Fresenius Medical Care North America (FMCNA) is the leading provider of dialysis care, dialysis products and specialized renal laboratory services in the United States. Through our network of more than 1800 dialysis facilities, we are the largest provider of ongoing dialysis treatment, serving over 134,000 active patients annually. In addition, we have a network of investigators experienced in research within the Chronic Kidney Disease (CKD) population in outpatient nephrology practices. Led by Nephrologists and other health care professionals with extensive experience in clinical research management, the Clinical Studies Department (CSD) works collaboratively with research sponsors to coordinate and facilitate multi-center research activities and evaluate their safety and feasibility in both the dialysis and pre-dialysis setting. We help to ensure that research is safe for our patients and meets all federal, state, and Good Clinical Practice guidelines.

The CSD works exclusively as an Investigational Site Network of more than 125 investigational sites and employs trained and experienced study coordinators. This model helps to ensure compliance with all state and federal guidelines as well as protocol adherence and timely completion of data collection.

The CSD Investigational Site Network has regularly met or exceeded enrollment targets in most of the multi-center clinical trials undertaken to date. Our investigators have experience with all phases of clinical research, with focus on Phase I to IV trials. The CSD is also available to assist investigators who wish to design and implement their own research projects, helping to ensure that investigator initiated projects meet all regulatory and safety requirements.

The CSD also maintains one of the largest renal health care databases in the country. The data is captured in the "Knowledge Center" as part of the routine patient care that is offered at Fresenius Medical Care dialysis facilities. The Knowledge Center contains years of detailed clinical and operational data, and is updated on a daily basis.

As the world's largest provider of dialysis services, Fresenius Medical Care has tremendous experience in the care of dialysis patients. Our unique database captures data on over 650,000 dialysis patients, 140 million dialysis treatments, 500 million medication administrations, and nearly 600 million lab results. It is a powerful tool that can be used to evaluate therapies and identify trends.

Clinical Study Department Services

• Site selection
• Multi-site collaboration
• Contract and budget negotiation
• Patient enrollment evaluation and management
• Ongoing quality assessment audits
• Timely collection and transfer of data
• Quarterly sponsor payment processing to investigational sites
• Consultation and refinement of protocol design
• Source document development
• IRB submission
• Review of eligibility criteria against Fresenius Knowledge Center to determine potential enrollment capabilities
• Collaboration with Spectra Renal Research for central laboratory services
• Troubleshooting and facilitation of communications between the Site and Sponsor/CRO
• GCP audits
• Clinical Trial Management
• Clinical trial monitoring services
• Select CRO services

Sarah E. Edmiston, M.Ed.
Corporate Study Coordinator
Fresenius Medical Care North America, Clinical Studies Department
750 Old Hickory Blvd, Suite 230
Brentwood, TN 37027
USA
615-345-5693
615-345-5515 (fax)
research@fmc-na.com
www.fmcna.com