New Site Expands F1RST Up® Alliance, Increasing Volume of Patients Eligible for Clinical Trial Enrollment
Waltham, Mass., Aug. 2, 2018 – Frenova Renal Research, a division of Fresenius Medical Care North America (FMCNA) and the world’s only contract clinical research services provider dedicated exclusively to renal research, today announces the addition of a fifth clinical research site to its Site Management Organization (SMO). The new site in Baton Rouge, La., brings 6,000 chronic kidney disease (CKD) patients and 1,500 end stage renal disease (ESRD) patients in the care of the practice and adds three new principal investigators and 10 sub-investigators to the SMO, increasing the ability to quickly enroll patients in renal clinical trials.
The new site is led by Principal Investigator Michael W. Roppolo, M.D., of Renal Associates of Baton Rouge, L.L.C. Frenova will oversee all operational trial activities, including the training and management of Frenova’s clinical research staff working at the site. In addition, Frenova will manage research site protocol adherence, data quality, site payment, regulatory obligations to the FDA and IRB, drug accountability and site performance.
The Baton Rouge site also joins the F1RST Up (Frenova Rapid STart Up) Alliance of research sites, simplifying and expediting the startup of clinical trials investigating pharmaceuticals and medical devices designed to advance renal health worldwide.
“This important collaboration will bring more patients into our network who are eligible for renal-specific clinical studies, enabling us to support the increasing number of clinical trials seeking to improve the lives of people with renal disease,” said Kurt Mussina, vice president, general manager, Frenova Renal Research.
“It is a privilege to be part of Frenova’s growing Site Management Organization,” said Michael Roppolo, MD, Partner, Renal Associates of Baton Rouge, L.L.C. “Frenova SMO and the F1RST Up network are improving the health outcomes and quality of life for patients through important clinical research. By allowing Frenova to direct the clinical research staff and trial operations, we can enroll more patients into studies and ultimately help patients by introducing new advances and treatments to the market.”
To learn more about Frenova Renal Research’s clinical trial initiation program, read, “F1RST Up®: Accelerating Clinical Trial Start-Up” in Fresenius Medical Care North America’s 2018 Annual Medical Report.
About Frenova Renal Research
Frenova is the world’s only drug and medical device contract clinical development services provider dedicated exclusively to renal research and its adjacent conditions. As a Fresenius Medical Care North America company, Frenova manages a networked system of clinical research assets and resources including over 450 principal investigators at more than 260 sites representing 160 medical practices and nearly 700 dialysis clinics. Frenova manages clinical trials in kidney disease and its adjacent medical conditions. Visit www.FrenovaRenalResearch.com for more information.
About Fresenius Medical Care North America
Fresenius Medical Care North America is the premier health care company focused on providing the highest quality care to people with renal and other chronic conditions. Through its industry-leading network of dialysis facilities, outpatient cardiac and vascular labs and urgent care centers, Fresenius Medical Care North America provides coordinated health care services at pivotal care points for hundreds of thousands of chronically ill customers throughout the continent. As the world’s largest fully integrated renal company, it offers specialty pharmacy and laboratory services, and manufactures and distributes the most comprehensive line of dialysis equipment, disposable products and renal pharmaceuticals. For more information, visit the FMCNA website at https://fmcna.com/.