OVERLAND PARK, Kan.–(BUSINESS WIRE)–Dr. Vince Clinical Research (DVCR), a full-service Phase I-II contract research organization (CRO) announced a new solution to conduct renal and hepatic impairment studies. The solution leverages trusted relationships and more effective management of highly regarded specialty sites and Subject Matter Experts to optimize study timelines, ensure efficient recruitment and generate quality data in this highly competitive space. By combining DVCR’s full suite of clinical trial services with their sites’ expertise and thorough understanding of the patient populations required for these studies, this end-to-end solution will challenge the current landscape for managing organ impairment studies.
“Renal and hepatic impairment studies present a set of challenges not seen in most other clinical pharmacology trials because there are a limited number of experienced sites with access to the necessary patient populations,” said DVCR CEO and Medical Director Bradley Vince, D.O. “Furthermore, successfully conducting organ impairment trials requires a unique approach with our sites which enables them to deliver results to their maximum potential.”
DVCR’s trusted relationships with these specialty sites cater to the specific demands of these trials and offer sponsors seamless access for their research,” says Korey Nevitt, DVCR’s Executive Director of Site Partnerships. He continues: “We take a hands-on approach to managing our partner sites for renal and hepatic impairment studies, ensuring streamlined operations and optimal performance in everything from patient enrollment to data management, medical writing and more.”
One such site which DVCR has partnered with is Elixia, and their Chief Scientific Officer Harry Alcorn, Pharm.D., who has served as an investigator on over 350 renal and hepatic impairment protocols. “Conducting these specialty population studies while ensuring the safety of the patients and obtaining quality data demands a long-term relationship,” said Alcorn, “You have to make sure that sites are being properly supported and given the tools they need to succeed by a CRO partner with the knowledge and experience required for these studies. Even better if you are working with a CRO that understands the nuances of clinical pharmacology studies with respect to operations, timelines, and financial components. This is why we are thrilled to be partnering with Dr. Vince Clinical Research on upcoming renal and hepatic studies.”
Read our interview with Harry Alcorn regarding best practices for conducting renal and hepatic impairment studies.
DVCR looks forward to offering this additional service to its current and future biopharmaceutical Sponsors to support their NDA submission packages.
About Dr. Vince Clinical Research
Dr. Vince Clinical Research (DVCR) is a full-service contract research organization (CRO) specializing in early phase trials in both healthy normal volunteers and patient populations across a wide range of trial designs and therapeutic areas such as neuroscience, substance abuse, pain, cardiometabolic disorders, infectious diseases and many others. CRO services include project management, data management, biostatistics, statistical programming, PK/PD analysis, medical writing, monitoring as well as site feasibility and management for multi-site trials. Additionally, DVCR operates one of the most innovative and technologically advanced clinical pharmacology units in the world with over 90 beds for overnight confinement, a cGMP compliant pharmacy as well as luxurious amenities to support diverse study participant recruitment and retention. By leveraging technology and one of the country’s most experienced leadership teams in early clinical development, DVCR provides Smarter Faster Data® to their biopharmaceutical clients.
For more information, go to sponsors.drvince.com. Connect with Dr. Vince Clinical Research on LinkedIn and YouTube.
About Elixia
Elixia is an innovator in patient recruitment and clinical trials management and analysis for three targeted therapeutic areas: Cardiology/Nephrology, Behavioral Health and Infectious Disease. Our break-through approach helps drug developers not only meet milestones with record speed and agility, but enroll and retain the right patients, trial after trial. We eliminate traditional trial bottlenecks with a singular combination of specialized clinical expertise and an agile operating model with reproducible processes to deliver start-up and enrollment at uncommonly remarkable speed. Our team of seasoned industry leaders creates a strategy for success from early phase through commercialization, across a sponsor’s entire pipeline. Partnering with Elixia, you get access to top leaders across different sectors of healthcare to drive value in clinical trials and forge better patient outcomes.
DVCR Contact
Zach Bader
Vice President, Business Development
(913) 333-3000
Dr. Vince Clinical Research
info@drvince.com