S. Food and Drug Administration.
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The California CRO was able to successfully recruit multiple cohorts of normal healthy volunteers for the study, demonstrating the effectiveness of their data-driven patient recruitment strategy, called IN-SITE, which targets normal healthy volunteers and patient populations based on age, gender, interests, location, and lifestyle. IN-SITE makes use of cutting-edge digital recruitment methods to randomize patients by or before deadlines, which can prove difficult when a study calls for volunteers of specific age groups, health conditions, or lifestyles. WCCT’s IN-SITE patient recruitment strategy randomized nearly 60 volunteers who adhered to multiple protocol requirements for the study.
WCCT Global’s Director of Marketing, Matt Miller, comments on the strategies implemented by IN-SITE, which he attributes to the success of the system: “IN-SITE, above all else, is a data-driven patient recruitment strategy, which translates to a high level of efficiency, saving time and money for sponsors. IN-SITE identifies patients based on age, gender, lifestyle, interests, and location through multiple online venues, where we have the power to reach large audiences in a relatively short period of time. Thus, IN-SITE proves to be an effective tool for advancing clinical research in terms of identifying even the most difficult-to-recruit patients.”
The results of the study confirmed the effectiveness of the treatment to reverse rivaroxaban-induced anticoagulation. Because of the success of this and other studies, the sponsor is pursuing an Accelerated Approval pathway for the new treatment. The California CRO looks forward to seeing the new treatment come to market, where it can help patients who suffer from major bleeding episodes or require emergency surgeries.
More About WCCT Global:
WCCT Global is a multi-site, full service pharmaceutical contract research organization (CRO) of outsourced early drug development and late phase CRO services to the pharmaceutical, biotechnology and medical device industries. The WCCT Global vision, “With compassion for people, we strive for tomorrow’s therapies to be available today” truly exemplifies the focus and reason for our cutting edge work both in our clinics and throughout our operations. As a drug development partner, WCCT Global collaborates with domestic and foreign innovator companies who need regulatory, program management, patient recruitment, data management and strategic consulting support, with an emphasis on overseeing and executing trials in special disease populations, pediatric populations, ethno-bridging, and cardiac safety. WCCT has extensive experience with healthy volunteer studies including First-in-Human (FIH), as well as specific therapeutic expertise in Allergy, Asthma, HCV, Ophthalmology, Renal, and Vaccines
Media Contact:Matt Miller, WCCT Global, 714.668.1500 ext.2029, Matt.Miller@wcct.com
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