Frenova Renal Research

Renal

Frenova Renal Research is the only Phase I-IV drug and device clinical development services provider dedicated exclusively to renal research. As a Fresenius Medical Care North America company, Frenova maintains a world-class network of resources encompassing more than 200 principal investigators and 250 dialysis research sites. We also offer access to more than 183,000 active ESRD patients and 390,000 active CKD patients.

By pairing this extensive network with our bioinformatics capabilities to assess your protocol feasibility, drive patient recruitment and enrollment strategies and more, Frenova gives you confidence you can’t get anywhere else. No other clinical development services provider works with a more intimate understanding of patients affected by kidney disease and its comorbid conditions than we do. When you need to conduct a complete renal clinical program, trust the partner that’s completely renal —

Frenova Renal Research.

Completely Renal

Clinical development

Frenova’s renowned team of nephrology specialists and clinical development resources make us the leader in renal research. Access to:

  • 390,000+ active chronic kidney disease (CKD) patients
  • 183,000+ active end stage renal disease (ESRD) patients

Renal site network 

As a Fresenius Medical Care North America company, Frenova maintains the world’s largest network of renal resources — we’re everywhere you need us to be, and beyond.

  • 200+ principal investigators,
  • 250+ dialysis research centers
  • 2,200+ dialysis facilities

Bioinformatics and analytics

After more than 25 years of collecting dialysis data, our bioinformatics and analytics services serve as vital resources for everything from assessing protocol feasibility, selecting sites and conducting targeted patient recruitment, to determining sample size and defining best practices. Historical data on:

  • 393,000+ CKD patients
  • 980,000+ ESRD patients

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The Custom Reporting and Data Analysis Group is responsible for data mining the vast stores of data maintained in the Fresenius Medical Care Knowledge Center. The Knowledge Center houses years of detailed clinical and operational data and is updated nightly. For the past decade, our database has provided clinical insights and answers to clinical queries for our medical staff and stakeholders such as CMS. In addition to serving as a resource for internal epidemiologic and quality improvement analyses, the Knowledge Center provides a rich database for external clients who have a need to analyze such data for specific information.

Review and approval processes ensure data extracts follow HIPAA and FDA regulations. Data extracts may be subject to other restrictions that apply to each data set requested.

Clinical Science, Epidemiology and Research Group

Analyzing the past to understand the present. See: Fresenius Medical Care North America Medical Literature Bibliography for 2005-2016.

Clinical and epidemiological research in the dialysis environment requires specialized knowledge to:

  • understand the patient population
  • construct plausible hypotheses
  • consider issues related to dialysis treatments that require protocol modifications
  • consider the endpoints that are appropriate, measurable, and practical for the data analysis.

Our team of epidemiologists and biostatisticians utilize data from the Knowledge Center and from clinical trials involving our dialysis patients in hypothesis-driven research. We employ epidemiological principles and advanced statistical methods that minimize bias. Our biostatisticians are adept in routine parametric and nonparametric statistical tests, as well as sample size and power calculations for clinical studies.

We utilize correlation analyses, regression models, and survival analyses. We carefully build our models to adjust for appropriate risk factors, whether they are related to case-mix and demographic distributions, laboratory values, comorbid conditions, or other variables within our extensive database. Whenever appropriate, we apply time varying analyses, marginal structural models, propensity scores, and hierarchical models.

Because analyses of associations between predictor variables and clinical outcomes in this diverse population with multiple comorbidities often have unexpected results not consistent with the general population, having an experienced team is essential . We have the experience to accurately and comprehensively analyze any aspect of dialysis treatment. Some of the areas explored by our investigators and biostatisticians are:

  • studies involving clinical variables and clinical outcomes
  • defining best practices
  • defining clinical problems
  • exploring clinical targets
  • elucidating outcomes associated with the use of certain clinical algorithms
  • clinical processes/practices, medications
  • new technologies

Our epidemiological studies have been published in the leading medical and nephrology journals over the past decade.

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Frenova Renal Research Leadership:

Kurt Mussina, BS, MBA Vice President, General Manager
Ann Mooney, MSN, RN, CNN Senior Director, Clinical Operations
Brigid Flanagan, MS, RN, CCRC Senior Director, Clinical Development
Russell Smith, BS, MBA Senior Director, Business Operations
Christina Marie Kahn, BS, CCRP Director, Frenova Site Innovation

Clinical Science, Epidemiology and Research Group:

Norma Ofsthun, PhD Vice President Data Analytics-Reporting, Algorithms & Research
Len Usvyat, PhD Vice President Integrated Care Analytics & Research
Kevin Chan, MD Senior Director, Analytical Research

 

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