(Frenova Rapid STart Up) to Speed Clinical Trial Initiation
Exclusive Alliance With Physician Investigators Reduces Administrative Delays and Elevates Value Offered to Pharma and Medical Device Sponsors
(Waltham, Mass; Feb. 11, 2016) - Frenova Renal Research, the world’s only drug and medical device contract clinical development services provider dedicated exclusively to renal research, announced today the launch of F1RST Up (Frenova Rapid STart Up), an exclusive alliance with recognized leading physician investigators in the nephrology research community.
F1RST Up accelerates study startup by eliminating the administrative and contracting burdens often cited as primary reasons clinical trials are delayed.
Frenova, a Fresenius Medical Care North America (FMCNA) company, has a 16-year history dedicated exclusively to improving the lives of patients living with kidney disease. F1RST Up represents an exclusive group of clinical research sites carefully selected from Frenova’s investigative site network of more than 200 physician investigators who provide care to approximately 600,000 kidney disease patients.
F1RST Up is comprised of large, high-performing research site businesses with demonstrated clinical research success in vascular access and care, cardio-renal conditions, chronic kidney disease (CKD), end stage renal disease (ESRD), cardiovascular disease, rare diseases, infectious diseases and transplant.
“F1RST Up was conceived and organized with value for all of our stakeholders in mind,” said Kurt Mussina, general manager of Frenova. “We worked very closely with our F1RST Up physician partners and clients to both identify and magnify the value drivers for our sites, sponsors and patients. F1RST Up works because it takes a no-nonsense approach to moving immediately from study award to study start, and that is the foremost value driver for sponsors.”
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
QWINT-1 Trial: Once-Weekly Efsitora Matches Daily Glargine in Type 2 Diabetes Management
July 10th 2025Results from the Phase III QWINT-1 trial show that Eli Lilly’s once-weekly insulin efsitora is noninferior to once-daily glargine in reducing HbA1c among insulin-naïve adults with type 2 diabetes, offering a simplified fixed-dose regimen with fewer hypoglycemic events and less treatment burden.