URMC Launches New Clinical Trial Service

September 02, 2008

The University of Rochester Medical Center (URMC) and the Clinical Trials Coordination Center (CTCC) have launched a new venture that provides a comprehensive array of supply services to researchers running clinical trials. The Clinical Materials Services Unit (CMSU) will assist researchers in the often complex and cumbersome process of distributing investigational drugs to study sites.

“The Clinical Materials Services Unit is built upon a large body of collective experience in running some of the more complex clinical studies in the world,” said URMC Professor of Neurology, Karl Kieburtz, M.D., M.P.H., “We decided to create this venture because we believe that we bring to the table a unique perspective on the challenges that clinical researchers face and can help develop solutions that meet their needs and budgets.”

The CMSU brings together a highly experienced team of researchers, pharmacists, clinical supply and quality assurance managers to offer a broad array of critical services to investigators involved in government, foundation and industry-sponsored multi-center clinical trials. These include package and label design and production, assembly of patient kits, national and international distribution, secure storage with robust environmental controls and the tracking and destruction of returned products. The CMSU will also ensure that supplies and service are in compliance with federal and international regulatory standards and requirements.

Changes in the drug development practices have resulted in pharmaceutical companies moving away from early stage clinical studies. This – coupled with the increasing scarcity of federal resources for clinical investigations – means that many promising therapies being pursued by academic investigators and smaller companies must find cost effective and efficient ways to conduct their research.

The CMSU is uniquely positioned to meet the industry needs because it is founded on decades of CTCC oversight of large clinical studies, during which time it has been able to develop, validate, and implement industry-leading practices that meet the supply needs of researchers.

The CTCC – a research unit of the University’s Department of Neurology – is the hub of the world's largest networks for clinical trials of new treatments for neurological conditions. The CTCC – which was created in 1986 and oversees an average of $25 million of clinical studies per year – consists of approximately 85 staff members and supports a full array of essential clinical trial services for industry, foundations, and government sponsors. URMC physicians have designed and headed some of the largest clinical trials ever in the treatment of several neurological diseases, including Parkinson’s and Huntington’s diseases.

The Clinical Services Materials Unit – which is based at the Rochester BioVenture Center on Ridgeland Road in Henrietta – will be run by the CTCC in cooperation with the URMC Department of Pharmacy.

For more information, visit: http://www.clinicalmaterial.com or call 585-350-3838.

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