CLINICAL TRIAL CENTRAL LAB SERVICES
Our guiding principles:
- Access to outstanding faculty expertise for a broad spectrum of trial needs
- Entrepreneurial spirit within an academic environment
- Consultative services tailored with the project sponsor’s objectives in mind
URMC LABS, operated under the Department of Pathology and Laboratory Medicine at the University of Rochester, has provided outstanding clinical laboratory services since 1925. In 1995, the laboratory began providing multi-center central lab services to NIH-funded clinical trials.
The demand for clinical trials laboratory services grew steadily as a result of the University of Rochester’s expanding research efforts. In 2006, a university investment program was launched to provide GxP-compliant central laboratory services to provide such services to pharmaceutical, biotechnology and contract research organizations within the University’s orbit.
URMC LABS serves inpatient and outpatient populations and researchers in New York State, and across the United States and Canada. In 2008, with a staff of 700 laboratory professionals, URMC LABS conducted more than nine million laboratory assays and supported hundreds of research projects. It currently provides clinical and anatomic pathology services for more than 450 clinical trial studies. Growing demand for specialized central laboratory services led to the creation of a new laboratory location four miles from the main campus, dedicated to the support of clinical trials and research projects.
The faculty and staff of URMC LABS bring decades of experience in clinical and research laboratory analysis, pharmaceutical industry and global central laboratories. URMC LABS is accredited by or compliant with:
- College of American Pathologists (CAP# 1279904)
- Clinical Laboratory Improvement Amendment- CLIA #s 33D1068640/ 33D0173384
- New York State Department of Health (PF1#8305 and 2093)
URMC LABS offers flexible solutions and collaborative services – including project management, specimen collection kit supply, safety testing and assay development/technology transfer. Staff members have specialized industry experience in quality assurance, project management, data management and assay development. URMC LABS consults closely with investigator sites at the University of Rochester, fostering a unique understanding of the challenges faced in conducting research sponsored by government, foundations, and pharmaceutical, biotechnology and diagnostic enterprises.