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After spending nearly 30 years specializing in Phase II-IV rheumatology studies, Metroplex Clinical Research Center (MCRC) is broadening its services by adding a Phase I unit in their research facility.
Metroplex Clinical Research Center Expands Phase I Studies
DALLAS, TEXAS-After spending nearly 30 years specializing in Phase II-IV rheumatology studies, Metroplex Clinical Research Center (MCRC) is broadening its services by adding a Phase I unit in their research facility. This addition answers an industry need for sites that can provide Phase I services as well as appropriate patient populations.
"Early phase research is critical for determining the absorption and metabolism of new investigational therapies as well as establishing their potential future dose," said Dr. Stanley B. Cohen, MCRC medical director.
Generally, in Phase I research, healthy volunteers are recruited for the studies but with newer therapies, small groups of individuals with well-controlled or minimally active disease are recruited. Study participants generally receive a single dose of the study medication and, over the next hours and days, blood and urine samples are obtained to measure the tolerability and levels of the study drug remaining in the body. Based on the information from these studies, dosing is determined for later stage studies which involve several hundred patients.
MCRC is centrally located on the campus of UT Southwestern at St. Paul University Hospital in Dallas, Texas. Over the years, MCRC has successfully completed more than 800 Phase I-IV multi-specialty clinical studies. The MCRC complex includes a full-service X-ray department with bone density testing, an onsite CLIA-certified laboratory, an onsite infusion unit and overnight accommodations in the Phase I facility.
Infrastructure aside, perhaps the site's most distinguishing feature is its leadership. MCRC is headed by Dr. Cohen and Roy M. Fleischmann, M.D., who have 50 years of combined clinical research experience between them, have published 350 scientific articles and abstracts and co-authored four medical books. Both Dr. Fleischmann and Dr. Cohen are clinical professors with UT Southwestern Medical School and are highly sought-after lecturers internationally on the subjects of research and treatment of arthritis and osteoporosis. In addition, both serve as advisors to major pharmaceutical companies.
"MCRC has been involved in developing new investigational rheumatoid arthritis medications for more than 25 years, serving as one of the original research sites to work with Enbrel® in 1993 and participating in the development of newer investigational drugs," Dr. Cohen continued. "The physicians at MCRC are heavily involved in designing, conducting and analyzing clinical trials as well as reporting the results at national and international scientific meetings."
The MCRC database contains the names of more than 3,000 healthy subjects and more than 19,500 individuals who have participated in clinical research studies or expressed an interest in participation. The site's therapeutic expertise spans areas such as over-the-counter prescriptions, obesity, hypertension, insomnia, gastrointestinal disorders, vaccines and smoking session.
For more information, contact Sara Hibbard at (214) 424-0400. Further details about MCRC are available at www.mcrcdallas.com