RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Quintiles, the world’s largest provider of product development and integrated healthcare services, today announced its Precision Enrollment offering. The new enrollment model is designed to significantly accelerate site start-up and patient recruitment in oncology clinical trials working with the company’s network of investigative sites across the U.S and leveraging secondary data (e.g. electronic health records-EHRs.) In this new model, the traditional site start-up pathway is realigned so a site is only opened after a patient is identified.
“The rise of precision medicine, scarcity of patients and investigators, combined with increasingly complex trial protocols, requires innovative approaches to clinical trial implementation,” said Cynthia Verst, PharmD, president, Clinical Operations at Quintiles. “This solution harnesses Quintiles’ deep therapeutic expertise in oncology, robust oncology investigator relationships and our demonstrated operational excellence to identify and recruit the right patient, from the right investigator, for the right oncology trial at the right time.”
Today, three out of five oncology treatments are targeted therapies, with efficacy in niche patient subpopulations.1 These factors can contribute to higher screen failure rates and pose critical challenges for recruiting patients that fit a particular trial profile. Conventional models for targeting these sub-populations and pre-screening of these patients are time- and cost-intensive, making it difficult for oncologists to find the study that fits the individual patient.
With Precision Enrollment, Quintiles has built a network of oncology sites with master contracts as well as centralized IRB capabilities to streamline patient identification and start-up. The program will enable pre-identification of patients based on study and biomarker criteria, across broad geographic areas, using EHRs and other secondary data sources before a site joins a study. By using this rapid start-up model, these pre-identified patients are quickly matched to specific protocol inclusion and exclusion criteria and site activation is designed to take less than 21 days.
“Our premier site network and strong relationships with investigators is an integral part of Precision Enrollment, and this approach can provide value to both pharmaceutical companies and patients alike,” said Jeanne Hecht, senior vice president and global head, Site & Patient Networks at Quintiles. “By opening a site only after a patient has been identified, we’re able to reduce zero-enrolling sites and associated time and costs, and most importantly, provide patients with quicker access to potentially life-saving treatments.”
Quintiles (NYSE: Q) helps biopharma and other healthcare companies improve their probability of success by connecting insights from our deep scientific, therapeutic and analytics expertise with superior delivery for better outcomes. From advisory through operations, Quintiles is the world’s largest provider of product development and integrated healthcare services, including commercial and observational solutions. Conducting operations in approximately 100 countries, Quintiles is a member of the FORTUNE 500 and has been named to FORTUNE’s list of the “World’s Most Admired Companies.” To learn more, visit www.quintiles.com.
1 McKesson Specialty Health/US Oncology Network. 2013
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